FLUVASTATIN SODIUM Drug Patent Profile
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When do Fluvastatin Sodium patents expire, and when can generic versions of Fluvastatin Sodium launch?
Fluvastatin Sodium is a drug marketed by Mylan Pharms Inc, Teva Pharms, Beijing, Norvium Bioscience, and Teva Pharms Usa. and is included in five NDAs.
The generic ingredient in FLUVASTATIN SODIUM is fluvastatin sodium. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fluvastatin Sodium
A generic version of FLUVASTATIN SODIUM was approved as fluvastatin sodium by MYLAN PHARMS INC on April 11th, 2012.
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Questions you can ask:
- What is the 5 year forecast for FLUVASTATIN SODIUM?
- What are the global sales for FLUVASTATIN SODIUM?
- What is Average Wholesale Price for FLUVASTATIN SODIUM?
Summary for FLUVASTATIN SODIUM
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 137 |
| Clinical Trials: | 5 |
| Patent Applications: | 3,758 |
| Drug Prices: | Drug price information for FLUVASTATIN SODIUM |
| What excipients (inactive ingredients) are in FLUVASTATIN SODIUM? | FLUVASTATIN SODIUM excipients list |
| DailyMed Link: | FLUVASTATIN SODIUM at DailyMed |
Recent Clinical Trials for FLUVASTATIN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
| Federal University of São Paulo | Phase 4 |
| Novartis Pharmaceuticals | Phase 4 |
Pharmacology for FLUVASTATIN SODIUM
| Drug Class | HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for FLUVASTATIN SODIUM
Paragraph IV (Patent) Challenges for FLUVASTATIN SODIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LESCOL | Capsules | fluvastatin sodium | 20 mg and 40 mg | 020261 | 1 | 2008-06-04 |
| LESCOL XL | Extended-release Tablets | fluvastatin sodium | 80 mg | 021192 | 1 | 2007-03-15 |
US Patents and Regulatory Information for FLUVASTATIN SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Pharms Inc | FLUVASTATIN SODIUM | fluvastatin sodium | CAPSULE;ORAL | 090595-001 | Apr 11, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | FLUVASTATIN SODIUM | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 079011-001 | Jan 27, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms | FLUVASTATIN SODIUM | fluvastatin sodium | CAPSULE;ORAL | 078407-002 | Jun 12, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Pharms Inc | FLUVASTATIN SODIUM | fluvastatin sodium | CAPSULE;ORAL | 090595-002 | Apr 11, 2012 | AB | RX | No | Yes | ⤷ 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 |
