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Linagliptin - Generic Drug Details

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

Linagliptin is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and is included in three NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for linagliptin. Two suppliers are listed for this compound.

Summary for linagliptin

US Patents:	18
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	19
Suppliers / Packagers:	2
Bulk Api Vendors:	67
Clinical Trials:	112
Patent Applications:	478
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for linagliptin
DailyMed Link:	linagliptin at DailyMed

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

Synonyms for linagliptin

(R)-8-(3-Amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione

(R)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione

(R)-8-(3-aminopiperidin-1-yl)-7-(but-2-ynyl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1H-purine-2,6(3H,7H)-dione

(R)-8-(3-aminopiperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methylquinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione

1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-aminopiperidin-1-yl)xanthine

1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)aminopiperidin-1-yl)xanthine

1-[(4-methyl-quinazolin-2yl) methyl]-3-methyl-7-(2-butyn-1-yl)-8-[3-(R) amino-piperidin-1-yl]-xanthine

1-[(4-Methylquinazolin-2-yl)-methyl]-3-methyl-7-(2-butin-1-yl)-8-(3-(R)-aminopiperidin-1-yl)-xanthine

1-[(4-Methylquinazolin-2-yl)methyl]-3-methyl-7-(2-butin-1-yl)-8-(3-(R)-aminopiperidin-1-yl)-xanthine

1h-purine-2,6-dione, 8-[(3r)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-

270L120

3X29ZEJ4R2

668270-12-0

8-[(3R)-3-Amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-1H-purine-2,6-dione

8-[(3R)-3-Amino-1-piperidinyl]-7-(2-butynyl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-1H-purine-2,6-dione

8-[(3R)-3-amino-1-piperidyl]-7-but-2-ynyl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione

8-[(3R)-3-aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1H-purine-2,6-dione

8-[(3r)-3-Aminopiperidin-1-Yl]-7-But-2-Yn-1-Yl-3-Methyl-1-[(4-Methylquinazolin-2-Yl)methyl]-3,7-Dihydro-1h-Purine-2,6-Dione

8-[(3R)-3-aminopiperidin-1-yl]-7-but-2-ynyl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione

AB0008009

AB01563307_01

AB01563307_03

AB1008521

AC-8761

ACN-028592

AJ-45731

AK134946

AKOS015951179

AKOS015995251

AN-2539

API0007204

AX8161416

BCP9000854

BCPP000185

BDBM50228403

BI 1356

BI 1356BS

BI-1356

BI-1356-BS

BS 1356 BS

BS-1356-BS

C25H28N8O2

CHEBI:68610

CHEMBL237500

CS-0637

D02EYG

D09566

DB08882

EX-A076

FT-0670793

GP5216

GTPL6318

HY-10284

J-519354

KB-78157

KS-00000765

Linagliptin (BI-1356)

Linagliptin (JAN/USAN/INN)

Linagliptin [USAN:INN:JAN]

Linagliptin S-Isomer

LTXREWYXXSTFRX-QGZVFWFLSA-N

MLS006010217

MolPort-021-783-260

NCGC00346655-01

Ondero

Ondero (TN)

Q-4491

RL04547

s3031

SC-66358

SC-83230

SCHEMBL160188

SMR004701306

Tradjenta

Tradjenta (TN)

Trajenta

Trazenta

UNII-3X29ZEJ4R2

X1062

ZINC3820029

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	201281-002	Jan 30, 2012		RX	Yes	No			Y
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012		RX	Yes	No
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012		RX	Yes	No			Y
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011		RX	Yes	Yes

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

International Patents for linagliptin

Country	Document Number	Estimated Expiration
European Patent Office	2990037
Eurasian Patent Organization	024251
Portugal	2015754
Ukraine	100221

Supplementary Protection Certificates for linagliptin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2011013	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
90035-4	Sweden		PRODUCT NAME: LINAGLIPTIN, DESS ENANTIOMERER OCH SALTER DAERAV; REG. NO/DATE: EU/1/11/707/001 20110824
2017014	Lithuania		PRODUCT NAME: EMPAGLIFLOZINO IR LINAGLIPTINO DERINYS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1146/001 - EU/1/16/1146/018 20161111
2014044	Lithuania		PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824