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, Mylan, 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.
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: | 3,696 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Federal University of São Paulo | Phase 4 |
Fundação de Amparo à Pesquisa do Estado de 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 |