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. 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US6414126 | C-aryl glucoside SGLT2 inhibitors and method |
Oct, 2020
(3 years ago) |
Expired
|
| US6515117 | C-aryl glucoside SGLT2 inhibitors and method |
Oct, 2025
(1 year, 2 months from now) | Active |
| US7919598 | Crystal structures of SGLT2 inhibitors and processes for preparing same |
Dec, 2029
(5 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6936590 | C-aryl glucoside SGLT2 inhibitors and method |
Oct, 2020
(3 years ago) |
Expired
|
| US9198925 | Pharmaceutical formulations containing an SGLT2 inhibitor |
Oct, 2020
(3 years ago) |
Expired
|
| US9238076 | Polymer-based sustained release device |
Apr, 2024
(3 months ago) |
Expired
|
| US8431685 | Polymer-based sustained release device |
Apr, 2025
(8 months from now) | Active |
| US8461105 | Polymer-based sustained release device |
Apr, 2025
(8 months from now) | Active |
| US7456254 | Polymer-based sustained release device |
Jun, 2025
(11 months from now) | Active |
|
US8431685 (Pediatric) | Polymer-based sustained release device |
Oct, 2025
(1 year, 2 months from now) | Active |
|
US8461105 (Pediatric) | Polymer-based sustained release device |
Oct, 2025
(1 year, 2 months from now) | Active |
|
US7456254 (Pediatric) | Polymer-based sustained release device |
Dec, 2025
(1 year, 5 months from now) | Active |
|
US6515117 (Pediatric) | C-aryl glucoside SGLT2 inhibitors and method |
Apr, 2026
(1 year, 8 months from now) | Active |
| US8906851 | Method for treating diabetes |
Aug, 2026
(2 years from now) | Active |
| US8329648 | Methods for treating diabetes and reducing body weight |
Aug, 2026
(2 years from now) | Active |
|
US8906851 (Pediatric) | Method for treating diabetes |
Feb, 2027
(2 years from now) | Active |
|
US8329648 (Pediatric) | Methods for treating diabetes and reducing body weight |
Feb, 2027
(2 years from now) | Active |
| US8501698 | Crystal structures of SGLT2 inhibitors and processes for preparing same |
Jun, 2027
(2 years from now) | Active |
|
US8501698 (Pediatric) | Crystal structures of SGLT2 inhibitors and processes for preparing same |
Dec, 2027
(3 years from now) | Active |
| US8221786 | 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 |
| US8361972 | Pharmaceutical formulations containing an SGLT2 inhibitor |
Mar, 2028
(3 years from now) | Active |
| US7851502 | Pharmaceutical formulations containing an SGLT2 inhibitor |
Aug, 2028
(4 years from now) | Active |
|
US8716251 (Pediatric) | Pharmaceutical formulations containing an SGLT2 inhibitor |
Sep, 2028
(4 years from now) | Active |
|
US8221786 (Pediatric) | Pharmaceutical formulations containing an SGLT2 inhibitor |
Sep, 2028
(4 years from now) | Active |
|
US8361972 (Pediatric) | Pharmaceutical formulations containing an SGLT2 inhibitor |
Sep, 2028
(4 years from now) | Active |
|
US7851502 (Pediatric) | Pharmaceutical formulations containing an SGLT2 inhibitor |
Feb, 2029
(4 years from now) | Active |
| US8721615 | Ampoule comprising an ampoule holder |
Jan, 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 |
|
US7919598 (Pediatric) | Crystal structures of SGLT2 inhibitors and processes for preparing same |
Jun, 2030
(5 years from now) | Active |
|
US8721615 (Pediatric) | Ampoule comprising an ampoule holder |
Jul, 2030
(5 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
(6 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 |
|
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 |
| US11903955 | Methods of treating heart failure with reduced ejection fraction |
Mar, 2040
(15 years from now) | Active |
| US10973836 | Methods of treating heart failure with reduced ejection fraction |
Mar, 2040
(15 years from now) | Active |
|
US11903955 (Pediatric) | Methods of treating heart failure with reduced ejection fraction |
Sep, 2040
(16 years from now) | Active |
|
US10973836 (Pediatric) | Methods of treating heart failure with reduced ejection fraction |
Sep, 2040
(16 years from now) | Active |
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.
Latest Legal Activities on Farxiga's Patents
Given below is the list of recent legal activities going on the following patents of Farxiga.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 |
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 |
|---|---|---|---|
 | |||
| 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
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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 Generics:
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 |
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.
Market Authorisation Date:
Farxiga was approved by FDA for market use on 08 January, 2014.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. 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 |
|---|---|---|---|
| 5MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |