Linagliptin - Generic Drug Details

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What are the generic sources for linagliptin and what is the scope of patent protection?

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.

Linagliptin has three hundred and twenty-three 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 four tentative approvals for this compound.

Summary for linagliptin

International Patents:	323
US Patents:	18
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	19
Suppliers / Packagers:	3
Bulk Api Vendors:	72
Clinical Trials:	124
Patent Applications:	495
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
Hospital Regional de Alta Especialidad del Bajio	Phase 3
Universidad de Guanajuato	Phase 3
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Phase 2

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Recent Litigation for linagliptin

Identify potential future generic entrants

District Court Litigation

Case Name	Date
BOEHRINGER INGELHEIM PHARMACEUTICALS INC. v. SUN PHARMACEUTICAL INDUSTRIES LTD	2016-03-29
Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.	2015-08-25
BOEHRINGER INGELHEIM PHARMACEUTICALS INC. v. HEC PHARM CO., LTD.	2015-08-04

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PTAB Litigation

Petitioner	Date
Mylan Pharmaceuticals Inc.	2016-08-10
Mylan Pharmaceuticals Inc.	2016-08-10

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Generic filers with tentative approvals for LINAGLIPTIN

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	5MG	TABLET;ORAL
Start Trial	Start Trial	2.5MG;1GM	TABLET;ORAL
Start Trial	Start 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

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-butynyl)-3,7-dihydro-3-methyl-1-((4-methyl-2-quinazolinyl)methyl)-
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]-
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]-
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
AKOS015951179
AKOS015995251
AN-2539
API0007204
AS-35080
AX8161416
BCP02462
BCP9000854
BCPP000185
BDBM50228403
BI 1356
BI 1356BS
BI-1356
BI-1356-BS
BS 1356 BS
BS-1356-BS
C25H28N8O2
CHEBI:68610
CHEMBL237500
CS-0637
D09566
DB08882
EX-A076
FT-0670793
GP5216
GTPL6318
HSDB 8204
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
Q-4491
RL04547
s3031
SC-66358
SC-83230
SCHEMBL160188
SMR004701306
SW219813-1
Tradjenta
Tradjenta (TN)
Trajenta
Trazenta
UNII-3X29ZEJ4R2
X1062
ZINC3820029

Paragraph IV (Patent) Challenges for LINAGLIPTIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
TRADJENTA	TABLET;ORAL	linagliptin	201280	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		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012		RX	Yes	No	Start Trial	Start Trial				Start Trial
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	Start Trial	Start Trial				Start 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	Start Trial	Start Trial
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	Start Trial	Start Trial
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for linagliptin

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Country	Patent Number	Estimated Expiration
Germany	10238243	Start Trial
Hong Kong	1081552	Start Trial
South Korea	20090047560	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for linagliptin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	PA2012022	Lithuania	Start Trial	PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1532149	C300569	Netherlands	Start Trial	PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
1532149	CA 2011 00030	Denmark	Start Trial
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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