Fluvastatin sodium - Generic Drug Details
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What are the generic drug sources for fluvastatin sodium and what is the scope of patent protection?
Fluvastatin sodium
is the generic ingredient in three branded drugs marketed by Mylan Pharms Inc, Teva Pharms, Novartis, Beijing, Mylan, Teva Pharms Usa, and Sandoz, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for fluvastatin sodium. Six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for fluvastatin sodium
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 7 |
NDAs: | 7 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 137 |
Clinical Trials: | 5 |
Patent Applications: | 6,095 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
Generic filers with tentative approvals for FLUVASTATIN SODIUM
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 80MG | TABLET, EXTENDED RELEASE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | LESCOL | fluvastatin sodium | CAPSULE;ORAL | 020261-001 | Dec 31, 1993 | DISCN | Yes | 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 | |||
Sandoz | LESCOL XL | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 021192-001 | Oct 6, 2000 | AB | RX | Yes | 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 |
Expired US Patents for fluvastatin sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | LESCOL XL | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 021192-001 | Oct 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | LESCOL | fluvastatin sodium | CAPSULE;ORAL | 020261-001 | Dec 31, 1993 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | LESCOL XL | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 021192-001 | Oct 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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