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Last Updated: November 21, 2024

FLUVASTATIN SODIUM - Generic Drug Details


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What are the generic 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, Norvium Bioscience, 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
Drug Prices for FLUVASTATIN SODIUM

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Recent Clinical Trials for FLUVASTATIN SODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Novartis PharmaceuticalsPhase 4

See all FLUVASTATIN SODIUM clinical trials

Generic filers with tentative approvals for FLUVASTATIN SODIUM
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up80MGTABLET, 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
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
Sandoz LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000 AB RX Yes Yes ⤷  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
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-002 Dec 31, 1993 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience FLUVASTATIN SODIUM fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 202458-001 Sep 11, 2015 DISCN 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

Expired US Patents for FLUVASTATIN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-001 Dec 31, 1993 ⤷  Sign Up ⤷  Sign Up
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-002 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
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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