XIGDUO XR Drug Patent Profile

When do Xigduo Xr patents expire, 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

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.

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	205649-002	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	205649-001	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	205649-003	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
Luxembourg	92182
Taiwan	I466876
China	1896088	C-aryl glucoside sglt2 inhibitors
New Zealand	536605	C-aryl glucoside inhibitors of sodium dependent glucose transporters found in the intestine and kidney (SGLT2)
Cyprus	1126112
Mexico	2008015377
Japan	2016104753	別の抗糖尿病薬を用いた先の治療に抵抗性を有する２型糖尿病患者をＳＧＬＴ２阻害剤およびその組成物を用いて治療する方法 (METHODS FOR TREATING TYPE 2 DIABETES IN PATIENTS RESISTANT TO PREVIOUS TREATMENT WITH OTHER ANTI-DIABETIC DRUGS EMPLOYING SGLT2 INHIBITOR AND COMPOSITIONS THEREOF)

Supplementary Protection Certificates for XIGDUO XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C01506211/02	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
2139494	C202030045	Spain		PRODUCT NAME: SAXAGLIPTINA + DAPAGLIFOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1108; DATE OF AUTHORISATION: 20160715; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1108; DATE OF FIRST AUTHORISATION IN EEA: 20160715
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	132020000000115	Italy		PRODUCT NAME: SAXAGLIPTIN E DAPAGLIFLOZIN(QTERN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1108, 20160719
2498758	2090013-0	Sweden		PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113
2139494	2090034-6	Sweden		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE; REG. NO/DATE: EU/1/16/1108 20160719
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 [...]

Market Dynamics and Financial Trajectory for XIGDUO XR

Last updated: December 30, 2025

Summary

XIGDUO XR (dapagliflozin/metformin extended-release) is a combination oral antidiabetic medication approved for managing type 2 diabetes mellitus (T2DM). Launched by AstraZeneca in 2019, the drug targets a growing global diabetic population, leveraging the increasing adoption of SGLT2 inhibitors and metformin-based therapies. This report provides a comprehensive analysis of its market dynamics and financial outlook, emphasizing sales drivers, competitive landscape, regulatory factors, and future growth prospects.

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What Are the Key Market Drivers for XIGDUO XR?

1. Rising Prevalence of Type 2 Diabetes Mellitus

The global T2DM prevalence was estimated at 537 million in 2021 and projected to reach 643 million by 2030 (IDF, 2022). This demographic shift fuels demand for effective, tolerable, and convenient antidiabetic therapies.

2. Shift Toward Fixed-Dose Combinations (FDCs)

Patients and clinicians favor fixed-dose combinations to improve adherence, simplify regimens, and reduce pill burden. XIGDUO XR's extended-release formulation offers once-daily dosing, aligning with this trend.

3. Expanding SGLT2 Inhibitor Market

SGLT2 inhibitors, including dapagliflozin, have established a reputation for cardiovascular and renal benefits. Their inclusion in combination therapies widens market appeal, especially in high-risk patient groups (Neal et al., NEJM, 2019).

4. Preference for Metformin-Based Therapies

Metformin remains the first-line treatment globally. Combining it with SGLT2 inhibitors like dapagliflozin enhances glycemic control and minimizes hypoglycemia risk, further consolidating market demand.

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What Are the Market Challenges Facing XIGDUO XR?

1. Competitive Landscape of Antidiabetic Combinations

XIGDUO XR faces stiff competition from other FDCs such as:

Competitor	Active Ingredients	Launch Year	Manufacturer
Jardiance (empagliflozin/metformin ER)	Empagliflozin/Metformin	2017	Boehringer Ingelheim / Lilly
Invokana (canagliflozin/metformin)	Canagliflozin/Metformin	2017	Janssen
Synjardy (empagliflozin/metformin)	Empagliflozin/Metformin	2015	Boehringer Ingelheim

2. Regulatory and Reimbursement Barriers

Stringent approval processes across markets and evolving reimbursement policies challenge rapid uptake. The cost profile influences prescribing behavior, especially in cost-sensitive regions.

3. Patient and Provider Acceptance

Concerns over side effects like genitourinary infections and diabetic ketoacidosis limit adoption. Education on safety profile remains critical.

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Which Factors Influence XIGDUO XR’s Financial Trajectory?

1. Sales Performance Since Launch

Since its 2019 launch, XIGDUO XR has demonstrated notable growth. According to IQVIA (2022), U.S. sales in Q2 2022 reached approximately $100 million, signaling strong market reception.

Year	Approximate Global Sales (USD million)	Notes
2019	$35M	Launch year, initial uptake
2020	$70M	Accelerated growth
2021	$150M	Expansion into new markets
2022 (Q2)	$100M	Continued growth, market penetration

2. Geographic Market Penetration

• United States: Largest market; driven by healthcare infrastructure and high T2DM prevalence.
• Europe: Growing acceptance, though influenced by pricing and reimbursement constraints.
• Asia-Pacific: Rapidly expanding; countries like China and India represent high-growth potential due to escalating diabetes burden.

3. Pricing Strategies and Rebates

Pricing varies by region, with premium positioning in the U.S. (~$600/month retail) and discounts in cost-sensitive markets. Reimbursement negotiations significantly influence volume.

4. Pipeline and Portfolio Strategies

Integration into AstraZeneca’s broader diabetes portfolio, along with pipeline developments toward combination therapies with other novel agents, underpins sustained growth.

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How Does XIGDUO XR Compare to Competitors?

Attribute	XIGDUO XR	Jardiance in Met	Invokamet	Synjardy
Active Ingredients	Dapagliflozin + Metformin XR	Empagliflozin + Metformin XR	Canagliflozin + Metformin	Empagliflozin + Metformin
Dosing Frequency	Once daily	Once daily	Twice daily	Once daily
Release Profile	Extended-release	Extended-release	Immediate-release	Extended-release
Cardiovascular Benefits	Supported by dapagliflozin data	Supported by empagliflozin studies	Similar	Similar
Cost Price (USD/month)	~$600	~$580	~$600	~$610

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What Are the Future Market Outlooks?

Growth Projections

• The global SGLT2 inhibitor market (including combination products) is projected to reach $20.4 billion by 2027, with a CAGR of 10.1% from 2020–2027 (Global Market Insights, 2021).

Year	Projected Sales of XIGDUO XR (USD million)	Assumptions
2023	$180M	Continued adoption, new markets entering
2024	$220M	Increased formulary acceptance
2025	$290M	Expansion in Asia-Pacific and emerging markets
2027	~$400M	Sustained growth, novel indications

Key Opportunities

• Expansion into renal and cardiovascular indications based on dapagliflozin’s proven benefits.
• Inclusion in treatment guidelines for newer T2DM management protocols.
• Development of adjacent fixed-dose formulations tailored to specific patient populations.

Potential Risks

• Slower-than-expected adoption due to safety concerns or price sensitivity.
• Market saturation with competing combination products.
• Regulatory delays or unfavorable reimbursement policies.

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Conclusion: Market Dynamics and Investment Outlook

XIGDUO XR’s trajectory is shaped by the expanding global T2DM population, favorable regulatory trends for FDCs, and its positioning within the growing SGLT2 inhibitor segment. Strategic pricing, geographic expansion, and ongoing clinical evidence will be pivotal in translating these drivers into sustained revenue gains. While competition remains fierce, XIGDUO XR’s extended-release profile and proven efficacy offer a competitive edge in the context of evolving diabetes management paradigms.

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Key Takeaways

• The rising prevalence of T2DM worldwide underpins XIGDURO XR’s growth potential.
• Fixed-dose combination therapies are increasingly preferred, benefiting XIGDUO XR’s market penetration.
• Competition from other SGLT2 and metformin combination products necessitates aggressive market strategies.
• Sales are projected to reach $400 million globally by 2027, contingent on regulatory and reimbursement landscapes.
• Expansion into renal and cardiovascular indications presents significant upside.

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FAQs

1. How does XIGDUO XR differ from other SGLT2 inhibitor/metformin combinations?

XIGDUO XR uniquely offers an extended-release formulation of metformin, allowing once-daily dosing which improves adherence and tolerability. Its specific combination with dapagliflozin also capitalizes on proven cardiovascular benefits.

2. What are the primary safety concerns for XIGDUO XR?

Similar to other SGLT2 inhibitors, risks include genital infections, urinary tract infections, and rare cases of diabetic ketoacidosis. Proper patient selection and monitoring mitigate these risks.

3. How is reimbursement impacting XIGDUO XR’s adoption?

Reimbursement policies vary by region; in the US, favorable formulary placement has accelerated uptake. In cost-sensitive markets, high prices pose barriers which AstraZeneca seeks to address via strategic pricing and patient assistance programs.

4. What are the regulatory trends influencing XIGDUO XR’s markets?

Regulatory authorities increasingly favor approval pathways for combination therapies that demonstrate clinical benefit and safety. Recent approvals in emerging markets expand opportunities, though regional approval timelines vary.

5. What are the long-term growth prospects for XIGDUO XR?

With the expanding global diabetes burden, ongoing clinical advancements, and approval for additional indications, XIGDUO XR’s market is poised for sustained growth, provided it adapts to competitive pressures and policy shifts.

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References

1. International Diabetes Federation (IDF). Diabetes Atlas, 10th Edition, 2022.
2. Neal B, et al. Cardiovascular and renal outcomes with dapagliflozin in type 2 diabetes. NEJM, 2019.
3. Global Market Insights. SGLT2 inhibitor market report, 2021.
4. IQVIA. Pharmacy Claims Data, Q2 2022.