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Last Updated: June 24, 2021

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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 eighteen 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.

DrugPatentWatch® 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 2018 were $2.2bn, indicating a strong incentive for generic entry.

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 five 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

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Drug Sales Revenue Trends for TRADJENTA

See drug sales revenues for TRADJENTA

DrugPatentWatch® Estimated 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

Pharmacology for TRADJENTA
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   Try Before You Buy   Try Before You Buy   Try Before You Buy
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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   Try Before You Buy   Try Before You Buy
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011   Try Before You Buy   Try Before You Buy
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011   Try Before You Buy   Try Before You Buy
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011   Try Before You Buy   Try Before You Buy
>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
1532149 PA2011013,C1532149 Lithuania   Try Before You Buy 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
1532149 118 5013-2011 Slovakia   Try Before You Buy PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001 - EU/1/11/707/011 20110824
1084705 CA 2014 00063 Denmark   Try Before You Buy PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070321
0896538 91382 Luxembourg   Try Before You Buy 91382, EXPIRES: 20220424
0896538 300280 Netherlands   Try Before You Buy 300280, 20170424, EXPIRES: 20220320
>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

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