telmisartan - Profile
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What are the generic sources for telmisartan and what is the scope of freedom to operate?
Telmisartan
is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Alembic, Amneal Pharms, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Inventia, Jubilant Generics, Macleods Pharms Ltd, Mankind Pharma, Micro Labs, Mylan, Prinston Inc, Sandoz, Torrent, and Zydus Pharms, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.There is one tentative approval for this compound.
Summary for telmisartan
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 19 |
| NDAs: | 19 |
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.
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
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 | 6,358,986 | ⤷ Start Trial |
| Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-002 | Nov 10, 1998 | 8,003,679 | ⤷ Start Trial |
| Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-003 | Apr 4, 2000 | 5,591,762 | ⤷ Start Trial |
| Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-002 | Nov 10, 1998 | 7,998,953 | ⤷ Start Trial |
| Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-001 | Nov 10, 1998 | 5,591,762 | ⤷ Start Trial |
| Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-001 | Nov 10, 1998 | 6,358,986 | ⤷ Start Trial |
| Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-003 | Apr 4, 2000 | 6,358,986 | ⤷ Start Trial |
| >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/000209HypertensionTreatment 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/001196HypertensionTreatment 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/002511Treatment of essential hypertension in adults. | Authorised | yes | no | no | 2011-10-03 | |
| Teva B.V. | Telmisartan Teva | telmisartan | EMEA/H/C/001146Treatment of essential hypertension in adults | Withdrawn | yes | no | no | 2010-01-25 | |
| Actavis Group PTC ehf | Telmisartan Actavis | telmisartan | EMEA/H/C/001168HypertensionTreatment 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 | yes | no | no | 2010-09-29 | |
| Bayer AG | Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) | telmisartan | EMEA/H/C/000211HypertensionTreatment 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 | |
| Bayer AG | Pritor | telmisartan | EMEA/H/C/000210HypertensionTreatment 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 | 1998-12-11 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
Telmisartan: Investment Analysis, Market Dynamics, and Financial Trajectory
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