FARXIGA Drug Patent Profile

✉ Email this page to a colleague

▶ Start for $1
Remove trial restrictions

When do Farxiga patents expire, and when can generic versions of Farxiga launch?

Farxiga is a drug marketed by Astrazeneca Ab and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and ninety patent family members in forty-eight countries.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dapagliflozin profile page.

DrugPatentWatch^® Generic Entry Outlook for Farxiga

Farxiga was eligible for patent challenges on January 8, 2018.

Annual sales in 2019 were $966mm indicating the motivation for generic entry (peak sales were $1.3bn in 2018).

There have been eight 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 are ten tentative approvals for the generic drug (dapagliflozin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

< Available with Subscription >

Try a Trial

Summary for FARXIGA

International Patents:	390
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	47
Patent Applications:	248
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FARXIGA
Drug Sales Revenues:	Drug sales revenues for FARXIGA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FARXIGA
What excipients (inactive ingredients) are in FARXIGA?	FARXIGA excipients list
DailyMed Link:	FARXIGA at DailyMed

Drug patent expirations by year for FARXIGA

Recent Clinical Trials for FARXIGA

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

Sponsor	Phase
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 4
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 4
Oslo University Hospital	Phase 3

See all FARXIGA clinical trials

Pharmacology for FARXIGA

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

Anatomical Therapeutic Chemical (ATC) Classes for FARXIGA

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 FARXIGA

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 FARXIGA

FARXIGA is protected by twenty US patents and four FDA Regulatory Exclusivities.

Patents protecting FARXIGA

Methods of treating heart failure with reduced ejection fraction
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION AND WITHOUT TYPE II DIABETES

C-aryl glucoside SGLT2 inhibitors and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

C-aryl glucoside SGLT2 inhibitors and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Methods for treating diabetes and reducing body weight
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCING HBA1C IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4

Methods for treating diabetes and reducing body weight
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Methods for treating diabetes and reducing body weight
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCING FASTING PLASMA GLUCOSE IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Ampoule comprising an ampoule holder
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Method for treating diabetes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

FDA Regulatory Exclusivity protecting FARXIGA

INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO REFLECT THAT NO DOSE ADJUSTMENT IS NEEDED FOR PATIENTS WITH AN ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) OF 45 ML/MIN/1.73 M2 OR GREATER AS SUPPORTED BY CLINICAL STUDY REPORT
Exclusivity Expiration: ⤷ Try a Trial

TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE (NYHA CLASS II-IV) WITH REDUCED EJECTION FRACTION
Exclusivity Expiration: ⤷ Try a Trial

TO REDUCE THE RISK OF SUSTAINED EGFR DECLINE, END-STAGE KIDNEY DISEASE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION
Exclusivity Expiration: ⤷ Try a Trial

TO REDUCE THE RISK OF HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS
Exclusivity Expiration: ⤷ Try a Trial

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try a Trial
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	202293-002	Jan 8, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for FARXIGA

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for FARXIGA

Subscribe to access the full database, or Try a Trial
Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Forxiga	dapagliflozin	EMEA/H/C/002322 Type 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/004161 Type 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/006006 Type 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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for FARXIGA

When does loss-of-exclusivity occur for FARXIGA?

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

Argentina

Patent: 1730
Estimated Expiration: ⤷ Try a Trial

Australia

Patent: 07265246
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 0713544
Estimated Expiration: ⤷ Try a Trial

Patent: 2017015106
Estimated Expiration: ⤷ Try a Trial

Patent: 2017021516
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 53344
Estimated Expiration: ⤷ Try a Trial

Patent: 24318
Estimated Expiration: ⤷ Try a Trial

Patent: 85797
Estimated Expiration: ⤷ Try a Trial

Chile

Patent: 07001915
Estimated Expiration: ⤷ Try a Trial

China

Patent: 1479287
Estimated Expiration: ⤷ Try a Trial

Patent: 3145773
Estimated Expiration: ⤷ Try a Trial

Colombia

Patent: 60299
Estimated Expiration: ⤷ Try a Trial

Croatia

Patent: 0141007
Estimated Expiration: ⤷ Try a Trial

Cyprus

Patent: 15738
Estimated Expiration: ⤷ Try a Trial

Denmark

Patent: 69374
Estimated Expiration: ⤷ Try a Trial

Eurasian Patent Organization

Patent: 8229
Estimated Expiration: ⤷ Try a Trial

Patent: 0428
Estimated Expiration: ⤷ Try a Trial

Patent: 8259
Estimated Expiration: ⤷ Try a Trial

Patent: 5999
Estimated Expiration: ⤷ Try a Trial

Patent: 0900066
Estimated Expiration: ⤷ Try a Trial

Patent: 1171333
Estimated Expiration: ⤷ Try a Trial

Patent: 1490902
Estimated Expiration: ⤷ Try a Trial

Patent: 1791254
Estimated Expiration: ⤷ Try a Trial

Patent: 2091391
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 69374
Estimated Expiration: ⤷ Try a Trial

Patent: 57918
Estimated Expiration: ⤷ Try a Trial

Patent: 45466
Estimated Expiration: ⤷ Try a Trial

Patent: 63807
Estimated Expiration: ⤷ Try a Trial

Hong Kong

Patent: 27359
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 5882
Estimated Expiration: ⤷ Try a Trial

Patent: 4180
Estimated Expiration: ⤷ Try a Trial

Patent: 4181
Estimated Expiration: ⤷ Try a Trial

Patent: 4182
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 13889
Estimated Expiration: ⤷ Try a Trial

Patent: 66651
Estimated Expiration: ⤷ Try a Trial

Patent: 37187
Estimated Expiration: ⤷ Try a Trial

Patent: 09545525
Estimated Expiration: ⤷ Try a Trial

Patent: 13209394
Estimated Expiration: ⤷ Try a Trial

Patent: 15071636
Estimated Expiration: ⤷ Try a Trial

Patent: 16172758
Estimated Expiration: ⤷ Try a Trial

Patent: 17222681
Estimated Expiration: ⤷ Try a Trial

Patent: 19059779
Estimated Expiration: ⤷ Try a Trial

Malaysia

Patent: 8566
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 9143
Estimated Expiration: ⤷ Try a Trial

Patent: 7155
Estimated Expiration: ⤷ Try a Trial

Patent: 08015377
Estimated Expiration: ⤷ Try a Trial

New Zealand

Patent: 4346
Estimated Expiration: ⤷ Try a Trial

Patent: 9190
Estimated Expiration: ⤷ Try a Trial

Patent: 9195
Estimated Expiration: ⤷ Try a Trial

Patent: 9202
Estimated Expiration: ⤷ Try a Trial

Norway

Patent: 6828
Estimated Expiration: ⤷ Try a Trial

Patent: 085169
Estimated Expiration: ⤷ Try a Trial

Patent: 221233
Estimated Expiration: ⤷ Try a Trial

Peru

Patent: 080349
Estimated Expiration: ⤷ Try a Trial

Patent: 120776
Estimated Expiration: ⤷ Try a Trial

Philippines

Patent: 012500168
Estimated Expiration: ⤷ Try a Trial

Poland

Patent: 69374
Estimated Expiration: ⤷ Try a Trial

Portugal

Patent: 69374
Estimated Expiration: ⤷ Try a Trial

Serbia

Patent: 638
Estimated Expiration: ⤷ Try a Trial

Singapore

Patent: 2741
Estimated Expiration: ⤷ Try a Trial

Patent: 201402181S
Estimated Expiration: ⤷ Try a Trial

Slovenia

Patent: 69374
Estimated Expiration: ⤷ Try a Trial

South Africa

Patent: 0810475
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 1493102
Estimated Expiration: ⤷ Try a Trial

Patent: 090023643
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 21665
Estimated Expiration: ⤷ Try a Trial

Patent: 59862
Estimated Expiration: ⤷ Try a Trial

Patent: 69130
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 21245
Estimated Expiration: ⤷ Try a Trial

Patent: 66876
Estimated Expiration: ⤷ Try a Trial

Patent: 19528
Estimated Expiration: ⤷ Try a Trial

Patent: 0811127
Estimated Expiration: ⤷ Try a Trial

Patent: 1406743
Estimated Expiration: ⤷ Try a Trial

Patent: 1509927
Estimated Expiration: ⤷ Try a Trial

Patent: 1546054
Estimated Expiration: ⤷ Try a Trial

Ukraine

Patent: 765
Estimated Expiration: ⤷ Try a Trial

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 FARXIGA around the world.

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Poland	2409707		⤷ Try a Trial
Germany	102008025011	Ampulle mit Ampullenhalterung	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2021037400		⤷ Try a Trial
Israel	195882	צורות גבישיות של נגזרות של (1 s)-1, 5-אנהידרו-1- c -(3-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמיניות ושימוש בהן לטיפול בסכרת (Crystalline forms of (1s)-1,5-anhydro-1-c-(3-(phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids and use thereof for the treatment of diabetes)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FARXIGA

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140145	SZ 30/2007	Austria	⤷ Try a Trial	PRODUCT NAME: EXENATIDE
1506211	13C0022	France	⤷ Try a Trial	PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
2139494	PA2020522	Lithuania	⤷ Try a Trial	PRODUCT NAME: SASAGLIPTINAS IR DAPAGLIFLOZINAS; REGISTRATION NO/DATE: EU/1/16/1108 20160715
1734971	248 5006-2012	Slovakia	⤷ Try a Trial	PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110623
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description