farxiga Drug Patent Profile
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When do Farxiga patents expire, and what generic alternatives are available?
Farxiga is a drug marketed by Astrazeneca Ab and is included in one NDA. There are seventeen patents protecting this drug and one Paragraph IV challenge.
This drug has four hundred and thirty-five patent family members in fifty-one countries.
The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this compound. Five 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.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 16, 2029. This may change due to patent challenges or generic licensing.
Annual sales in 2021 were $2.7bn, indicating a strong incentive for generic entry.
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 twelve tentative approvals for the generic drug (dapagliflozin), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for farxiga
International Patents: | 435 |
US Patents: | 17 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 41 |
Clinical Trials: | 47 |
Patent Applications: | 188 |
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for farxiga
Generic Entry Date for farxiga*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 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 |
Sahlgrenska University Hospital, Sweden | Phase 3 |
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
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-one US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of farxiga is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ 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.
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE AND URGENT HEART FAILURE VISITS IN ADULTS WITH HEART FAILURE WITH PRESERVED 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
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
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
LABELING REVISIONS RELATED TO STUDY D1699CC00001
Exclusivity Expiration: ⤷ Try a Trial
Expired US Patents for farxiga
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 | 202293-001 | 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 |
Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | 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 | 202293-002 | 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
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
Patent: 3930
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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 2012010 | ⤷ Try a Trial | |
Finland | 3524261 | ⤷ Try a Trial | |
Luxembourg | 91342 | ⤷ Try a Trial | |
China | 1384755 | ⤷ Try a Trial | |
European Patent Office | 1754469 | Suspensions injectables ayant des charactéristiques d'injectabilité ameliorées (Injectable suspensions having improved injectability properties) | ⤷ Try a Trial |
Slovenia | 1283699 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for farxiga
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1734971 | 91989 | Luxembourg | ⤷ Try a Trial | 91989, EXPIRES: 20260617 |
1506211 | 13C0022 | France | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112 |
1506211 | 122013000033 | Germany | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112 |
2498758 | 132020000000034 | Italy | ⤷ Try a Trial | PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113 |
0996459 | C00996459/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US |
1734971 | 300526 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |