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Last Updated: October 26, 2021

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Telmisartan - Generic Drug Details

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

Telmisartan is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Celltrion, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Inventia, Jubilant Generics, Micro Labs, Mylan, Prinston Inc, Sandoz Inc, Torrent, and Zydus Pharms, and is included in seventeen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Telmisartan has forty-one patent family members in eighteen countries.

There are thirty-nine drug master file entries for telmisartan. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for telmisartan

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Drug Sales Revenue Trends for telmisartan

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Recent Clinical Trials for telmisartan

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

SponsorPhase
PACCI ProgramPhase 2/Phase 3
Centre MurazPhase 2/Phase 3
University of BordeauxPhase 2/Phase 3

See all telmisartan clinical trials

Generic filers with tentative approvals for TELMISARTAN
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial80MG; 25MGTABLET; ORAL
⤷  Free Forever Trial⤷  Free Forever Trial80MG; 12.5MGTABLET; ORAL
⤷  Free Forever Trial⤷  Free Forever Trial40MG; 12.5MGTABLET; 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 telmisartan
Paragraph IV (Patent) Challenges for TELMISARTAN
Tradename Dosage Ingredient NDA Submissiondate
MICARDIS TABLET;ORAL telmisartan 020850 2006-12-26

US Patents and Regulatory Information for telmisartan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant Generics TELMISARTAN telmisartan TABLET;ORAL 204164-001 Aug 22, 2016 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Glenmark Pharms Ltd TELMISARTAN telmisartan TABLET;ORAL 090032-002 Jul 7, 2014 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan TELMISARTAN telmisartan TABLET;ORAL 202397-001 Jul 7, 2014 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Inventia TELMISARTAN telmisartan TABLET;ORAL 205150-001 Oct 30, 2015 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Inventia TELMISARTAN telmisartan TABLET;ORAL 205150-003 Oct 30, 2015 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hetero Labs Ltd V TELMISARTAN telmisartan TABLET;ORAL 205901-003 Apr 22, 2016 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 telmisartan

Supplementary Protection Certificates for telmisartan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0502314 24/2002 Austria ⤷  Free Forever Trial PRODUCT NAME: TELMISARTAN, GEGEBENENFALLS IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE, UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/02/213/001- EU/1/02/213/010 20020419
0502314 SPC/GB02/037 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0502314 C300095 Netherlands ⤷  Free Forever Trial PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0502314 99C0014 Belgium ⤷  Free Forever Trial PRODUCT NAME: TELMISARTAN REGISTRATION NO/DATE: EU/1/98/089/001 / 19981211
0502314 1190006-5.L Sweden ⤷  Free Forever Trial PRODUCT NAME: TELMISARTAN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT, OCH AMLODIPIN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT SAERSKILT AMOLODIPINBESILAT; REG. NO/DATE: EU/1/10/648/001-028 " EESGODKLANDKOD="EG" EESGODKDATUM="2010-10-07" SEGODKNR="EU/1/10/648/001-028 " SEGODKLANDKOD="EG" SEGODKDATUM="2010-10-07" FLAG="L" SPCNR="1190006-5" 20101007
0502314 23/1999 Austria ⤷  Free Forever Trial PRODUCT NAME: TELMISARTAN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/98/089/001-010 19981211; FIRST REGISTRATION: BE K (1998) 4288-DE 19981211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Mallinckrodt
Moodys
McKesson
Boehringer Ingelheim

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