FARXIGA Drug Patent Profile

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Which patents cover Farxiga, and when can generic versions of Farxiga launch?

Farxiga is a drug marketed by Astrazeneca Ab and is included in one NDA. There are eighteen patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and forty patent family members in fifty-one countries.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dapagliflozin profile page.

DrugPatentWatch^® Generic Entry Outlook for Farxiga

Farxiga was eligible for patent challenges on January 8, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 16, 2030. This may change due to patent challenges or generic licensing.

Annual sales in 2021 were $2.7bn, indicating a strong incentive for generic entry.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are twelve tentative approvals for the generic drug (dapagliflozin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for FARXIGA

International Patents:	440
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	49
Patent Applications:	148
Drug Prices:	Drug price information for FARXIGA
Drug Sales Revenues:	Drug sales revenues for FARXIGA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FARXIGA
What excipients (inactive ingredients) are in FARXIGA?	FARXIGA excipients list
DailyMed Link:	FARXIGA at DailyMed

Drug patent expirations by year for FARXIGA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FARXIGA

Generic Entry Date for FARXIGA^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 7,919,598PED NDA: 202293 Dosage:* TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FARXIGA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The University of Hong Kong	Phase 2
University Health Network, Toronto	Phase 2
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 4

See all FARXIGA clinical trials

Pharmacology for FARXIGA

Drug Class	Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Sodium-Glucose Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for FARXIGA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FARXIGA	Tablets	dapagliflozin	5 mg and 10 mg	202293	20	2018-01-08

US Patents and Regulatory Information for FARXIGA

FARXIGA is protected by eighteen US patents and five FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FARXIGA is ⤷ Subscribe.

This potential generic entry date is based on patent 7,919,598.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes	8,431,685*PED	⤷ Subscribe			Y	⤷ Subscribe
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes	8,716,251*PED	⤷ Subscribe			Y	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for FARXIGA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	7,563,871	⤷ Subscribe
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	6,936,590	⤷ Subscribe
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	6,936,590	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for FARXIGA

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Forxiga	dapagliflozin	EMEA/H/C/002322 Type 2 diabetes mellitusForxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureForxiga is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseForxiga is indicated in adults for the treatment of chronic kidney disease.	Authorised	no	no	no	2012-11-11
AstraZeneca AB	Edistride	dapagliflozin	EMEA/H/C/004161 Type 2 diabetes mellitusEdistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureEdistride is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseEdistride is indicated in adults for the treatment of chronic kidney disease.	Authorised	no	no	no	2015-11-09
Viatris Limited	Dapagliflozin Viatris	dapagliflozin	EMEA/H/C/006006 Type 2 diabetes mellitusDapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance.- in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureDapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.Chronic kidney diseaseDapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.	Authorised	yes	no	no	2023-03-24
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for FARXIGA

When does loss-of-exclusivity occur for FARXIGA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1730
Patent: ESTRUCTURAS DE CRISTAL DE INHIBIDORES SGLT2 Y PROCESOS PARA PREPARAR LOS MISMOS
Estimated Expiration: ⤷ Subscribe

Australia

Patent: 07265246
Patent: Crystalline solvates and complexes of (IS) -1, 5-anhydro-L-C- (3- ( (phenyl) methyl) phenyl) -D-glucitol derivatives with amino acids as SGLT2 inhibitors for the treatment of diabetes
Estimated Expiration: ⤷ Subscribe

Brazil

Patent: 0713544
Patent: solvatos cristalinos complexos de derivados de (1s)-1,5-anidro-1-c-(3-((fenil) metil)fenil)-d-glucitol com aminoÁcidos como inibidores de sglt2 para o tratamento de diabetes
Estimated Expiration: ⤷ Subscribe

Patent: 2017015106
Patent: estrutura de cristal de formula 1b e composição farmacêutica
Estimated Expiration: ⤷ Subscribe

Patent: 2017021516
Patent: processo de preparação de uma estrutura de cristal de solvato de (s)-propileno glicol de fórmula ia
Estimated Expiration: ⤷ Subscribe

Canada

Patent: 53344
Patent: SOLVATES CRISTALLINS ET COMPLEXES DE DERIVES DE (IS)-1,5-ANHYDRO-L-C-{3-[(PHENYL)METHYL]PHENYL}-D-GLUCITOL AVEC DES ACIDES AMINES EN TANT QU'INHIBITEURS DE SGLT2 POUR LE TRAITEMENT DU DIABETE (CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-1-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS ASSGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Subscribe

Patent: 24318
Patent: SOLVATES CRISTALLINS ET COMPLEXES DE DERIVES DE (IS)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL-D-GLUCITOL AVEC DES ACIDES AMINES EN TANT QU'INH IBITEURS DE SGLT2 POUR LE TRAITEMENT DU DIABETE (CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Subscribe

Patent: 85797
Patent: SOLVATES CRISTALLINS ET COMPLEXES DE DERIVES DE (IS)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL-D-GLUCITOL AVEC DES ACIDES AMINES EN TANT QU'INH IBITEURS DE SGLT2 POUR LE TRAITEMENT DU DIABETE (CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Subscribe

Chile

Patent: 07001915
Patent: Compuesto cristalino de 6-[4-cloro-3-(4-etoxibencil)fenil]tetrahidropiran-2,3,4,5,-tetraol; procedimiento de preparacion; composicion farmaceutica que comprende a dicho compuesto; y su uso para preparar un medicamento para tratar diabetes, dislipidemia, obesidad, entre otras.
Estimated Expiration: ⤷ Subscribe

China

Patent: 1479287
Patent: Crystalline solvates and complexes of (is) -1, 5-anhydro-l-c- (3- ( (phenyl) methyl) phenyl) -d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes
Estimated Expiration: ⤷ Subscribe

Patent: 3145773
Patent: Crystalline solvates and complexes of (IS) -1, 5-anhydro-L-C- (3- ( (phenyl) methyl) phenyl) -D-glucitol derivatives with amino acids as SGLT2 inhibitors for the treatment of diabetes
Estimated Expiration: ⤷ Subscribe

Colombia

Patent: 60299
Patent: SOLVATOS CRISTALINOS Y COMPLEJOS DE DERIVADOS DE (1S)-1,5-ANHIDRO-1-C-(3-((FENIL)METIL)FENIL)-D-GLUCITOL CON AMINOÁCIDOS COMO INHIBIDORES SGLT2 PARA EL TRATAMIENTO DE DIABETES.
Estimated Expiration: ⤷ Subscribe

Croatia

Patent: 0141007
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Cyprus

Patent: 15738
Estimated Expiration: ⤷ Subscribe

Denmark

Patent: 69374
Estimated Expiration: ⤷ Subscribe

Eurasian Patent Organization

Patent: 8229
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА (CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
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Patent: 0428
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-С-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА (CRYSTALLINE SOLVATES OF (IS)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Subscribe

Patent: 8259
Patent: КРИСТАЛЛИЧЕСКИЙ СОЛЬВАТ ПРОИЗВОДНОГО (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТОЙ И СПОСОБ ЕГО ПОЛУЧЕНИЯ (CRYSTALLINE SOLVATE OF (1S)-1,5-ANHYDRO-L-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVE WITH AMINO ACID AND PROCESS FOR PREPARING THE SAME)
Estimated Expiration: ⤷ Subscribe

Patent: 5999
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА (CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Subscribe

Patent: 0900066
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ) -D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА
Estimated Expiration: ⤷ Subscribe

Patent: 1171333
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-С-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА
Estimated Expiration: ⤷ Subscribe

Patent: 1490902
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА
Estimated Expiration: ⤷ Subscribe

Patent: 1791254
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА
Estimated Expiration: ⤷ Subscribe

Patent: 2091391
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА
Estimated Expiration: ⤷ Subscribe

European Patent Office

Patent: 69374
Patent: SOLVATES CRISTALLINS DE DÉRIVÉS DE (1S)-1,5-ANHYDRO-1-C-(3-((PHÉNYL)MÉTHYL)PHÉNYL)-D-GLUCITOL AVEC DES ALCOHOLS EN TANT QU'INHIBITEURS DE SGLT2 POUR LE TRAITEMENT DU DIABÈTE (CRYSTALLINE SOLVATES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL) METHYL) PHENYL)-D-GLUCITOL DERIVATIVES WITH ALCOHOLS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Subscribe

Patent: 57918
Patent: Solvates cristallins et complexes de dérivés de (1S)-1,5-anhydro-1-C-((phényl)méthyl) phényl)-d-glucitol avec acides aminés en tant qu'inhibiteurs SGLT2 pour le traitement des diabètes (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl) methyl) phenyl)-d-glucitol derivatives with amino acids as SGLT2 inhibitors for the treatment of diabetes)
Estimated Expiration: ⤷ Subscribe

Patent: 45466
Patent: SOLVATE DE PROPYLENE GLYCOLE DE (2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ÉTHOXY-BENZYL)-PHÉNYL]-6-HYDROXYMÉTHYL-2-MÉTHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL EN TANT QU'INHIBITEURS DU SGLT2 POUR LE TRAITEMENT DU DIABÈTE ((2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ETHOXY-BENZYL)-PHENYL]-6-HYDROXYMETHYL-2-METHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL PROPYLENE GLYCOL SOLVATE AS SGT2 INHIBITOR FOR THE TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Subscribe

Patent: 63807
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT SOLVATE DE (S)-PROPYLENE GLYCOL DE (2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ÉTHOXY-BENZYL)-PHÉNYL]-6-HYDROXYMÉTHYL-2-MÉTHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL CRISTALLINE (PHARMACEUTICAL COMPOSITION COMPRISING CRYSTALLINE (2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ETHOXY-BENZYL)-PHENYL]-6-HYDROXYMETHYL-2-METHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL (S)-PROPYLENE GLYCOL SOLVATE)
Estimated Expiration: ⤷ Subscribe

Hong Kong

Patent: 27359
Patent: 用於治療糖尿病的抑製劑的 -脫水- 苯基甲基苯基 -葡萄糖醇衍生物與醇的結晶溶劑合物 (CRYSTALLINE SOLVATES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL) METHYL) PHENYL)- D-GLUCITOL DERIVATIVES WITH ALCOHOLS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES SGLT2 (1S)-15--1-C-(3 -(()))-D-)
Estimated Expiration: ⤷ Subscribe

Israel

Patent: 5882
Patent: צורות גבישיות של נגזרות של (1 s)-1, 5-אנהידרו-1- c -(3-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמיניות ושימוש בהן לטיפול בסכרת (Crystalline forms of (1s)-1,5-anhydro-1-c-(3-(phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids and use thereof for the treatment of diabetes)
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Patent: 4180
Patent: סולבטים גבישיים וקומפלקסים של נגזרות של (s1) -1, 5 אנהידרו- 1 - c - ( 3- ((פניל(מתיל(פניל)-d- גלוציטול עם חומצות אמינו המשמשים כמעכבי sglt2 עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes)
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Patent: 4181
Patent: סולבטים גבישיים וקומפלקסים של נגזרות -1,51)(s-אנהידרו(3--1-c-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמינו המשמשים כמעכבי 2sglt עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes)
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Patent: 4182
Patent: סולבטים גבישיים וקומפלקסים של נגזרות 1s))-5,1-אנהידרו-1-c-(3-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמינו המשמשים כמעכבי 2sglt עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes)
Estimated Expiration: ⤷ Subscribe

Japan

Patent: 13889
Estimated Expiration: ⤷ Subscribe

Patent: 66651
Estimated Expiration: ⤷ Subscribe

Patent: 37187
Estimated Expiration: ⤷ Subscribe

Patent: 09545525
Estimated Expiration: ⤷ Subscribe

Patent: 13209394
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR TREATMENT OF DIABETES
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Patent: 15071636
Patent: 糖尿病の治療用ＳＧＬＴ２阻害剤としてのアミノ酸を有する（１Ｓ）−１，５−アンヒドロ−１−Ｃ−（３−（（フェニル）メチル）フェニル）−Ｄ−グルシトール誘導体の結晶性溶媒和物および複合体 (CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR TREATMENT OF DIABETES)
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Patent: 16172758
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Patent: 19059779
Patent: 糖尿病の治療用ＳＧＬＴ２阻害剤としてのアミノ酸を有する（１Ｓ）−１，５−アンヒドロ−１−Ｃ−（３−（（フェニル）メチル）フェニル）−Ｄ−グルシトール誘導体の結晶性溶媒和物および複合体 (CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES HAVING AMINO ACIDS AS SGLT2 INHIBITORS FOR TREATING DIABETES)
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Malaysia

Patent: 8566
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5- ANHYDRO-1 -C-(3-( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
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Patent: 3930
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (IS)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
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Mexico

Patent: 9143
Patent: SOLVATOS Y COMPLEJOS CRISTALINOS DE LOS DERIVADOS DE (1S)-1,5-ANHIDRO-1-C-(3-((FENIL)METIL)FENIL)-D-GLUCITOL CON AMINOACIDOS COMO INHIBIDORES DE SGLT2 PARA EL TRATAMIENTO DE LA DIABETES. (CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-L-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES.)
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Patent: 7155
Patent: SOLVATOS Y COMPLEJOS CRISTALINOS DE LOS DERIVADOS DE (1S)-1, 5-ANHIDRO-1-C- (3-((FENIL) METIL) FENIL) -D-GLUCITOL CON AMINOÁCIDOS COMO INHIBIDORES DE SGLT2 PARA EL TRATAMIENTO DE LA DIABETES. (CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-L-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES.)
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Patent: 08015377
Patent: SOLVATOS Y COMPLEJOS CRISTALINOS DE LOS DERIVADOS DE (1S) - 1,5-ANHIDRO-1-C-(3-((FENIL)METIL)FENIL)-D-GLUCITOL CON AMINOACIDOS COMO INHIBIDORES DE SGLT2 PARA EL TRATAMIENTO DE LA DIABETES. (CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-L-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES.)
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New Zealand

Patent: 4346
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-L-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
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Patent: 9190
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL) METHYL) PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
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Patent: 9195
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL) METHYL) PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
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Patent: 9202
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL) METHYL) PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
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Norway

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Patent: 221233
Patent: Krystallinske solvater og komplekser av (1S)-1,5-anhydro-1-C-(3-((fenyl)metyl)fenyl)-D-glucitol-derivater med aminosyrer som SGLT2-inhibitorer for behandling av diabetes
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Peru

Patent: 080349
Patent: ESTRUCTURAS DE CRISTAL DE INHIBIDORES SGLT2 Y PROCESOS PARA PREPARAR LOS MISMOS
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Patent: 120776
Patent: ESTRUCTURAS CRISTALINAS DE DAPAGLIFLOZIN Y SUS PROCESOS DE PREPARACION
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Philippines

Patent: 012500168
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (IS)-1,5-ANHYDRO-L-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
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Poland

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Portugal

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Serbia

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Patent: KRISTALNI SOLVATI DERIVATA (1S)-1,5-ANHIDRO-1-C-(3-((FENIL) METIL) FENIL)-D-GLUCITOLA SA ALKOHOLIMA KAO INHIBITORI SGLT2 ZA TRETMAN DIJABETESA (CRYSTALLINE SOLVATES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL) METHYL) PHENYL)-D-GLUCITOL DERIVATIVES WITH ALCOHOLS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
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Patent: 2741
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (1S) -1, 5-ANHYDRO-1-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
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Patent: 201402181S
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (1S) -1, 5-ANHYDRO-1-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
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Slovenia

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South Africa

Patent: 0810475
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (IS)-1,5-ANHYDRO-L-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
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South Korea

Patent: 1493102
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Patent: 090023643
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
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Patent: 0811127
Patent: Crystal structures of SGLT2 inhibitors and processes for preparing same
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Patent: Crystal structures of SGLT2 inhibitors and processes for preparing same
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Ukraine

Patent: 765
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (IS)-1,5-АНГИДРО-L-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ КАК ИНГИБИТОРЫ БЕЛКА SGLT2, ПРИГОДНЫЕ В ЛЕЧЕНИИ ДИАБЕТА;КРИСТАЛІЧНІ СОЛЬВАТИ І КОМПЛЕКСИ ПОХІДНИХ (IS)-1,5-АНГІДРО-L-C-(3-((ФЕНІЛ)МЕТИЛ)ФЕНІЛ)-D-ГЛЮЦИТОЛУ З АМІНОКИСЛОТАМИ ЯК ІНГІБІТОРИ БІЛКА SGLT2, ПРИДАТНІ У ЛІКУВАННІ ДІАБЕТУ (CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-L-C- (3- ((PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
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See the table below for additional patents covering FARXIGA around the world.

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Country	Patent Number	Title	Estimated Expiration
Canada	2356331	METHODES DE SUPPRESSION DU GLUCAGON (METHODS FOR GLUCAGON SUPPRESSION)	⤷ Subscribe
Serbia	53638	KRISTALNI SOLVATI DERIVATA (1S)-1,5-ANHIDRO-1-C-(3-((FENIL) METIL) FENIL)-D-GLUCITOLA SA ALKOHOLIMA KAO INHIBITORI SGLT2 ZA TRETMAN DIJABETESA (CRYSTALLINE SOLVATES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL) METHYL) PHENYL)-D-GLUCITOL DERIVATIVES WITH ALCOHOLS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2021037400		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FARXIGA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	2013/013	Ireland	⤷ Subscribe	PRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1734971	91989	Luxembourg	⤷ Subscribe	91989, EXPIRES: 20260617
1506211	132014902277722	Italy	⤷ Subscribe	PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

FARXIGA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FARXIGA

Introduction

FARXIGA, also known as dapagliflozin, is a groundbreaking SGLT2 inhibitor developed by AstraZeneca. It has made significant strides in the treatment of Type 2 diabetes, heart failure, and chronic kidney disease. Here, we delve into the market dynamics and financial trajectory of FARXIGA, highlighting its impact, growth, and future prospects.

Market Significance of FARXIGA

FARXIGA has emerged as a pivotal drug in managing heart and kidney health. Its mechanism of action, which involves inhibiting the sodium-glucose cotransporter 2 (SGLT2), has shown efficacy in reducing blood sugar levels, as well as in treating heart failure and chronic kidney disease[1][5].

Indications and Market Share

FARXIGA has secured approvals for multiple indications, including Type 2 diabetes, heart failure with reduced ejection fraction, and chronic kidney disease (CKD) regardless of diabetic status. This broad range of approvals has enabled the drug to capture a significant market share. In markets where FARXIGA has been launched for CKD, it has secured between 70% and 90% of the market share[1].

Competitive Landscape

The SGLT2 inhibitor market is competitive, with other notable drugs like Jardiance (empagliflozin) from Eli Lilly and Boehringer Ingelheim. However, FARXIGA's early-to-market advantage in several territories and its comprehensive approval profile have given it a strong foothold. For instance, in the U.S. heart failure market, FARXIGA and Jardiance are currently splitting the market roughly 50-50, though FARXIGA leads in several ex-U.S. territories[1].

Financial Performance of FARXIGA

Quarterly and Annual Sales

In the first quarter of 2022, FARXIGA achieved a milestone by reaching $1 billion in quarterly sales, a 67% year-over-year increase that exceeded Wall Street's expectations by 20%. This performance was driven by strong demand across its indications[1].

For the full year 2023, AstraZeneca reported significant revenue growth, with FARXIGA contributing substantially to the company's cardiovascular, renal, and metabolism (CVRM) segment. The CVRM segment saw a 18% increase in revenue, with FARXIGA specifically growing by 36%[3].

Revenue Contribution

FARXIGA's revenue has been a key driver for AstraZeneca's overall financial performance. In 2023, the drug's sales contributed to the company's total revenue of $45.811 billion, which was up 6% despite a decline in COVID-19 related revenues[2][3].

Regulatory Milestones and Developmental Activities

Recent Approvals and Trials

FARXIGA has recently received FDA approval for treating heart failure patients with reduced ejection fraction and is awaiting results from the phase 3 Deliver trial, which could expand its indication to heart failure with preserved ejection fraction. Additionally, it has been approved for CKD patients regardless of their diabetic status, a broader approval compared to its competitor Invokana[1].

Future Prospects in Myocardial Infarction

Research is ongoing to explore FARXIGA's potential in treating myocardial infarction. The DAPA-MI Phase III trial is a pivotal study in this area, and the drug's mechanism of action is being extensively analyzed for its effectiveness in this new indication. This could significantly expand FARXIGA's market potential through 2032[5].

Market Forecast and Growth Projections

Sales Projections

The market forecast for FARXIGA is optimistic, with the drug expected to continue its growth trajectory. The "FARXIGA Market Size, Forecast, and Emerging Insight - 2032" report by ResearchAndMarkets.com provides a detailed analysis of the drug's market potential, including its projected sales and market share in the treatment of myocardial infarction and other indications[5].

Competitive Analysis

The report also offers a comprehensive SWOT analysis and an overview of the competitive landscape, highlighting both established and emerging therapies in the myocardial infarction treatment market. This analysis suggests that FARXIGA is well-positioned to maintain its market dominance and potentially expand its reach into new therapeutic areas[5].

Financial Impact on AstraZeneca

Revenue Growth

FARXIGA's success has been a significant contributor to AstraZeneca's revenue growth. In the first half of 2024, AstraZeneca reported an 18% increase in total revenue, driven largely by the performance of FARXIGA and other key medicines in the CVRM and oncology segments[4].

Segment Performance

The CVRM segment, which includes FARXIGA, saw a 22% growth in revenue in the first half of 2024. This growth, combined with strong performances in oncology, respiratory and immunology, and rare diseases, has solidified AstraZeneca's financial position despite declines in COVID-19 related revenues[4].

Key Takeaways

Market Dominance: FARXIGA has established itself as a leading SGLT2 inhibitor, capturing significant market share in its approved indications.
Financial Performance: The drug has contributed substantially to AstraZeneca's revenue growth, achieving $1 billion in quarterly sales and driving the CVRM segment's growth.
Regulatory Milestones: FARXIGA has secured broad approvals and is undergoing clinical trials for new indications, including myocardial infarction.
Growth Projections: The drug is forecasted to continue its growth trajectory, with significant potential in new therapeutic areas.
Competitive Landscape: FARXIGA remains competitive against other SGLT2 inhibitors, with a strong market position and ongoing research to expand its indications.

FAQs

What are the primary indications for FARXIGA?

FARXIGA is primarily indicated for the treatment of Type 2 diabetes, heart failure with reduced ejection fraction, and chronic kidney disease (CKD) regardless of diabetic status.

How has FARXIGA performed financially?

FARXIGA achieved $1 billion in quarterly sales in the first quarter of 2022 and has continued to drive revenue growth for AstraZeneca, contributing significantly to the company's CVRM segment.

What are the future prospects for FARXIGA in myocardial infarction treatment?

Research is ongoing, including the DAPA-MI Phase III trial, to explore FARXIGA's potential in treating myocardial infarction. This could significantly expand the drug's market potential through 2032.

How does FARXIGA compare to its competitors in the SGLT2 inhibitor market?

FARXIGA competes with other SGLT2 inhibitors like Jardiance but has secured a strong market position due to its broad approval profile and early-to-market advantage in several territories.

What is the projected market growth for FARXIGA?

The market forecast for FARXIGA is optimistic, with the drug expected to continue its growth trajectory, driven by its existing indications and potential new applications, including myocardial infarction treatment.

Sources

FiercePharma: AstraZeneca's Farxiga hits $1B quarterly mark, but flagship oncology ...
BioSpace: AstraZeneca Full year and Q4 2023 Financial Results
AstraZeneca: Full-year and Q4 2023 results announcement
Business Wire: AstraZeneca's H1 and Q2 2024 Financial Results
ResearchAndMarkets.com: FARXIGA Market Size, Forecast, and Emerging Insight - 2032

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FARXIGA Market Analysis and Financial Projection Experimental

Introduction

Market Significance of FARXIGA

Indications and Market Share

Competitive Landscape

Financial Performance of FARXIGA

Quarterly and Annual Sales

Revenue Contribution

Regulatory Milestones and Developmental Activities

Recent Approvals and Trials

Future Prospects in Myocardial Infarction

Market Forecast and Growth Projections

Sales Projections

Competitive Analysis

Financial Impact on AstraZeneca

Revenue Growth

Segment Performance

Key Takeaways

FAQs

What are the primary indications for FARXIGA?

How has FARXIGA performed financially?

What are the future prospects for FARXIGA in myocardial infarction treatment?

How does FARXIGA compare to its competitors in the SGLT2 inhibitor market?

What is the projected market growth for FARXIGA?

Sources

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