LINAGLIPTIN AND METFORMIN HYDROCHLORIDE Drug Patent Profile

When do Linagliptin And Metformin Hydrochloride patents expire, and when can generic versions of Linagliptin And Metformin Hydrochloride launch?

Linagliptin And Metformin Hydrochloride is a drug marketed by Sunshine and Zydus Pharms and is included in two NDAs.

The generic ingredient in LINAGLIPTIN AND METFORMIN HYDROCHLORIDE is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Linagliptin And Metformin Hydrochloride

A generic version of LINAGLIPTIN AND METFORMIN HYDROCHLORIDE was approved as linagliptin; metformin hydrochloride by SUNSHINE on August 30^th, 2021.

Summary for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

US Patents:	0
Applicants:	2
NDAs:	2
Clinical Trials:	61
DailyMed Link:	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Medanta, The Medicity, India	N/A
Dong Wha Pharmaceutical Co. Ltd.	Phase 1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	N/A

See all LINAGLIPTIN AND METFORMIN HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sunshine	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	linagliptin; metformin hydrochloride	TABLET;ORAL	208336-003	Aug 30, 2021	AB	RX	No	No
Zydus Pharms	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	linagliptin; metformin hydrochloride	TABLET;ORAL	208449-003	Mar 30, 2023		DISCN	No	No
Sunshine	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	linagliptin; metformin hydrochloride	TABLET;ORAL	208336-001	Aug 30, 2021	AB	RX	No	No
Sunshine	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	linagliptin; metformin hydrochloride	TABLET;ORAL	208336-002	Aug 30, 2021	AB	RX	No	No
Zydus Pharms	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	linagliptin; metformin hydrochloride	TABLET;ORAL	208449-002	Mar 30, 2023		DISCN	No	No
Zydus Pharms	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	linagliptin; metformin hydrochloride	TABLET;ORAL	208449-001	Mar 30, 2023		DISCN	No	No

EU/EMA Drug Approvals for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Jentadueto	linagliptin, metformin hydrochloride	EMEA/H/C/002279 Treatment of adult patients with type-2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.	Authorised	no	no	no	2012-07-19