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Last Updated: June 2, 2020

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TRADJENTA Drug Profile


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When do Tradjenta patents expire, and what generic alternatives are available?

Tradjenta is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and seven patent family members in forty-five countries.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the linagliptin profile page.

US ANDA Litigation and Generic Entry Outlook for Tradjenta

Tradjenta was eligible for patent challenges on May 20, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 26, 2025. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $1.3bn, indicating a strong incentive for generic entry (peak sales were $2.0bn in 2016).

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are four tentative approvals for the generic drug (linagliptin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for TRADJENTA
Drug Prices for TRADJENTA

See drug prices for TRADJENTA

Drug Sales Revenue Trends for TRADJENTA

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Generic Entry Opportunity Date for TRADJENTA
Generic Entry Date for TRADJENTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TRADJENTA

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

SponsorPhase
University of MiamiPhase 4
EMSPhase 3
M.H.H. KramerPhase 4

See all TRADJENTA clinical trials

Recent Litigation for TRADJENTA

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 TRADJENTA litigation

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

See all TRADJENTA litigation

Pharmacology for TRADJENTA
Synonyms for TRADJENTA
(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]-
270L120
3X29ZEJ4R2
668270-12-0
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-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
AKOS015951179
AKOS015995251
API0007204
AS-35080
AX8161416
BCP02462
BCP9000854
BCPP000185
BDBM50228403
BI 1356
BI-1356
BI-1356-BS
BI-1356BS
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
KS-00000765
Linagliptin
Linagliptin (BI-1356)
Linagliptin (JAN/USAN/INN)
Linagliptin [USAN:INN:JAN]
Linagliptin S-Isomer
linagliptin-bi-1356
Linagliptin; (R)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1H-purine-2,6(3H,7H)-dione
LTXREWYXXSTFRX-QGZVFWFLSA-N
MLS006010217
NCGC00346655-01
Ondero
Q-4491
Q909745
s3031
SC-66358
SC-83230
SCHEMBL160188
SMR004701306
SW219813-1
Tradjenta (TN)
Trajenta
Trazenta
UNII-3X29ZEJ4R2
X1062
ZINC3820029
Paragraph IV (Patent) Challenges for TRADJENTA
Tradename Dosage Ingredient NDA Submissiondate
TRADJENTA TABLET;ORAL linagliptin 201280 2015-05-04

US Patents and Regulatory Information for TRADJENTA

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 TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 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 TRADJENTA

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
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 TRADJENTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 CA 2014 00062 Denmark   Start Trial PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001
1084705 PA2014043 Lithuania   Start Trial PRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
1084705 C01084705/01 Switzerland   Start Trial PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
1532149 118 5013-2011 Slovakia   Start Trial PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001 - EU/1/11/707/011 20110824
1532149 92128 Luxembourg   Start Trial PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Colorcon
Merck
Dow
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.