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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

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	205649-001	Oct 29, 2014
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017

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
Mexico	2008015377	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.)
World Intellectual Property Organization (WIPO)	2008116179
Japan	2015110630	二層錠製剤 (BILAYER TABLET FORMULATIONS)
South Africa	200409295	C-aryl glucoside SGLT2 inhibitors and method.
Eurasian Patent Organization	202091391	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

Supplementary Protection Certificates for XIGDUO XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	PA 2013 008, C 1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211	C20130006 00074	Estonia		PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
1506211	179 5017-2014	Slovakia		PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
1506211	C300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121

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).