Pharsight

Synjardy patents expiration

SYNJARDY's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7713938 BOEHRINGER INGELHEIM 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, 2027

(2 years from now)

US7579449 BOEHRINGER INGELHEIM Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Aug, 2028

(4 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7713938

(Pediatric)

BOEHRINGER INGELHEIM 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, 2027

(3 years from now)

US7579449

(Pediatric)

BOEHRINGER INGELHEIM Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Feb, 2029

(4 years from now)

US10610489 BOEHRINGER INGELHEIM Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof
Sep, 2030

(6 years from now)

US10610489

(Pediatric)

BOEHRINGER INGELHEIM Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof
Mar, 2031

(6 years from now)

US11090323 BOEHRINGER INGELHEIM Pharmaceutical composition, methods for treating and uses thereof
Apr, 2034

(9 years from now)

US11833166 BOEHRINGER INGELHEIM Pharmaceutical composition, methods for treating and uses thereof
Apr, 2034

(9 years from now)

US11813275 BOEHRINGER INGELHEIM Pharmaceutical composition, methods for treating and uses thereof
Apr, 2034

(9 years from now)

US10258637 BOEHRINGER INGELHEIM Pharmaceutical composition, methods for treating and uses thereof
Apr, 2034

(9 years from now)

US9949997 BOEHRINGER INGELHEIM Pharmaceutical composition, methods for treating and uses thereof
May, 2034

(10 years from now)

US11090323

(Pediatric)

BOEHRINGER INGELHEIM Pharmaceutical composition, methods for treating and uses thereof
Oct, 2034

(10 years from now)

US10258637

(Pediatric)

BOEHRINGER INGELHEIM Pharmaceutical composition, methods for treating and uses thereof
Oct, 2034

(10 years from now)

US9949997

(Pediatric)

BOEHRINGER INGELHEIM Pharmaceutical composition, methods for treating and uses thereof
Nov, 2034

(10 years from now)

Synjardy is owned by Boehringer Ingelheim.

Synjardy contains Empagliflozin; Metformin Hydrochloride.

Synjardy has a total of 14 drug patents out of which 0 drug patents have expired.

Synjardy was authorised for market use on 26 August, 2015.

Synjardy is available in tablet;oral dosage forms.

Synjardy can be used as method of treating type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 m2<=egfr<60 ml/min/1.73 m2) by once daily administration of 10 mg or 25 mg of empagliflozin, method for reducing the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease by once daily administration of 10 mg or 25 mg of empagliflozin, method for reducing the risk of cardiovascular death and hospitalization for heart failure in patients with heart failure and type 2 diabetes mellitus by administration of empagliflozin, treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr is >=30 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control, method of treating type 2 diabetes mellitus in a patent with renal impairment (egfr<60 ml/min/1.73 m2) by initiation of empagliflozin and metformin hcl if egfr>=45 ml/min/1.73 m2 and discontinuation if egfr<30 ml/min/1.73 m2.

Drug patent challenges can be filed against Synjardy from 20 December, 2025.

The generics of Synjardy are possible to be released after 17 November, 2034.

Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Jun 20, 2026
Pediatric Exclusivity(PED) Dec 20, 2026
New Indication(I-739) Dec 02, 2019
New Product(NP) Aug 26, 2018
New Chemical Entity Exclusivity(NCE) Aug 01, 2019
M(M-174) Mar 18, 2019

Drugs and Companies using EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ingredient

NCE-1 date: 20 December, 2025

Market Authorisation Date: 26 August, 2015

Treatment: Method of treating type 2 diabetes mellitus in a patent with renal impairment (egfr<60 ml/min/1.73 m2) by initiation of empagliflozin and metformin hcl if egfr>=45 ml/min/1.73 m2 and discontinuation i...

Dosage: TABLET;ORAL

How can I launch a generic of SYNJARDY before it's drug patent expiration?
More Information on Dosage

SYNJARDY family patents

Family Patents