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Synjardy Xr patents expiration

SYNJARDY XR'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).
US6488962 BOEHRINGER INGELHEIM Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
Jun, 2020

(3 years ago)

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)

US10596120 BOEHRINGER INGELHEIM Pharmaceutical compositions
Mar, 2032

(7 years from now)

US10596120

(Pediatric)

BOEHRINGER INGELHEIM Pharmaceutical compositions
Sep, 2032

(8 years from now)

US10258637 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)

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

(9 years from now)

US11090323 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)

US9949998 BOEHRINGER INGELHEIM Pharmaceutical composition, methods for treating and uses thereof
Jun, 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)

US9949998

(Pediatric)

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

(10 years from now)

Synjardy Xr is owned by Boehringer Ingelheim.

Synjardy Xr contains Empagliflozin; Metformin Hydrochloride.

Synjardy Xr has a total of 17 drug patents out of which 1 drug patent has expired.

Expired drug patents of Synjardy Xr are:

  • US6488962

Synjardy Xr was authorised for market use on 09 December, 2016.

Synjardy Xr is available in tablet, extended release;oral dosage forms.

Synjardy Xr can be used as 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, 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, treatment of a treatment-naïve patient with inadequately controlled type 2 diabetes using a composition comprising an extended release core comprising metformin and an outer coating comprising 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>=45 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 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.

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

The generics of Synjardy Xr are possible to be released after 11 December, 2034.

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 01, 2019
M(M-296) Jun 20, 2026
Pediatric Exclusivity(PED) Dec 20, 2026
New Indication(I-739) Dec 02, 2019

Drugs and Companies using EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ingredient

NCE-1 date: 20 December, 2025

Market Authorisation Date: 09 December, 2016

Treatment: Treatment of a treatment-naïve patient with inadequately controlled type 2 diabetes using a composition comprising an extended release core comprising metformin and an outer coating comprising empagli...

Dosage: TABLET, EXTENDED RELEASE;ORAL

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SYNJARDY XR family patents

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