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Serving leading biopharmaceutical companies globally:

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Chinese Patent Office
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Generated: December 18, 2017

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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 fluvastatin sodium freedom to operate?

Fluvastatin sodium
is the generic ingredient in three branded drugs marketed by Mylan Pharms Inc, Teva Pharms, Novartis, 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 and one supplementary protection certificate in one country.

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

Pharmacology for fluvastatin sodium

Tentative approvals for FLUVASTATIN SODIUM

Applicant Application No. Strength Dosage Form
u► Subscribe80MGTABLET, EXTENDED RELEASE; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva PharmsFLUVASTATIN SODIUMfluvastatin sodiumCAPSULE;ORAL078407-001Jun 12, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva PharmsFLUVASTATIN SODIUMfluvastatin sodiumCAPSULE;ORAL078407-002Jun 12, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
NovartisLESCOL XLfluvastatin sodiumTABLET, EXTENDED RELEASE;ORAL021192-001Oct 6, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
NovartisLESCOLfluvastatin sodiumCAPSULE;ORAL020261-002Dec 31, 1993DISCNYesNo► Subscribe► Subscribe► Subscribe
Mylan Pharms IncFLUVASTATIN SODIUMfluvastatin sodiumCAPSULE;ORAL090595-002Apr 11, 2012ABRXNoYes► Subscribe► Subscribe► Subscribe
Mylan Pharms IncFLUVASTATIN SODIUMfluvastatin sodiumTABLET, EXTENDED RELEASE;ORAL202458-001Sep 11, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
NovartisLESCOLfluvastatin sodiumCAPSULE;ORAL020261-001Dec 31, 1993DISCNYesNo► Subscribe► Subscribe► Subscribe
Teva Pharms UsaFLUVASTATIN SODIUMfluvastatin sodiumTABLET, EXTENDED RELEASE;ORAL079011-001Jan 27, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms IncFLUVASTATIN SODIUMfluvastatin sodiumCAPSULE;ORAL090595-001Apr 11, 2012ABRXNoNo► Subscribe► 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
NovartisLESCOL XLfluvastatin sodiumTABLET, EXTENDED RELEASE;ORAL021192-001Oct 6, 2000► Subscribe► Subscribe
NovartisLESCOLfluvastatin sodiumCAPSULE;ORAL020261-001Dec 31, 1993► Subscribe► Subscribe
NovartisLESCOL XLfluvastatin sodiumTABLET, EXTENDED RELEASE;ORAL021192-001Oct 6, 2000► Subscribe► Subscribe
NovartisLESCOLfluvastatin sodiumCAPSULE;ORAL020261-002Dec 31, 1993► Subscribe► Subscribe
NovartisLESCOLfluvastatin sodiumCAPSULE;ORAL020261-002Dec 31, 1993► Subscribe► Subscribe
NovartisLESCOLfluvastatin sodiumCAPSULE;ORAL020261-001Dec 31, 1993► Subscribe► 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
6,432,447 Organic compounds► Subscribe
8,303,987Pharmaceutical compositions comprising fluvastatin► 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
European Patent Office1272166► Subscribe
Australia6219601► Subscribe
MexicoPA02010136► Subscribe
Russian Federation2297223► Subscribe
Russian Federation2002129570► Subscribe
Israel152077► Subscribe
Canada2403591► Subscribe
South Korea100510856► Subscribe
South Korea20030019332► Subscribe
World Intellectual Property Organization (WIPO)0178680► 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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Serving leading biopharmaceutical companies globally:

Argus Health
Dow
Healthtrust
Queensland Health
AstraZeneca
McKinsey
Johnson and Johnson
Federal Trade Commission
Farmers Insurance
Baxter

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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