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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Farxiga
A generic version of FARXIGA was approved as dapagliflozin by ZYDUS PHARMS on February 22nd, 2022.
Summary for FARXIGA
| International Patents: | 381 |
| US Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 134 |
| Clinical Trials: | 46 |
| Patent Applications: | 2,047 |
| 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 |
Recent Clinical Trials for FARXIGA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Karolinska University Hospital | Phase 3 |
| Skane University Hospital | Phase 3 |
| Erasmus Medical Center | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for FARXIGA
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 |
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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.
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