LINAGLIPTIN Drug Patent Profile

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

Linagliptin is a drug marketed by Sunshine and Zydus Pharms and is included in four NDAs.

The generic ingredient in LINAGLIPTIN 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

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

Summary for LINAGLIPTIN

US Patents:	0
Applicants:	2
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	139
Patent Applications:	1,898
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LINAGLIPTIN
DailyMed Link:	LINAGLIPTIN at DailyMed

Recent Clinical Trials for LINAGLIPTIN

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

Sponsor	Phase
EMS	Phase 3
Huashan Hospital	Phase 3
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	N/A

See all LINAGLIPTIN clinical trials

Medical Subject Heading (MeSH) Categories for LINAGLIPTIN

Dipeptidyl-Peptidase IV Inhibitors

Hypoglycemic Agents

Incretins

Anatomical Therapeutic Chemical (ATC) Classes for LINAGLIPTIN

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for LINAGLIPTIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRADJENTA	Tablets	linagliptin	5 mg	201280	11	2015-05-04

US Patents and Regulatory Information for LINAGLIPTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sunshine	LINAGLIPTIN	linagliptin	TABLET;ORAL	208335-001	Aug 31, 2021	AB	RX	No	No
Zydus Pharms	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	linagliptin; metformin hydrochloride	TABLET;ORAL	208449-001	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
Zydus Pharms	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	linagliptin; metformin hydrochloride	TABLET;ORAL	208449-002	Mar 30, 2023		DISCN	No	No
Zydus Pharms	LINAGLIPTIN	linagliptin	TABLET;ORAL	208448-001	Mar 30, 2023		DISCN	No	No

EU/EMA Drug Approvals for LINAGLIPTIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Trajenta	linagliptin	EMEA/H/C/002110 Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:as monotherapyin patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.as combination therapyin combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.	Authorised	no	no	no	2011-08-23