Empagliflozin; Metformin Hydrochloride Patent Expiration

Empagliflozin; Metformin Hydrochloride is Used for improving cardiovascular outcomes and managing type 2 diabetes, including in patients with renal impairment, by administering empagliflozin in combination with other medications. It was first introduced by Boehringer Ingelheim Pharmaceuticals Inc in its drug Synjardy on Aug 26, 2015. Another drug containing Empagliflozin; Metformin Hydrochloride is Synjardy Xr. 2 different companies have introduced drugs containing Empagliflozin; Metformin Hydrochloride.


Empagliflozin; Metformin Hydrochloride Patents

Given below is the list of patents protecting Empagliflozin; Metformin Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Synjardy US10258637 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Synjardy US10258637

(Pediatric)

Pharmaceutical composition, methods for treating and uses thereof Oct 03, 2034 Boehringer Ingelheim
Synjardy US10610489 Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof Sep 30, 2030 Boehringer Ingelheim
Synjardy US10610489

(Pediatric)

Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof Mar 30, 2031 Boehringer Ingelheim
Synjardy US11090323 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Synjardy US11090323

(Pediatric)

Pharmaceutical composition, methods for treating and uses thereof Oct 03, 2034 Boehringer Ingelheim
Synjardy US11813275 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Synjardy US11833166 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Synjardy US7579449 Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture Aug 01, 2028 Boehringer Ingelheim
Synjardy US7579449

(Pediatric)

Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture Feb 01, 2029 Boehringer Ingelheim
Synjardy US7713938 Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments Apr 15, 2027 Boehringer Ingelheim
Synjardy US7713938

(Pediatric)

Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments Oct 15, 2027 Boehringer Ingelheim
Synjardy US9949997 Pharmaceutical composition, methods for treating and uses thereof May 17, 2034 Boehringer Ingelheim
Synjardy US9949997

(Pediatric)

Pharmaceutical composition, methods for treating and uses thereof Nov 17, 2034 Boehringer Ingelheim
Synjardy Xr US10258637 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Synjardy Xr US10258637

(Pediatric)

Pharmaceutical composition, methods for treating and uses thereof Oct 03, 2034 Boehringer Ingelheim
Synjardy Xr US10596120 Pharmaceutical compositions Mar 07, 2032 Boehringer Ingelheim
Synjardy Xr US10596120

(Pediatric)

Pharmaceutical compositions Sep 07, 2032 Boehringer Ingelheim
Synjardy Xr US11090323 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Synjardy Xr US11090323

(Pediatric)

Pharmaceutical composition, methods for treating and uses thereof Oct 03, 2034 Boehringer Ingelheim
Synjardy Xr US11813275 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Synjardy Xr US11833166 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Synjardy Xr US6488962 Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms Jun 20, 2020

(Expired)

Boehringer Ingelheim
Synjardy Xr US7579449 Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture Aug 01, 2028 Boehringer Ingelheim
Synjardy Xr US7579449

(Pediatric)

Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture Feb 01, 2029 Boehringer Ingelheim
Synjardy Xr US7713938 Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments Apr 15, 2027 Boehringer Ingelheim
Synjardy Xr US7713938

(Pediatric)

Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments Oct 15, 2027 Boehringer Ingelheim
Synjardy Xr US9949997 Pharmaceutical composition, methods for treating and uses thereof May 17, 2034 Boehringer Ingelheim
Synjardy Xr US9949997

(Pediatric)

Pharmaceutical composition, methods for treating and uses thereof Nov 17, 2034 Boehringer Ingelheim
Synjardy Xr US9949998 Pharmaceutical composition, methods for treating and uses thereof Jun 11, 2034 Boehringer Ingelheim
Synjardy Xr US9949998

(Pediatric)

Pharmaceutical composition, methods for treating and uses thereof Dec 11, 2034 Boehringer Ingelheim


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 Empagliflozin; Metformin Hydrochloride's patents.

Given below is the list recent legal activities going on the following patents of Empagliflozin; Metformin Hydrochloride.

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 27 Sep, 2023 US10610489
Payment of Maintenance Fee, 4th Year, Large Entity 13 Sep, 2023 US10596120
Recordation of Patent Grant Mailed 07 Apr, 2020 US10610489
Patent Issue Date Used in PTA Calculation 07 Apr, 2020 US10610489
Recordation of Patent Grant Mailed 24 Mar, 2020 US10596120
Patent Issue Date Used in PTA Calculation 24 Mar, 2020 US10596120
Email Notification 19 Mar, 2020 US10610489
Issue Notification Mailed 18 Mar, 2020 US10610489
Correspondence Address Change 12 Mar, 2020 US10596120
Dispatch to FDC 05 Mar, 2020 US10610489



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Empagliflozin; Metformin Hydrochloride Generics

Several generic applications have been filed for Empagliflozin; Metformin Hydrochloride.

Given below is the list of companies who have filed for Empagliflozin; Metformin Hydrochloride generic.


1. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Empagliflozin; Metformin Hydrochloride. All of these versions come by the name EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG; 500MG tablet Discontinued ORAL N/A Jul 7, 2022
5MG; 1GM tablet Discontinued ORAL N/A Jul 7, 2022
12.5MG; 500MG tablet Discontinued ORAL N/A Jul 7, 2022
12.5MG; 1GM tablet Discontinued ORAL N/A Jul 7, 2022