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Fluvastatin sodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for fluvastatin sodium?

Fluvastatin sodium is the generic ingredient in three branded drugs marketed by Teva Pharms, Teva Pharms Usa, Mylan Pharms Inc, and Novartis, 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.

This ingredient has twenty-eight patent family members in nineteen countries.

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

Summary for Generic Name: fluvastatin sodium

Tradenames:3
Patents:2
Applicants:4
NDAs:6
Drug Master File Entries: see list11
Suppliers / Packagers: see list7
Bulk Api Vendors: see list81
Clinical Trials: see list937
Patent Applications: see list2,755
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fluvastatin sodium at DailyMed

Pharmacology for Ingredient: fluvastatin sodium

Tentative approvals for FLUVASTATIN SODIUM

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET, EXTENDED RELEASE; ORAL80MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
FLUVASTATIN SODIUM
fluvastatin sodium
CAPSULE;ORAL090595-001Apr 11, 2012RXNoNo► Subscribe► Subscribe
Teva Pharms
FLUVASTATIN SODIUM
fluvastatin sodium
CAPSULE;ORAL078407-001Jun 12, 2012RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
FLUVASTATIN SODIUM
fluvastatin sodium
CAPSULE;ORAL090595-002Apr 11, 2012RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
FLUVASTATIN SODIUM
fluvastatin sodium
TABLET, EXTENDED RELEASE;ORAL202458-001Sep 11, 2015RXNoNo► Subscribe► Subscribe
Novartis
LESCOL
fluvastatin sodium
CAPSULE;ORAL020261-002Dec 31, 1993RXYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fluvastatin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
LESCOL
fluvastatin sodium
CAPSULE;ORAL020261-001Dec 31, 19935,354,772*PED► Subscribe
Novartis
LESCOL XL
fluvastatin sodium
TABLET, EXTENDED RELEASE;ORAL021192-001Oct 6, 20005,354,772*PED► Subscribe
Novartis
LESCOL XL
fluvastatin sodium
TABLET, EXTENDED RELEASE;ORAL021192-001Oct 6, 20005,356,896*PED► Subscribe
Novartis
LESCOL
fluvastatin sodium
CAPSULE;ORAL020261-002Dec 31, 19935,356,896*PED► Subscribe
Novartis
LESCOL
fluvastatin sodium
CAPSULE;ORAL020261-001Dec 31, 19935,356,896*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: fluvastatin sodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,303,987Pharmaceutical compositions comprising fluvastatin► Subscribe
6,432,447 Organic compounds► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: fluvastatin sodium

Country Document Number Estimated Expiration
MexicoPA02010136► Subscribe
Japan2003530422► Subscribe
South Africa200208163► Subscribe
China1422151► Subscribe
Australia2001262196► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FLUVASTATIN SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022Belgium► SubscribePRODUCT NAME: FLUVASTATINE SODIQUE; NAT. REGISTRATION NO/DATE: 151 IS 207 F 4 19960409; FIRST REGISTRATION: GB 0101/0360 19930823
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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