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Last Updated: February 26, 2021

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Telmisartan - Generic Drug Details

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What are the generic drug 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 are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Telmisartan has eighty-eight patent family members in thirty-eight countries.

There are thirty-nine drug master file entries for telmisartan. Twenty-three 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
Queens Medical CenterPhase 2
Cairo UniversityN/A
George Medicines PTY LimitedPhase 3

See all telmisartan clinical trials

Generic filers with tentative approvals for TELMISARTAN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial80MG; 25MGTABLET; ORAL
  Start Trial  Start Trial80MG; 12.5MGTABLET; ORAL
  Start Trial  Start 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
Mylan TELMISARTAN telmisartan TABLET;ORAL 202397-002 Jul 7, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Prinston Inc TELMISARTAN telmisartan TABLET;ORAL 207882-003 May 3, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998 AB 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 telmisartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-003 Apr 4, 2000   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-001 Nov 10, 1998   Start Trial   Start Trial
Boehringer Ingelheim MICARDIS telmisartan TABLET;ORAL 020850-002 Nov 10, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for telmisartan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0502314 C990007 Netherlands   Start Trial PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT; REGISTRATION NO/DATE: EU/1/98/089/001-EU/1/98/089/010 19981211
0502314 24/2002 Austria   Start 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 23/1999 Austria   Start 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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