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Last Updated: February 26, 2021

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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, Mylan, and Teva Pharms Usa, and is included in six NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fluvastatin sodium has twenty-eight patent family members in nineteen countries.

There are eleven drug master file entries for fluvastatin sodium. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for FLUVASTATIN SODIUM

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Recent Clinical Trials for FLUVASTATIN SODIUM

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

SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of 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
  Start Trial  Start Trial80MGTABLET, 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
Paragraph IV (Patent) Challenges for FLUVASTATIN SODIUM
Tradename Dosage Ingredient NDA Submissiondate
LESCOL CAPSULE;ORAL fluvastatin sodium 020261 2008-06-04
LESCOL XL TABLET, EXTENDED RELEASE;ORAL fluvastatin sodium 021192 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
Teva Pharms FLUVASTATIN SODIUM fluvastatin sodium CAPSULE;ORAL 078407-002 Jun 12, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc FLUVASTATIN SODIUM fluvastatin sodium CAPSULE;ORAL 090595-001 Apr 11, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-002 Dec 31, 1993 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc FLUVASTATIN SODIUM fluvastatin sodium CAPSULE;ORAL 090595-002 Apr 11, 2012 AB RX No Yes   Start Trial   Start Trial   Start Trial
Teva Pharms FLUVASTATIN SODIUM fluvastatin sodium CAPSULE;ORAL 078407-001 Jun 12, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-002 Dec 31, 1993   Start Trial   Start Trial
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000   Start Trial   Start Trial
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000   Start Trial   Start Trial
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000   Start Trial   Start Trial
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-001 Dec 31, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FLUVASTATIN SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0114027 96C0022 Belgium   Start Trial PRODUCT NAME: FLUVASTATINE SODIQUE; NAT. REGISTRATION NO/DATE: 151 IS 207 F 4 19960409; FIRST REGISTRATION: GB 0101/0360 19930823
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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