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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.

Summary for telmisartan

International Patents:	88
US Patents:	3
Tradenames:	2
Applicants:	17
NDAs:	17
Drug Master File Entries:	39
Suppliers / Packagers:	23
Bulk Api Vendors:	121
Clinical Trials:	256
Patent Applications:	6,443
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for telmisartan
Drug Sales Revenues:	Drug sales revenues for telmisartan
DailyMed Link:	telmisartan at DailyMed

See drug prices for telmisartan

See drug sales revenues for telmisartan

Recent Clinical Trials for telmisartan

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

Sponsor	Phase
Queens Medical Center	Phase 2
Cairo University	N/A
George Medicines PTY Limited	Phase 3

See all telmisartan clinical trials

Generic filers with tentative approvals for TELMISARTAN

Applicant	Application No.	Strength	Dosage Form
		80MG; 25MG	TABLET; ORAL
		80MG; 12.5MG	TABLET; ORAL
		40MG; 12.5MG	TABLET; 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

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

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
Prinston Inc	TELMISARTAN	telmisartan	TABLET;ORAL	207882-003	May 3, 2017	AB	RX	No	No
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998	AB	RX	Yes	Yes

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
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-001	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998

International Patents for telmisartan

Country	Patent Number	Estimated Expiration
Peru	13622000
European Patent Office	1559424
China	1279606

Supplementary Protection Certificates for telmisartan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	C990007	Netherlands		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		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		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