Linagliptin - Generic Drug Details

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

Linagliptin is the generic ingredient in five branded drugs marketed by Invagen Pharms, Sunshine, Zydus Pharms, and Boehringer Ingelheim, and is included in eight NDAs. There are fifteen 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 fifty-nine 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:	459
US Patents:	15
Tradenames:	5
Applicants:	4
NDAs:	8
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	142
Patent Applications:	3,298
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
Diabetes & Endocrinology Foundation	N/A
Medanta, The Medicity, India	N/A

See all linagliptin clinical trials

Generic filers with tentative approvals for LINAGLIPTIN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	5MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	2.5MG; 850MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	2.5MG; 500MG	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

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

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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
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	⤷ Sign Up	⤷ Sign Up
>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
Norway	20130968		⤷ Sign Up
European Patent Office	2283819	Compositions d'inhibiteurs de la DPP IV (DPP IV inhibitor formulations)	⤷ Sign Up
Poland	216134		⤷ Sign Up
Eurasian Patent Organization	201001167	8-[-3-АМИНОПИПЕРИДИН-1-ИЛ]КСАНТИНЫ, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ В КАЧЕСТВЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ	⤷ Sign Up
Hong Kong	1134077	-氨基-哌啶- -基 -黃嘌呤，其製備方法及作為藥物製劑的用途 (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS 8-[3---1-]-)	⤷ Sign Up
South Korea	20140068267	METHOD FOR PRODUCING CHIRAL 8-(3-AMINO-PIPERIDIN-1-YL)-XANTHINES	⤷ Sign Up
>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
1532149	118 5013-2011	Slovakia	⤷ Sign Up	PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001 - EU/1/11/707/011 20110824
1532149	C 2012 003	Romania	⤷ Sign Up	PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-IL)-7-BUT-2-INIL-3-METIL-1-(4-METILCHINAZOLIN-2-ILMETIL)3,7-DIHIDROPURIN-2,6-DIONA, ENANTIOMERII SI SARURILE LOR IN SPECIAL LINAGLIPTIN - LINAGLIPTIN, ENANTIOMERIISI SARURILE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/707/001 - RO EU/1/11/707/011; DATE OF NATIONAL AUTHORISATION: 20110824; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/707/001 - EU/1/11/707/011; DATE OF FIRST AUTHORISATION IN EEA: 20110824
2187879	20/2017	Austria	⤷ Sign Up	PRODUCT NAME: KOMBINATION VON EMPAGLIFLOZIN UND LINAGLIPTIN ODER PHARMAZEUTISCH VERTRETBARE SALZE; REGISTRATION NO/DATE: EU/1/16/1146 (MITTEILUNG) 20161115
2187879	122017000024	Germany	⤷ Sign Up	PRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111
2187879	CA 2017 00019	Denmark	⤷ Sign Up	PRODUCT NAME: KOMBINATION AF EMPAGLIFLOZIN OG LINAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/16/1146/001-018 20161115
1084705	PA2014044	Lithuania	⤷ Sign Up	PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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