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Last Updated: May 24, 2022

FARXIGA Drug Patent Profile


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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 eighty-one 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.

Drug patent expirations by year for FARXIGA
Drug Prices for FARXIGA

See drug prices for FARXIGA

Drug Sales Revenue Trends for FARXIGA

See drug sales revenues for FARXIGA

Recent Clinical Trials for FARXIGA

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

SponsorPhase
Karolinska University HospitalPhase 3
Skane University HospitalPhase 3
Erasmus Medical CenterPhase 3

See all FARXIGA clinical trials

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

C-aryl glucoside SGLT2 inhibitors and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating diabetes and reducing body weight
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Methods for treating diabetes and reducing body weight
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ampoule comprising an ampoule holder
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for treating diabetes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE

Polymer-based sustained release device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

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: See Plans and Pricing

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: See Plans and Pricing

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: See Plans and Pricing

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 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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: See Plans and Pricing

Australia

Patent: 07265246
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0713544
Estimated Expiration: See Plans and Pricing

Patent: 2017015106
Estimated Expiration: See Plans and Pricing

Patent: 2017021516
Estimated Expiration: See Plans and Pricing

Canada

Patent: 53344
Estimated Expiration: See Plans and Pricing

Patent: 24318
Estimated Expiration: See Plans and Pricing

Patent: 85797
Estimated Expiration: See Plans and Pricing

Chile

Patent: 07001915
Estimated Expiration: See Plans and Pricing

China

Patent: 1479287
Estimated Expiration: See Plans and Pricing

Patent: 3145773
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 60299
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0141007
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15738
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 69374
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8229
Estimated Expiration: See Plans and Pricing

Patent: 0428
Estimated Expiration: See Plans and Pricing

Patent: 8259
Estimated Expiration: See Plans and Pricing

Patent: 5999
Estimated Expiration: See Plans and Pricing

Patent: 0900066
Estimated Expiration: See Plans and Pricing

Patent: 1171333
Estimated Expiration: See Plans and Pricing

Patent: 1490902
Estimated Expiration: See Plans and Pricing

Patent: 1791254
Estimated Expiration: See Plans and Pricing

Patent: 2091391
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 69374
Estimated Expiration: See Plans and Pricing

Patent: 57918
Estimated Expiration: See Plans and Pricing

Patent: 45466
Estimated Expiration: See Plans and Pricing

Patent: 63807
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 27359
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5882
Estimated Expiration: See Plans and Pricing

Patent: 4180
Estimated Expiration: See Plans and Pricing

Patent: 4181
Estimated Expiration: See Plans and Pricing

Patent: 4182
Estimated Expiration: See Plans and Pricing

Patent: 5688
Estimated Expiration: See Plans and Pricing

Japan

Patent: 13889
Estimated Expiration: See Plans and Pricing

Patent: 66651
Estimated Expiration: See Plans and Pricing

Patent: 37187
Estimated Expiration: See Plans and Pricing

Patent: 09545525
Estimated Expiration: See Plans and Pricing

Patent: 13209394
Estimated Expiration: See Plans and Pricing

Patent: 15071636
Estimated Expiration: See Plans and Pricing

Patent: 16172758
Estimated Expiration: See Plans and Pricing

Patent: 17222681
Estimated Expiration: See Plans and Pricing

Patent: 19059779
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 8566
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 9143
Estimated Expiration: See Plans and Pricing

Patent: 7155
Estimated Expiration: See Plans and Pricing

Patent: 08015377
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4346
Estimated Expiration: See Plans and Pricing

Patent: 9190
Estimated Expiration: See Plans and Pricing

Patent: 9195
Estimated Expiration: See Plans and Pricing

Patent: 9202
Estimated Expiration: See Plans and Pricing

Norway

Patent: 085169
Estimated Expiration: See Plans and Pricing

Peru

Patent: 080349
Estimated Expiration: See Plans and Pricing

Patent: 120776
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 012500168
Estimated Expiration: See Plans and Pricing

Poland

Patent: 69374
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 69374
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 638
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 2741
Estimated Expiration: See Plans and Pricing

Patent: 201402181S
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 69374
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0810475
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1493102
Estimated Expiration: See Plans and Pricing

Patent: 090023643
Estimated Expiration: See Plans and Pricing

Spain

Patent: 21665
Estimated Expiration: See Plans and Pricing

Patent: 59862
Estimated Expiration: See Plans and Pricing

Patent: 69130
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 21245
Estimated Expiration: See Plans and Pricing

Patent: 66876
Estimated Expiration: See Plans and Pricing

Patent: 19528
Estimated Expiration: See Plans and Pricing

Patent: 0811127
Estimated Expiration: See Plans and Pricing

Patent: 1406743
Estimated Expiration: See Plans and Pricing

Patent: 1509927
Estimated Expiration: See Plans and Pricing

Patent: 1546054
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 765
Estimated Expiration: See Plans and Pricing

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.

Country Patent Number Title Estimated Expiration
Poland 210304 See Plans and Pricing
Hong Kong 1166606 POLYMER-BASED SUSTAINED RELEASE DEVICE See Plans and Pricing
China 100425284 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FARXIGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 2014C/041 Belgium See Plans and Pricing PRODUCT NAME: LA COMBINAISON DE DAPAGLIFLOZINE (OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE); AUTHORISATION NUMBER AND DATE: EU/1/13/900 20140121
1506211 179 5017-2014 Slovakia See Plans and Pricing 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
0996459 CA 2007 00034 Denmark See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
Baxter
Dow
Harvard Business School
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.