Dapagliflozin - Generic Drug Details

What are the generic sources for dapagliflozin and what is the scope of freedom to operate?

Dapagliflozin is the generic ingredient in seven branded drugs marketed by Aizant, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Biocon Pharma, Cipla, Inventia, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, MSN, Sandoz, Teva Pharms Usa, Zydus Pharms, Astrazeneca Ab, Cipla Ltd, Sun Pharm, Teva Pharms Usa Inc, and Torrent, and is included in thirty-one NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin has four hundred and twenty-five patent family members in fifty-two countries.

There are twenty-six drug master file entries for dapagliflozin. Twenty-two suppliers are listed for this compound. There are thirteen tentative approvals for this compound.

Summary for dapagliflozin

International Patents:	425
US Patents:	18
Tradenames:	7
Applicants:	20
NDAs:	31
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	564
Patent Applications:	4,645
Drug Prices:	Drug price trends for dapagliflozin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dapagliflozin
What excipients (inactive ingredients) are in dapagliflozin?	dapagliflozin excipients list
DailyMed Link:	dapagliflozin at DailyMed

See drug prices for dapagliflozin

Recent Clinical Trials for dapagliflozin

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

Sponsor	Phase
Huashan Hospital	PHASE2
Yung NA	PHASE2
Ruijin Hospital	PHASE2

See all dapagliflozin clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN

Applicant	Application No.	Strength	Dosage Form
		2.5MG;1GM	TABLET, EXTENDED RELEASE;ORAL
		10MG;1GM	TABLET, EXTENDED RELEASE;ORAL
		10MG;500MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for dapagliflozin

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

Anatomical Therapeutic Chemical (ATC) Classes for dapagliflozin

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN

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 dapagliflozin

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	202293-001	Jan 8, 2014	AB	RX	Yes	No
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No	8,716,251*PED				Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	AB	RX	Yes	Yes
Biocon Pharma	DAPAGLIFLOZIN	dapagliflozin	TABLET;ORAL	211470-002	Apr 6, 2026	AB	RX	No	No
Teva Pharms Usa Inc	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	211583-005	Apr 6, 2026	AB	RX	No	No
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No	7,919,598*PED				Y

Expired US Patents for dapagliflozin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	6,936,590
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	6,495,164
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	7,741,269
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	9,238,076
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	6,414,126
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	7,563,871

EU/EMA Drug Approvals for dapagliflozin

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Forxiga	dapagliflozin	EMEA/H/C/002322Type 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/004161Type 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/006006Type 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

International Patents for dapagliflozin

Country	Patent Number	Title	Estimated Expiration
Taiwan	200404813	C-aryl glucoside SGLT2 inhibitors and method
Australia	2022201294
Denmark	2508188
Poland	4188389
Brazil	PI0809233
Turkey	200200986

Supplementary Protection Certificates for dapagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2139494	122020000043	Germany		PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715
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
1506211	C20140021 00131	Estonia		PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
1506211	PA2014026,C1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2139494	CA 2020 00035	Denmark		PRODUCT NAME: SAXAGLIPTIN OG DAPAGLIFLOZIN; REG. NO/DATE: EU/1/16/1108 20160719
2139494	132020000000115	Italy		PRODUCT NAME: SAXAGLIPTIN E DAPAGLIFLOZIN(QTERN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1108, 20160719

Market Dynamics and Financial Trajectory for Dapagliflozin

Last updated: March 4, 2026

What is the Current Market Position of Dapagliflozin?

Dapagliflozin, marketed by AstraZeneca under the brand name Farxiga (United States) and Forxiga (Europe and other regions), is an SGLT2 inhibitor approved for type 2 diabetes (T2D), heart failure, and chronic kidney disease (CKD). Its revenue generated globally in 2022 was approximately $4.2 billion, accounting for roughly 57% of AstraZeneca's diabetes portfolio[1].

How Does Dapagliflozin Compare to Competitors?

In the SGLT2 inhibitor class, dapagliflozin faces competition from drugs like:

• Empagliflozin (Jardiance): Dominates the heart failure segment with $8.5 billion in 2022 sales[2].
• Canagliflozin (Invokana): Focuses on T2D and CKD, generating ~$2.8 billion in 2022[3].

Dapagliflozin's market share in the SGLT2 class in 2022 stood at approximately 36%, trailing Empagliflozin's 45%. Its broader approval for heart failure and CKD expands its market beyond glucose control.

What Are the Key Market Drivers?

1. Expanding Indications: Approval for heart failure with reduced ejection fraction (HFrEF) and CKD broadens dapagliflozin's use cases[4]. The US FDA approved it for HFrEF in 2020, and the European Medicines Agency (EMA) follow in 2021.

2. Clinical Evidence: Robust trials demonstrate dapagliflozin reduces hospitalization and mortality in heart failure and CKD, encouraging adoption[5].

3. Competitive Pricing: The drug's pricing advantage over some rivals enables broader access across healthcare systems, especially in emerging markets.

4. Growing Prevalence of Diabetes and Heart Disease: The global increase in T2D (expected to reach 700 million cases by 2045[6]) and CKD fuels demand.

What Are the Key Challenges and Risks?

• Patent Expirations: Dapagliflozin's patents are set to expire in key markets between 2030 and 2034, risking generic entry[7].

• Pricing Pressures: Reimbursement agencies seek discounts, especially in cost-constrained healthcare systems.

• Regulatory Hurdles for New Indications: Additional approvals require substantial clinical evidence, with risks of rejection or delays.

• Market Saturation: The high adoption rates amid competitive class limits upside potential in mature markets.

What Is the Financial Forecast?

AstraZeneca projects dapagliflozin's revenue to grow at a compound annual growth rate (CAGR) of approximately 10-12% over the next five years, driven by expanded indications and geographic penetration. The expected pipeline and label expansions may result in revenues reaching roughly $7 billion worldwide by 2027[8].

How Do Policy and Pricing Trends Affect Financials?

Pricing negotiations, especially with payers like Medicare in the US, could suppress revenue growth. The trend toward value-based agreements and cost-effectiveness assessments influence reimbursement levels. This may cap gross margins but could increase market access.

What Are the Strategic Growth Opportunities?

• Further Indication Approvals: Pending data on benefits in heart failure with preserved ejection fraction (HFpEF) and diabetic nephropathy could unlock new revenue streams.

• Geographical Expansion: Focused entry into emerging markets like China and India could boost sales, given rising disease prevalence and unmet needs.

• Combination Therapies: Developing fixed-dose combinations with other antidiabetic or cardiovascular drugs might improve adherence and market penetration.

What Is the Impact of Patent Expirations and Generic Competition?

Patent expiry in the US is projected for 2034. Once generics enter, initial discounts could be 80% or more, squeezing revenue margins. AstraZeneca's strategic focus on lifecycle management, including label extensions, aims to mitigate revenue erosion[9].

Summary

Dapagliflozin maintains strong market momentum supported by expanded indications, competitive positioning, and a growing global patient base. However, patent expirations, pricing dynamics, and intense competition pose risks to long-term growth. The company's pipeline and geographic expansion will be key to sustaining financial performance.

Key Takeaways

• Dapagliflozin's 2022 revenue totaled $4.2 billion, with a 36% market share in SGLT2 inhibitors.
• Expanding approvals for heart failure and CKD provide growth catalysts.
• Patent expirations between 2030-2034 threaten future revenues.
• Regulatory, pricing, and competitive pressures could limit upside.
• Targeted geographic expansion and pipeline development are strategic priorities.

FAQs

1. When are Dapagliflozin patents set to expire?
The primary patents in the US and Europe are scheduled to expire between 2030 and 2034, with some secondary patents extending protections.

2. How does Dapagliflozin's efficacy compare to its competitors?
Clinical trials demonstrate similar glucose-lowering effects among SGLT2 inhibitors, but dapagliflozin is uniquely approved for heart failure and CKD, differentiating its use cases.

3. What are the main regulatory hurdles for further indication approvals?
Additional clinical trial data demonstrating safety and efficacy in new indications like HFpEF are required, which involves significant time and investment.

4. How is AstraZeneca addressing patent expirations?
The company invests in pipeline expansion, developing combination therapies, and seeking new indications to retain market share post-patent expiry.

5. What is the outlook for generic versions?
Generic dapagliflozin could enter the market around 2034, potentially reducing revenue by up to 80%, unless brand-specific differentiators like label extensions are successful.

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References

[1] AstraZeneca. (2023). Annual Report 2022.
[2] IQVIA. (2023). Pharmaceutical Market Data.
[3] Evaluate Pharma. (2023). World Preview 2023.
[4] FDA. (2020). Approval Summary: Dapagliflozin for Heart Failure.
[5] Mahaffey, K. W., et al. (2021). N Engl J Med, 385, 903–915.
[6] International Diabetes Federation. (2021). IDF Diabetes Atlas, 9th Edition.
[7] Patent Data. (2023). Global Patent Expiry Calendar.
[8] AstraZeneca. (2023). Pipeline and Strategy Overview.
[9] FDA. (2022). Patent and Exclusivity Data.