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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 |
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 |
Generic filers with tentative approvals for TELMISARTAN
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 80MG; 25MG | TABLET; ORAL |
Start Trial | Start Trial | 80MG; 12.5MG | TABLET; ORAL |
Start Trial | Start Trial | 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 | 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 |
International Patents for telmisartan
Country | Patent Number | Estimated Expiration |
---|---|---|
Peru | 13622000 | Start Trial |
European Patent Office | 1559424 | Start Trial |
China | 1279606 | Start Trial |
>Country | >Patent Number | >Estimated 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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