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Last Updated: November 22, 2019

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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.

Recent Clinical Trials for linagliptin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hospital Regional de Alta Especialidad del BajioPhase 3
Universidad de GuanajuatoPhase 3
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Phase 2

See all linagliptin clinical trials

Recent Litigation for linagliptin

Identify potential future generic entrants

District Court Litigation
Case NameDate
BOEHRINGER INGELHEIM PHARMACEUTICALS INC. v. SUN PHARMACEUTICAL INDUSTRIES LTD2016-03-29
Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.2015-08-25
BOEHRINGER INGELHEIM PHARMACEUTICALS INC. v. HEC PHARM CO., LTD.2015-08-04

See all linagliptin litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2016-08-10
Mylan Pharmaceuticals Inc.2016-08-10

See all linagliptin litigation

Generic filers with tentative approvals for LINAGLIPTIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial5MGTABLET;ORAL
  Start Trial  Start Trial2.5MG;1GMTABLET;ORAL
  Start Trial  Start Trial2.5MG;850MGTABLET;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
Medical Subject Heading (MeSH) Categories for linagliptin
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

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

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

Supplementary Protection Certificates for linagliptin

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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McKinsey
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Dow

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