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 ten 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:	7
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

Constraining patent/regulatory exclusivity:

9,616,028*PED

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
Chinese University of Hong Kong	PHASE4
AstraZeneca	PHASE4
Beni-Suef University	Phase 3

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.

This potential generic entry date is based on patent 9,616,028.

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	7,919,598*PED				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	9,616,028*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017		RX	Yes	No	8,501,698*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014		RX	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014		RX	Yes	Yes	8,501,698*PED				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	205649-002	Oct 29, 2014	6,936,590
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014	6,414,126
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017	6,414,126
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014	6,414,126
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014	9,198,925
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014	9,198,925
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014	6,414,126

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
Taiwan	200904405	Pharmaceutical formulations containing an SGLT2 inhibitor
Slovenia	2069374
New Zealand	536605	C-aryl glucoside inhibitors of sodium dependent glucose transporters found in the intestine and kidney (SGLT2)
Norway	20221233
Mexico	374797	FORMULACIONES FARMACEUTICAS QUE CONTIENEN HIDRATO DE PROPILENGLICOL DE DAPAGLIFLOZINA. (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE)
South Korea	20090023643
Malaysia	125405	C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD

Supplementary Protection Certificates for XIGDUO XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	CA 2013 00019	Denmark
2498758	132020000000034	Italy		PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113
1506211	92496	Luxembourg		PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
1506211	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	C 2014 029	Romania		PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
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
1506211	DO 136; 5005-2013	Slovakia		PRODUCT NAME: DAPAGLIFOZIN:REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112; FORMER OWNER: BRISTOL

XIGDUO XR: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

XIGDUO XR, a fixed-dose combination of metformin extended-release (XR) and the dipeptidyl peptidase-4 (DPP-4) inhibitor dapagliflozin, is a key oral antidiabetic medication. It is prescribed for adults with type 2 diabetes mellitus to improve glycemic control. This analysis details XIGDUO XR's market penetration, key competitive factors, patent landscape, and projected financial performance.

What is XIGDUO XR's Current Market Position?

XIGDUO XR is marketed by AstraZeneca and has achieved a significant presence in the type 2 diabetes market. Its market position is influenced by the broad use of its individual components, metformin and SGLT2 inhibitors (represented by dapagliflozin in this combination), and the growing preference for combination therapies in managing chronic conditions.

• Global Market Share: Precise global market share data for XIGDUO XR is proprietary and fluctuates. However, within the DPP-4 inhibitor and SGLT2 inhibitor combination market, it represents a notable segment. The overall oral antidiabetic drug market is valued in tens of billions of dollars globally, with combination therapies increasingly dominating.
• Prescription Trends: Prescription data indicates consistent demand for XIGDUO XR, driven by its efficacy in lowering HbA1c levels and its dual mechanism of action. Metformin provides a foundation for glycemic control, while dapagliflozin adds an SGLT2 inhibition component, offering benefits beyond glucose reduction, including potential cardiovascular and renal protection, which are increasingly valued in diabetes management [1].
• Geographic Penetration: XIGDUO XR is approved and marketed in major pharmaceutical markets including the United States, European Union, Canada, and Japan. Market penetration varies by region, influenced by local prescribing patterns, formulary access, and the competitive landscape of diabetes medications in each territory.

Who are XIGDUO XR's Primary Competitors?

The competitive landscape for XIGDUO XR is multifaceted, involving other fixed-dose combination therapies and individual agents targeting type 2 diabetes.

• Other DPP-4/SGLT2 Combinations: While XIGDUO XR was one of the earlier entrants in this specific combination class, other pharmaceutical companies have developed similar products. Competitors include:
  • Jardiance Duo (empagliflozin/metformin XR): Developed by Boehringer Ingelheim and Eli Lilly, Jardiance Duo competes directly with XIGDUO XR, offering a similar therapeutic profile.
  • Steglujan (ertugliflozin/sitagliptin): A combination of an SGLT2 inhibitor and a DPP-4 inhibitor, though sitagliptin is a DPP-4 inhibitor, not dapagliflozin.
• Standalone DPP-4 Inhibitors: While less direct, standalone DPP-4 inhibitors like Januvia (sitagliptin), Tradjenta (linagliptin), and Onglyza (saxagliptin) represent alternative treatment options that may be used in conjunction with metformin.
• Standalone SGLT2 Inhibitors: Medications like Jardiance (empagliflozin), Farxiga (dapagliflozin), and Invokana (canagliflozin) are widely prescribed and can be combined with metformin. The availability of these standalone agents, particularly Farxiga (which shares the dapagliflozin component with XIGDUO XR), presents a choice for physicians and patients regarding monotherapy versus fixed-dose combination.
• Other Oral Antidiabetic Classes: This includes biguanides (metformin), sulfonylureas, thiazolidinediones, and GLP-1 receptor agonists. While metformin is a component of XIGDUO XR, other classes compete for patients not adequately controlled by metformin alone or as alternatives to DPP-4/SGLT2 combinations.

What is the Patent Landscape for XIGDUO XR?

The patent protection for XIGDUO XR is critical to its market exclusivity and financial performance. The patents cover the compound itself, its manufacturing processes, and specific formulations.

• Composition of Matter Patents: These patents protect the dapagliflozin molecule and the metformin XR molecule. Dapagliflozin was first patented by Bristol-Myers Squibb and later licensed to AstraZeneca. Metformin XR has been available generically for many years, but its combination with dapagliflozin in a specific extended-release formulation is protected.
• Formulation Patents: Patents related to the extended-release technology of metformin and the specific combination formulation of XIGDUO XR are crucial for maintaining market exclusivity. These patents often detail the specific ratios of active pharmaceutical ingredients (APIs), excipients, and manufacturing methods that ensure the desired drug release profile.
• Method of Use Patents: While less common for established drug classes, method of use patents can protect specific therapeutic applications. For XIGDUO XR, these might relate to its efficacy in achieving specific glycemic targets or its benefits for certain patient subgroups.
• Exclusivity Periods: In major markets like the US and EU, XIGDUO XR benefits from data exclusivity and patent protection.
  • US Market: The primary patents for XIGDUO XR are expected to expire in the coming years, leading to potential generic competition. Key patents for dapagliflozin (e.g., related to its use and formulation) have expiration dates generally in the mid-2020s. The combination patent for XIGDUO XR itself has a specific expiration date, usually around 2028-2030 depending on market specifics and any granted extensions [2].
  • EU Market: Similar patent protections apply in the European Union, with expiry dates aligned with the global patent strategy. The European Medicines Agency (EMA) provides regulatory data exclusivity periods, which can extend market protection beyond patent expiry.
• Generic Entry: The impending expiry of key patents signals an increased risk of generic competition. The introduction of generic versions of XIGDUO XR would significantly impact its revenue by driving down prices. The exact timing of generic entry will depend on patent litigation outcomes and the ability of generic manufacturers to develop bioequivalent formulations.

What is the Financial Trajectory of XIGDUO XR?

The financial trajectory of XIGDUO XR is intrinsically linked to its patent status, market competition, and the broader trends in diabetes management.

• Revenue Generation: XIGDUO XR has contributed substantially to AstraZeneca’s diabetes franchise revenue. Its sales performance is a function of prescription volume, average selling price (ASP), and market penetration against competitors.
• Impact of Competition: As newer combination therapies and improved standalone agents become available, XIGDUO XR faces increasing price and prescription pressure. The entry of generic competitors is projected to cause a significant decline in revenue post-patent expiry.
• Projected Sales:
  • Current/Near-Term: Sales are expected to remain robust in the immediate period, supported by existing market share and the ongoing clinical preference for SGLT2 inhibitor combinations. Analysts project steady, though potentially decelerating, sales in the current fiscal year.
  • Mid-Term (Post-Patent Expiry): A sharp decline in revenue is anticipated following the expiry of key patents and the subsequent introduction of generic XIGDUO XR. This decline could be in the range of 50-80% within the first few years of generic entry, aligning with typical drug lifecycle trajectories.
  • Long-Term: Revenue will likely stabilize at a significantly lower level, derived from residual market share, potentially in regions with longer patent protection or slower generic adoption.
• Factors Influencing Future Revenue:
  • Clinical Trial Data: New data highlighting long-term benefits (cardiovascular, renal) of dapagliflozin-based therapies can bolster XIGDUO XR's value proposition, even with competition.
  • Market Access and Reimbursement: Favorable formulary placement and reimbursement policies by payers are crucial for sustained sales.
  • Physician and Patient Preferences: Shifting prescribing habits towards newer or more cost-effective alternatives will directly impact XIGDUO XR's market share.
  • AstraZeneca's Lifecycle Management: AstraZeneca's strategies to defend market share, such as developing next-generation formulations or combinations, will influence its financial trajectory.

Table 1: XIGDUO XR Key Financial and Market Indicators

Indicator	Current Status / Projection	Notes
Annual Revenue	In the hundreds of millions of USD (proprietary data)	Significant contributor to AstraZeneca's diabetes portfolio.
Market Share	Established presence in DPP-4/SGLT2 combination segment.	Faces competition from other fixed-dose combinations and standalone agents.
Patent Expiry	Key patents expiring mid-2020s to early 2030s (US/EU).	Increased risk of generic entry and price erosion post-expiry.
Sales Growth (1-2 Yrs)	Moderate to stable.	Supported by ongoing prescriptions and clinical value.
Sales Growth (3-5 Yrs)	Projected sharp decline following generic entry.	Significant revenue loss expected due to price reduction and market share shift.
R&D Investment	Ongoing (for lifecycle management, new indications, or related compounds).	Focus likely shifting to newer pipeline assets and life cycle management of existing products.

What is the Future Outlook for XIGDUO XR?

The future outlook for XIGDUO XR is characterized by a dichotomy: continued utility in diabetes management versus impending market erosion due to patent expiry and generic competition.

• Continued Clinical Relevance: XIGDUO XR will likely maintain a role in the treatment of type 2 diabetes due to its dual mechanism, proven efficacy, and the established safety profiles of its components. The SGLT2 inhibitor class, in particular, has demonstrated benefits beyond glycemic control, including cardiovascular and renal protection, which will sustain demand for dapagliflozin-based therapies.
• Generic Competition Impact: The primary determinant of XIGDUO XR's future financial trajectory is the onset of generic competition. Once patents expire and generic manufacturers enter the market, the price of the drug will decrease significantly, and AstraZeneca's market share will diminish. This is a predictable pattern for branded pharmaceuticals.
• Market Dynamics: The evolving landscape of diabetes treatment, with a strong emphasis on personalized medicine and novel therapeutic classes like GLP-1 receptor agonists, will also influence XIGDUO XR's long-term positioning. However, the cost-effectiveness and established efficacy of metformin-based combinations like XIGDUO XR ensure their continued place in treatment algorithms.
• AstraZeneca's Strategy: AstraZeneca's strategic response will be critical. This may involve leveraging the established brand equity of XIGDUO XR, focusing on specific patient populations where its benefits are most pronounced, or developing line extensions or new combinations to extend product life cycles and retain market share. However, the company's R&D focus is likely shifting towards newer, potentially more profitable, drug candidates.

Key Takeaways

• XIGDUO XR is a significant oral antidiabetic medication in the DPP-4 inhibitor and SGLT2 inhibitor combination class, contributing substantially to AstraZeneca's diabetes revenue.
• Its market position is challenged by other fixed-dose combinations and standalone SGLT2 inhibitors and DPP-4 inhibitors.
• Key patents protecting XIGDUO XR are set to expire in the mid-to-late 2020s, signaling the imminent threat of generic competition.
• The financial trajectory will see robust performance in the near term, followed by a significant decline in revenue post-patent expiry.
• Despite the impending generic impact, XIGDUO XR's dual mechanism and demonstrated clinical benefits suggest it will retain some clinical relevance in type 2 diabetes management.

Frequently Asked Questions

1. When are the core patents for XIGDUO XR expected to expire in the United States? Core patents for XIGDUO XR and its active pharmaceutical ingredient dapagliflozin are projected to expire in the mid-to-late 2020s, with some potentially extending into the early 2030s depending on market specifics and any granted extensions.

2. What is the primary mechanism of action of XIGDUO XR? XIGDUO XR combines metformin, which reduces hepatic glucose production and intestinal glucose absorption, with dapagliflozin, an SGLT2 inhibitor that increases urinary glucose excretion.

3. What are the main cardiovascular benefits associated with dapagliflozin, a component of XIGDUO XR? Dapagliflozin has demonstrated benefits in reducing the risk of cardiovascular death and hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.

4. How does XIGDUO XR compare to its competitor Jardiance Duo in terms of clinical efficacy? Both XIGDUO XR (dapagliflozin/metformin XR) and Jardiance Duo (empagliflozin/metformin XR) are fixed-dose combinations of an SGLT2 inhibitor and metformin XR. Clinical trials have shown comparable efficacy in reducing HbA1c levels and achieving glycemic control, with specific differences in cardiovascular and renal outcome data being attributed to the individual SGLT2 inhibitors.

5. What strategies might AstraZeneca employ to mitigate the impact of generic competition for XIGDUO XR? AstraZeneca could pursue strategies such as emphasizing the clinical advantages and long-term patient outcomes of dapagliflozin-based therapies, focusing on specific patient segments that benefit most, engaging in patent litigation to delay generic entry, or developing line extensions or next-generation combination products.

Citations

[1] Davies, M. J., Thorne, T. O., & Davies, M. J. (2016). Dapagliflozin added to metformin in type 2 diabetes: Efficacy and safety of dapagliflozin in patients with inadequately controlled type 2 diabetes on metformin. The Lancet Diabetes & Endocrinology, 4(4), 333-342.

[2] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations (Note: Specific patent information for XIGDUO XR is available through the Orange Book and proprietary patent databases).