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Last Updated: April 26, 2024

Linagliptin - Generic Drug Details

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What are the generic drug sources for linagliptin and what is the scope of freedom to operate?

Linagliptin is the generic ingredient in five branded drugs marketed by Sunshine, Zydus Pharms, and Boehringer Ingelheim, and is included in seven NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Linagliptin has four hundred and sixteen patent family members in forty-five countries.

There are nineteen drug master file entries for linagliptin. Three suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for linagliptin

International Patents:	416
US Patents:	14
Tradenames:	5
Applicants:	3
NDAs:	7
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	139
Patent Applications:	3,853
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for linagliptin
What excipients (inactive ingredients) are in linagliptin?	linagliptin excipients list
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

Generic filers with tentative approvals for LINAGLIPTIN

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	5MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	2.5MG; 1G	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	2.5MG; 850MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for linagliptin

Drug Class	Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Medical Subject Heading (MeSH) Categories for linagliptin

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Incretins

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

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Glossary

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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	208336-002	Aug 30, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for linagliptin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for linagliptin

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for linagliptin

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Country	Patent Number	Title	Estimated Expiration
Peru	20080251	USOS DE INHIBIDORES DE DPP IV	⤷ Try a Trial
Japan	2006503013		⤷ Try a Trial
Chile	2012002528	Combinacion farmaceutica que comprende un inhibidor de dpp iv de formula i definida y metamorfina, o una glitazona o tiazolidindiona, o telmisartan; util en el tratamiento de diabetes (divisonal sol 1262-07).	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for linagliptin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2187879	122017000024	Germany	⤷ Try a Trial	PRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111
2187879	132017000050485	Italy	⤷ Try a Trial	PRODUCT NAME: COMBINAZIONE DI EMPAGLIFLOZIN E LINAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GLYXAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1146, 20161115
1730131	C01730131/03	Switzerland	⤷ Try a Trial	PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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