Telmisartan - Generic Drug Details
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
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, Amneal Pharms, Aurobindo Pharma, 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-five suppliers are listed for this compound.
Summary for telmisartan
International Patents: | 41 |
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 17 |
NDAs: | 17 |
Drug Master File Entries: | 39 |
Finished Product Suppliers / Packagers: | 25 |
Raw Ingredient (Bulk) Api Vendors: | 143 |
Clinical Trials: | 269 |
Patent Applications: | 7,615 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for telmisartan |
Drug Sales Revenues: | Drug sales revenues for telmisartan |
What excipients (inactive ingredients) are in telmisartan? | telmisartan excipients list |
DailyMed Link: | telmisartan at DailyMed |
Recent Clinical Trials for telmisartan
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
HK inno.N Corporation | Phase 1 |
Michael Smith Foundation for Health Research | Early Phase 1 |
Heart and Stroke Foundation of Canada | Early Phase 1 |
Pharmacology for telmisartan
Drug Class | Angiotensin 2 Receptor Blocker |
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for telmisartan
Paragraph IV (Patent) Challenges for TELMISARTAN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MICARDIS | Tablets | telmisartan | 20 mg, 40 mg and 80 mg | 020850 | 1 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd V | TELMISARTAN | telmisartan | TABLET;ORAL | 205901-002 | Apr 22, 2016 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Sandoz Inc | TELMISARTAN | telmisartan | TABLET;ORAL | 203867-001 | Nov 3, 2014 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Hisun Pharm Hangzhou | TELMISARTAN | telmisartan | TABLET;ORAL | 207843-002 | Feb 19, 2019 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 | 020850-002 | Nov 10, 1998 | See Plans and Pricing | See Plans and Pricing |
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-003 | Apr 4, 2000 | See Plans and Pricing | See Plans and Pricing |
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-002 | Nov 10, 1998 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for telmisartan
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim International GmbH | Micardis | telmisartan | EMEA/H/C/000209 HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;type-2 diabetes mellitus with documented target-organ damage. |
Authorised | no | no | no | 1998-12-16 | |
Krka, d.d., Novo mesto | Tolura | telmisartan | EMEA/H/C/001196 HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease or peripheral arterial disease) or;type 2 diabetes mellitus with documented target organ damage. |
Authorised | yes | no | no | 2010-06-04 | |
Teva B.V. | Telmisartan Teva Pharma | telmisartan | EMEA/H/C/002511 Treatment of essential hypertension in adults. |
Authorised | yes | no | no | 2011-10-03 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for telmisartan
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 100572080 | See Plans and Pricing | |
Australia | 9453398 | See Plans and Pricing | |
South Korea | 20050085966 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for telmisartan
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0502314 | C300095 | Netherlands | See Plans and Pricing | 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 | SPC/GB11/010 | United Kingdom | See Plans and Pricing | PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK |
0502314 | 23/1999 | Austria | See Plans and Pricing | 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 |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:






Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.