SIMVASTATIN Drug Patent Profile
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When do Simvastatin patents expire, and what generic alternatives are available?
Simvastatin is a drug marketed by Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Dr Reddys Labs Inc, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Micro Labs, Mylan Pharms Inc, Oxford Pharms, Sun Pharm Inds Ltd, Watson Labs Teva, and Zydus Pharms Usa. and is included in sixteen NDAs.
The generic ingredient in SIMVASTATIN is simvastatin. There are forty drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Simvastatin
A generic version of SIMVASTATIN was approved as simvastatin by AUROBINDO PHARMA on December 20th, 2006.
Summary for SIMVASTATIN
See drug prices for SIMVASTATIN
Recent Clinical Trials for SIMVASTATIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| United States Department of Defense | Early Phase 1 |
| National Cancer Institute, Naples | Phase 2 |
| Ahmad Elheeny | Early Phase 1 |
Pharmacology for SIMVASTATIN
| Drug Class | HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for SIMVASTATIN
Anatomical Therapeutic Chemical (ATC) Classes for SIMVASTATIN
US Patents and Regulatory Information for SIMVASTATIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs Teva | SIMVASTATIN | simvastatin | TABLET;ORAL | 076685-004 | Dec 20, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ivax Sub Teva Pharms | SIMVASTATIN | simvastatin | TABLET;ORAL | 076052-003 | Jun 23, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hetero Labs Ltd Iii | SIMVASTATIN | simvastatin | TABLET;ORAL | 200895-003 | Nov 25, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Micro Labs | SIMVASTATIN | simvastatin | TABLET;ORAL | 090383-001 | Sep 16, 2011 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
