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XIGDUO XR Drug Patent Profile

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

Xigduo Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and thirty-six patent family members in forty-six countries.

The generic ingredient in XIGDUO XR is dapagliflozin; metformin hydrochloride. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Xigduo Xr

Xigduo Xr 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 May 12, 2031. This may change due to patent challenges or generic licensing.

There have been seven 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 is one tentative approval for the generic drug (dapagliflozin; metformin hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XIGDUO XR

International Patents:	236
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Patent Applications:	10
Drug Prices:	Drug price information for XIGDUO XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XIGDUO XR
DailyMed Link:	XIGDUO XR at DailyMed

See drug prices for XIGDUO XR

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

NDA:

205649

Dosage:

TABLET, EXTENDED RELEASE;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 XIGDUO XR

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

Sponsor	Phase
Beni-Suef University	Phase 3
University of Guadalajara	Phase 4
AstraZeneca	Phase 1

See all XIGDUO XR clinical trials

Pharmacology for XIGDUO XR

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

Paragraph IV (Patent) Challenges for XIGDUO XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XIGDUO XR	Extended-release Tablets	dapagliflozin; metformin hydrochloride	2.5 mg/1000 mg	205649	1	2018-10-29
XIGDUO XR	Extended-release Tablets	dapagliflozin; metformin hydrochloride	5 mg/500 mg 5 mg/1000 mg 10 mg/500 mg 10 mg/1000 mg	205649	10	2018-01-08

US Patents and Regulatory Information for XIGDUO XR

XIGDUO XR is protected by five US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No					Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014		RX	Yes	Yes
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No					Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No					Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017		RX	Yes	No					Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014		RX	Yes	No					Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014		RX	Yes	Yes					Y

Expired US Patents for XIGDUO XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014

International Patents for XIGDUO XR

When does loss-of-exclusivity occur for XIGDUO XR?

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

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Hungary

Japan

Lithuania

Mexico

Norway

Poland

Portugal

Russian Federation

Serbia

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XIGDUO XR around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2013209394	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
European Patent Office	2435033	MÉTHODES POUR LE TRAITEMENT DE DIABÈTE DE TYPE 2 CHEZ DES PATIENTS RÉSISTANT À UN TRAITEMENT PRÉCÉDENT AVEC D'AUTRES MÉDICAMENTS ANTI-DIABÉTIQUES EMPLOYANT UN INHIBITEUR SGLT2 ET COMPOSITIONS ASSOCIÉES (METHODS FOR TREATING TYPE 2 DIABETES IN PATIENTS RESISTANT TO PREVIOUS TREATMENT WITH OTHER ANTI-DIABETIC DRUGS EMPLOYING AN SGLT2 INHIBITOR AND COMPOSITIONS THEREOF)
New Zealand	536605	C-aryl glucoside inhibitors of sodium dependent glucose transporters found in the intestine and kidney (SGLT2)
Spain	2521665
Taiwan	I466876
European Patent Office	2139494	PRÉPARATIONS PHARMACEUTIQUES CONTENANT DE L'HYDRATE DE PROPYLÈNEGLYCOL DE DAPAGLIFLOZINE (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE)
Brazil	PI0311323	composto inibidor de c-aril glicosídeo sglt2, composição farmacêutica e combinação

Supplementary Protection Certificates for XIGDUO XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	132014902277722	Italy		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
2139494	301054	Netherlands		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719
1506211	18/2013	Austria		PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
2139494	122020000043	Germany		PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715
1506211	C 2013 012	Romania		PRODUCT NAME: DAPAGLIFLOZIN SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTUIA (2S, 3R, 4R, 5S, 6R)-2-[4-CLOR-3-(4-ETOXIBENZIL)FENIL]-6-(HIDROXIMETIL)TETRAHIDRO-2H-PIRAN-3,4,5-TRIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/795/001, RO EU/1/12/795/002, RO EU/1/12/795/003, RO EU/1/12/795/004, RO EU/1/12/795/005, RO EU/1/12/795/006, RO EU/1/12/795/007, RO EU/1/12/795/008, RO EU/1/12/795/009, RO EU/1/12/795/001/010; DATE OF NATIONAL AUTHORISATION: 20121112; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/795/001, EMEA EU/1/12/795/002, EMEA EU/1/12/795/003, EMEA EU/1/12/795/004, EMEA EU/1/12/795/005, EMEA EU/1/12/795/006, EMEA EU/1/12/795/007, EMEA EU/1/12/795/008 [...]
1506211	SPC/GB13/021	United Kingdom		PRODUCT NAME: DAPAGLIFLOZIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/12/795/001 20121114; UK EU/1/12/795/002 20121114; UK EU/1/12/795/003 20121114; UK EU/1/12/795/004 20121114; UK EU/1/12/795/005 20121114; UK EU/1/12/795/006 20121114; UK EU/1/12/795/007 20121114; UK EU/1/12/795/008 20121114; UK EU/1/12/795/009 20121114; UK EU/1/12/795/010 20121114
2139494	CA 2020 00035	Denmark		PRODUCT NAME: SAXAGLIPTIN OG DAPAGLIFLOZIN; REG. NO/DATE: EU/1/16/1108 20160719

XIGDUO XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XIGDUO XR

Introduction

XIGDUO XR, a once-daily fixed-dose combination of the SGLT2 inhibitor dapagliflozin (trade name FARXIGA) and metformin hydrochloride extended-release, has been a significant addition to the treatment options for adults with type 2 diabetes. Here, we will delve into the market dynamics and financial trajectory of XIGDUO XR, highlighting its approval, market performance, and financial impact on AstraZeneca.

Approval and Market Presence

XIGDUO XR was first approved by the US FDA in October 2014 for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus[1].

• US Approval: It is the first and only once-daily combination tablet of an SGLT2 inhibitor and metformin HCl extended-release approved in the United States.
• Global Expansion: In addition to the US, XIGDUO XR has been approved in other regions, including Australia and, more recently, China in June 2023[4].

Market Dynamics

Competitive Landscape

XIGDUO XR operates in a competitive diabetes treatment market, but its unique combination of dapagliflozin and metformin sets it apart.

• Unique Selling Proposition: The combination of an SGLT2 inhibitor and metformin provides a comprehensive approach to glycemic control, making it an attractive option for prescribers and patients.
• Patient Need: The prevalence of diabetes is projected to reach 783 million by 2045, with type 2 diabetes accounting for more than 90% of the overall population with diabetes in China. This significant unmet medical need drives the demand for effective treatments like XIGDUO XR[4].

Regulatory Environment

Regulatory approvals play a crucial role in the market dynamics of pharmaceutical products.

• China Approval: The approval by China’s National Medical Products Administration (NMPA) in June 2023 marked a significant milestone, making XIGDUO XR the only once-daily fixed-dose combination of an SGLT2 inhibitor and metformin hydrochloride extended release in China[4].

Financial Trajectory

Revenue Growth

XIGDUO XR has contributed to AstraZeneca's revenue growth, particularly in the context of the company's broader diabetes portfolio.

• Revenue Contribution: While specific revenue figures for XIGDUO XR are not isolated, the drug is part of AstraZeneca's growing diabetes franchise. For example, Farxiga (dapagliflozin), a key component of XIGDUO XR, saw revenues increase by 40% in the first half of 2023[2].
• Geographical Performance: The approval in China is expected to further boost revenue, given the large and growing diabetes market in the region. China's diabetes market is particularly significant, with type 2 diabetes accounting for more than 90% of the diabetes population[4].

Financial Performance of AstraZeneca

AstraZeneca's overall financial performance provides context for the impact of XIGDUO XR.

• Total Revenue: In the first half of 2023, AstraZeneca reported total revenue of $22,295 million, with a 16% increase excluding COVID-19 medicines. This growth is driven by strong performances in various therapeutic areas, including cardiovascular, renal, and metabolism (CVRM) where XIGDUO XR is categorized[2].
• Core EPS: The company's core earnings per share (EPS) increased by 21% to $4.07 in the first half of 2023, reflecting the positive impact of new launches and increased patient access to key medicines like XIGDUO XR[2].

Regional Performance

United States

In the US, XIGDUO XR has been a part of AstraZeneca's diabetes portfolio since its approval in 2014.

• Market Share: The unique combination of dapagliflozin and metformin has helped XIGDUO XR gain a significant market share in the US diabetes treatment market[1].

Emerging Markets

The approval in China and other emerging markets has opened up new revenue streams.

• China: The recent approval in China is expected to drive significant growth, given the large patient population and the drug's first-line treatment status[4].
• Ex-China Emerging Markets: AstraZeneca has seen strong growth in ex-China emerging markets, with a 28% increase in revenue in the first half of 2023, which could be partly attributed to the expansion of its diabetes portfolio[2].

Future Outlook

Growth Projections

AstraZeneca expects continued growth in its diabetes franchise, including XIGDUO XR.

• Revenue Growth: The company anticipates that total revenue from China will return to growth and increase by a low-to-mid single-digit percentage in FY 2023, partly driven by the approval and launch of XIGDUO XR[2][5].
• Market Expansion: The success of XIGDUO XR in new markets, combined with its established presence in existing markets, is expected to contribute to AstraZeneca's overall revenue growth.

Competitive and Regulatory Factors

The future success of XIGDUO XR will depend on various competitive and regulatory factors.

• Competition: The diabetes treatment market is highly competitive, with numerous drugs and combinations available. XIGDUO XR's unique mechanism and clinical evidence will be crucial in maintaining its market position.
• Regulatory Environment: Continued regulatory approvals and favorable reimbursement policies will be essential for the drug's long-term success.

Key Takeaways

• Unique Combination: XIGDUO XR offers a unique combination of dapagliflozin and metformin, setting it apart in the diabetes treatment market.
• Global Approvals: The drug has been approved in several regions, including the US and China, expanding its market reach.
• Revenue Contribution: XIGDUO XR contributes to AstraZeneca's growing revenue in the diabetes segment.
• Future Growth: The drug is expected to drive growth in emerging markets, particularly in China, and maintain its market share in established markets.

FAQs

Q: What is XIGDUO XR, and how does it work? A: XIGDUO XR is a once-daily fixed-dose combination of the SGLT2 inhibitor dapagliflozin and metformin hydrochloride extended-release. It works by combining two anti-hyperglycemic agents with complementary mechanisms of action to improve glycemic control in adults with type 2 diabetes.

Q: Where is XIGDUO XR approved? A: XIGDUO XR is approved in the US, Australia, China, and other regions for the treatment of adults with type 2 diabetes.

Q: How has XIGDUO XR impacted AstraZeneca's revenue? A: XIGDUO XR has contributed to AstraZeneca's revenue growth, particularly in the diabetes segment, with Farxiga (dapagliflozin) seeing a 40% revenue increase in the first half of 2023.

Q: What are the future growth prospects for XIGDUO XR? A: XIGDUO XR is expected to drive growth in emerging markets, especially in China, and maintain its market share in established markets, contributing to AstraZeneca's overall revenue growth.

Q: What are the key competitive advantages of XIGDUO XR? A: The unique combination of dapagliflozin and metformin, along with its once-daily dosing and comprehensive approach to glycemic control, sets XIGDUO XR apart in the competitive diabetes treatment market.

Sources

1. AstraZeneca Press Release: "US FDA approves once-daily XIGDUO™ XR tablets for adults with type 2 diabetes" (October 30, 2014).
2. AstraZeneca H1 and Q2 2023 Results: "Strong revenue and EPS growth" (July 28, 2023).
3. AstraZeneca Debt Investor Update: "H1 and Q2 2023 Results" (July 28, 2023).
4. AstraZeneca Press Release: "Xigduo XR approved in China for adults with type-2 diabetes" (June 27, 2023).
5. AstraZeneca Full Year and Q4 2022 Results: "Product Sales increased by 13% (19% at CER)" (February 9, 2023).