Farxiga Patent Expiration

Farxiga is a drug owned by Astrazeneca Ab. It is protected by 38 US drug patents filed from 2014 to 2024. Out of these, 34 drug patents are active and 4 have expired. Farxiga's patents will be open to challenges from 12 December, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 09, 2040. Details of Farxiga's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US7919598 Crystal structures of SGLT2 inhibitors and processes for preparing same
Dec, 2029

(5 years from now)

Active
US6515117 C-aryl glucoside SGLT2 inhibitors and method
Oct, 2025

(9 months from now)

Active
US6414126 C-aryl glucoside SGLT2 inhibitors and method
Oct, 2020

(4 years ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10973836

(Pediatric)

Methods of treating heart failure with reduced ejection fraction
Sep, 2040

(15 years from now)

Active
US11903955

(Pediatric)

Methods of treating heart failure with reduced ejection fraction
Sep, 2040

(15 years from now)

Active
US10973836 Methods of treating heart failure with reduced ejection fraction
Mar, 2040

(15 years from now)

Active
US11903955 Methods of treating heart failure with reduced ejection fraction
Mar, 2040

(15 years from now)

Active
US11826376

(Pediatric)

Methods of treating heart failure with preserved ejection fraction employing dapagliflozin and compositions comprising the same
Jan, 2040

(15 years from now)

Active
US11826376 Methods of treating heart failure with preserved ejection fraction employing dapagliflozin and compositions comprising the same
Jul, 2039

(14 years from now)

Active
US8685934

(Pediatric)

Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Nov, 2030

(5 years from now)

Active
US8721615

(Pediatric)

Ampoule comprising an ampoule holder
Jul, 2030

(5 years from now)

Active
US7919598

(Pediatric)

Crystal structures of SGLT2 inhibitors and processes for preparing same
Jun, 2030

(5 years from now)

Active
US8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
May, 2030

(5 years from now)

Active
US8721615 Ampoule comprising an ampoule holder
Jan, 2030

(5 years from now)

Active
US7851502

(Pediatric)

Pharmaceutical formulations containing an SGLT2 inhibitor
Feb, 2029

(4 years from now)

Active
US8361972

(Pediatric)

Pharmaceutical formulations containing an SGLT2 inhibitor
Sep, 2028

(3 years from now)

Active
US8716251

(Pediatric)

Pharmaceutical formulations containing an SGLT2 inhibitor
Sep, 2028

(3 years from now)

Active
US8221786

(Pediatric)

Pharmaceutical formulations containing an SGLT2 inhibitor
Sep, 2028

(3 years from now)

Active
US7851502 Pharmaceutical formulations containing an SGLT2 inhibitor
Aug, 2028

(3 years from now)

Active
US8221786 Pharmaceutical formulations containing an SGLT2 inhibitor
Mar, 2028

(3 years from now)

Active
US8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Mar, 2028

(3 years from now)

Active
US8716251 Pharmaceutical formulations containing an SGLT2 inhibitor
Mar, 2028

(3 years from now)

Active
US8501698

(Pediatric)

Crystal structures of SGLT2 inhibitors and processes for preparing same
Dec, 2027

(3 years from now)

Active
US8501698 Crystal structures of SGLT2 inhibitors and processes for preparing same
Jun, 2027

(2 years from now)

Active
US8329648

(Pediatric)

Methods for treating diabetes and reducing body weight
Feb, 2027

(2 years from now)

Active
US8906851

(Pediatric)

Method for treating diabetes
Feb, 2027

(2 years from now)

Active
US8329648 Methods for treating diabetes and reducing body weight
Aug, 2026

(1 year, 8 months from now)

Active
US8906851 Method for treating diabetes
Aug, 2026

(1 year, 8 months from now)

Active
US6515117

(Pediatric)

C-aryl glucoside SGLT2 inhibitors and method
Apr, 2026

(1 year, 3 months from now)

Active
US7456254

(Pediatric)

Polymer-based sustained release device
Dec, 2025

(1 year, 15 days from now)

Active
US8431685

(Pediatric)

Polymer-based sustained release device
Oct, 2025

(9 months from now)

Active
US8461105

(Pediatric)

Polymer-based sustained release device
Oct, 2025

(9 months from now)

Active
US7456254 Polymer-based sustained release device
Jun, 2025

(6 months from now)

Active
US8461105 Polymer-based sustained release device
Apr, 2025

(3 months from now)

Active
US8431685 Polymer-based sustained release device
Apr, 2025

(3 months from now)

Active
US9238076 Polymer-based sustained release device
Apr, 2024

(7 months ago)

Expired
US9198925 Pharmaceutical formulations containing an SGLT2 inhibitor
Oct, 2020

(4 years ago)

Expired
US6936590 C-aryl glucoside SGLT2 inhibitors and method
Oct, 2020

(4 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Farxiga's patents.

Given below is the list of recent legal activities going on the following patents of Farxiga.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 17 Jul, 2024 US8361972
Payment of Maintenance Fee, 12th Year, Large Entity 29 May, 2024 US8329648
Patent eCofC Notification 09 Apr, 2024 US11903955
Recordation of Patent eCertificate of Correction 09 Apr, 2024 US11903955
Mail Patent eCofC Notification 09 Apr, 2024 US11903955
Email Notification 09 Apr, 2024 US11903955
Mail Certificate of Correction Memo 13 Mar, 2024 US11903955
Certificate of Correction Memo 08 Mar, 2024 US11903955
Email Notification 20 Feb, 2024 US11903955
Mail Patent eGrant Notification 20 Feb, 2024 US11903955


FDA has granted several exclusivities to Farxiga. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Farxiga, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Farxiga.

Exclusivity Information

Farxiga holds 10 exclusivities out of which 7 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Farxiga's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
M(M-157) Mar 11, 2018
New Chemical Entity Exclusivity(NCE) Jan 08, 2019
M(M-212) Oct 20, 2020
M(M-238) Feb 22, 2022
New Indication(I-841) Oct 18, 2022
New Indication(I-834) May 05, 2023
New Indication(I-857) Apr 30, 2024
M(M-298) May 08, 2026
New Patient Population(NPP) Jun 12, 2027
Pediatric Exclusivity(PED) Dec 12, 2027

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Several oppositions have been filed on Farxiga's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Farxiga's generic, the next section provides detailed information on ongoing and past EP oppositions related to Farxiga patents.

Farxiga's Oppositions Filed in EPO

Farxiga has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 30, 2015, by Lek Pharmaceuticals D.D.. This opposition was filed on patent number EP07784499A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP08732695A Dec, 2020 Generics [UK] Limited Granted and Under Opposition
EP08732695A Dec, 2020 Kraus & Weisert Patentanwälte PartGmbB Granted and Under Opposition
EP08732695A Dec, 2020 Gedeon Richter Plc. Granted and Under Opposition
EP08732695A Dec, 2020 Stada-Arzneimittel Aktiengesellschaft Granted and Under Opposition
EP08732695A Dec, 2020 Galenicum Health S.L.U. Granted and Under Opposition
EP08732695A Dec, 2020 Zentiva, k.s. Granted and Under Opposition
EP17203302A Aug, 2020 Generics (U.K.) Limited Granted and Under Opposition
EP10016112A Feb, 2020 Generics (UK) Ltd Granted and Under Opposition
EP10016112A Jan, 2020 Instone, Terry/Appleyard Lees IP LLP/Read, Howard Granted and Under Opposition
EP15181545A Sep, 2018 Generics (U.K.) Limited Granted and Under Opposition
EP11180259A Nov, 2015 Teva Pharmaceutical Industries Ltd. Opposition rejected
EP11180259A Nov, 2015 PHARMATHEN S.A. Opposition rejected
EP06801867A Sep, 2015 COOLEY LLP Revoked
EP06801867A Sep, 2015 Generics [UK] Ltd (trading as Mylan) Revoked
EP06801867A Sep, 2015 Teva Pharmaceutical Industries Ltd. Revoked
EP06801867A Sep, 2015 Glaxo Group Limited Revoked
EP06801867A Sep, 2015 PENTAFARMA, Sociedade Técnico-Medicinal, SA Revoked
EP06801867A Aug, 2015 PHARMATHEN S.A. Revoked
EP07784499A Apr, 2015 LEK Pharmaceuticals d.d. Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Farxiga is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Farxiga's family patents as well as insights into ongoing legal events on those patents.

Farxiga's Family Patents

Farxiga has patent protection in a total of 51 countries. It's US patent count contributes only to 17.8% of its total global patent coverage. 8 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Farxiga.

Family Patents

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Generic Launch

Generic Release Date:

Farxiga's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 09, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Farxiga Generic API suppliers:

Dapagliflozin is the generic name for the brand Farxiga. 1 company has already filed for the generic of Farxiga. Check out the entire list of companies who have already received approval for Farxiga's generic

How can I launch a generic of Farxiga before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Farxiga's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Farxiga's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Farxiga -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
5 mg and 10 mg 08 Jan, 2018 20 22 Feb, 2022 26 May, 2030 Deferred

Alternative Brands for Farxiga

Farxiga which is used for treating heart failure and type 2 diabetes., has several other brand drugs in the same treatment category and using the same active ingredient (Dapagliflozin). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Astrazeneca Ab
Qtern

(uses Dapagliflozin)

Used for the treatment of type 2 diabetes mellitus in patients who have inadequate control with dapagliflozin.
Bydureon used for improving glycemic control in patients with type 2 diabetes mellitus.
Xigduo Xr

(uses Dapagliflozin)

used for managing type 2 diabetes mellitus when glycemic control is not achievable with other medications.
Qternmet Xr

(uses Dapagliflozin)

Used for managing blood sugar levels in individuals with type 2 diabetes mellitus.
Bydureon Pen used for improving glycemic control in patients with Type 2 diabetes, reducing food intake, delaying gastric motility, reducing body weight, and stimulating insulin release.
Boehringer Ingelheim
Tradjenta Used for treating type 2 diabetes, especially in patients with renal impairment and insufficient glycemic control.
Cosette
Welchol Used for lowering serum glucose levels in adults with type 2 diabetes mellitus and lowering cholesterol levels.
Janssen Pharms
Invokana used for the treatment of type 2 diabetes mellitus and reduction of cardiovascular and kidney-related risks.
Invokamet Used for reducing the risk of kidney disease, cardiovascular events, and treating type 2 diabetes mellitus patients.
Invokamet Xr used for treating type 2 diabetes and reducing the risk of kidney disease, cardiovascular events, and heart failure.
Sb Pharmco
Avandamet Used for managing and treating type 2 diabetes mellitus.

Apart from brand drugs containing the same ingredient, some generics have also been filed for Dapagliflozin, Farxiga's active ingredient. Check the complete list of approved generic manufacturers for Farxiga





About Farxiga

Farxiga is a drug owned by Astrazeneca Ab. It is used for treating heart failure and type 2 diabetes. Farxiga uses Dapagliflozin as an active ingredient. Farxiga was launched by Astrazeneca Ab in 2014.

Approval Date:

Farxiga was approved by FDA for market use on 08 January, 2014.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Farxiga is 08 January, 2014, its NCE-1 date is estimated to be 12 December, 2026.

Active Ingredient:

Farxiga uses Dapagliflozin as the active ingredient. Check out other Drugs and Companies using Dapagliflozin ingredient

Treatment:

Farxiga is used for treating heart failure and type 2 diabetes.

Dosage:

Farxiga is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
10MG TABLET Prescription ORAL
5MG TABLET Prescription ORAL


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