Linagliptin - Generic Drug Details

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
Wuxi People's Hospital	N/A

See all linagliptin clinical trials

Generic filers with tentative approvals for LINAGLIPTIN

Applicant	Application No.	Strength	Dosage Form
		5MG	TABLET;ORAL
		2.5MG; 1G	TABLET;ORAL
		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

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

Expired US Patents for linagliptin

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

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

International Patents for linagliptin

Country	Patent Number	Title	Estimated Expiration
Japan	2016199572	１−［（［１，５］ナフチリジン−２−イル）メチル］−３−メチル−７−（２−ブチン−１−イル）−８−（（Ｒ）−３−アミノ−ピペリジン−１−イル）−キサンチン、又はその塩 (1-[([1,5]NAPHTHYRIDIN-2-YL)METHYL]-3-METHYL-7-(2-BUTYN-1-YL)-8-((R)-3-AMINO-PIPERIDIN-1-YL)-XANTHINE, OR SALT THEREOF)
Taiwan	201305166	Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Poland	375342	8-[3-aminopiperydyn-1-ylo]-ksantyny, sposób ich wytwarzania i ich zastosowanie jako środki lecznicze (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS)
China	107266449	手性8‑(3‑氨基‑哌啶‑1‑基)‑黄嘌呤的制备方法 (Method for producing chiral 8-(3-amino-piperidin-1-yl)-xanthines)

Supplementary Protection Certificates for linagliptin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2187879	LUC00017	Luxembourg		PRODUCT NAME: GLYXAMBI- EMPAGLIFLOZINE/LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1146 20161115
1532149	SPC/GB12/006	United Kingdom		PRODUCT NAME: LINAGLIPTIN, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/11/707/001 20110830; UK EU/1/11/707/002 20110830; UK EU/1/11/707/003 20110830; UK EU/1/11/707/004 20110830; UK EU/1/11/707/005 20110830; UK EU/1/11/707/006 20110830; UK EU/1/11/707/007 20110830; UK EU/1/11/707/008 20110830; UK EU/1/11/707/009 20110830; UK EU/1/11/707/010 20110830; UK EU/1/11/707/011 20110830
1532149	CA 2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
1532149	PA2011013,C1532149	Lithuania		PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001, 2011-08-24 EU/1/11/707/002, 2011-08-24 EU/1/11/707/003, 2011-08-24 EU/1/11/707/004, 2011-08-24 EU/1/11/707/005, 2011-08-24 EU/1/11/707/006, 2011-08-24 EU/1/11/707/007, 2011-08-24 EU/1/11/707/008, 2011-08-24 EU/1/11/707/00 2011082