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, Norvium Bioscience, 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-six 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.
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Questions you can ask:
- What is the 5 year forecast for SIMVASTATIN?
- What are the global sales for SIMVASTATIN?
- What is Average Wholesale Price for SIMVASTATIN?
Summary for SIMVASTATIN
| US Patents: | 0 |
| Applicants: | 16 |
| NDAs: | 16 |
| Finished Product Suppliers / Packagers: | 34 |
| Raw Ingredient (Bulk) Api Vendors: | 113 |
| Clinical Trials: | 583 |
| Drug Prices: | Drug price information for SIMVASTATIN |
| Drug Sales Revenues: | Drug sales revenues for SIMVASTATIN |
| DailyMed Link: | SIMVASTATIN at DailyMed |
See drug prices for SIMVASTATIN
Recent Clinical Trials for SIMVASTATIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| International Bio service | Phase 1 |
| State University of New York - Downstate Medical Center | Phase 1/Phase 2 |
| United States Department of Defense | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ivax Sub Teva Pharms | SIMVASTATIN | simvastatin | TABLET;ORAL | 076052-003 | Jun 23, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hetero Labs Ltd Iii | SIMVASTATIN | simvastatin | TABLET;ORAL | 200895-003 | Nov 25, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Micro Labs | SIMVASTATIN | simvastatin | TABLET;ORAL | 090383-001 | Sep 16, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Oxford Pharms | SIMVASTATIN | simvastatin | TABLET;ORAL | 078735-002 | Aug 30, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin | SIMVASTATIN | simvastatin | TABLET;ORAL | 078103-001 | May 11, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
