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Generated: August 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 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.

Fluvastatin sodium 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:1
Applicants:4
NDAs:6
Drug Master File Entries: see list11
Suppliers / Packagers: see list7
Bulk Api Vendors: see list81
Clinical Trials: see list2,414
Patent Applications: see list4,712
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. Strength Dosage Form
► Subscribe► 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 Pharms
FLUVASTATIN SODIUM
fluvastatin sodium
CAPSULE;ORAL078407-002Jun 12, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
FLUVASTATIN SODIUM
fluvastatin sodium
TABLET, EXTENDED RELEASE;ORAL202458-001Sep 11, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
LESCOL
fluvastatin sodium
CAPSULE;ORAL020261-001Dec 31, 1993DISCNYesNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
FLUVASTATIN SODIUM
fluvastatin sodium
CAPSULE;ORAL090595-002Apr 11, 2012ABRXNoYes► Subscribe► Subscribe► Subscribe
Novartis
LESCOL XL
fluvastatin sodium
TABLET, EXTENDED RELEASE;ORAL021192-001Oct 6, 2000ABRXYesYes► Subscribe► SubscribeY► 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 XL
fluvastatin sodium
TABLET, EXTENDED RELEASE;ORAL021192-001Oct 6, 2000► Subscribe► Subscribe
Novartis
LESCOL
fluvastatin sodium
CAPSULE;ORAL020261-001Dec 31, 1993► Subscribe► Subscribe
Novartis
LESCOL
fluvastatin sodium
CAPSULE;ORAL020261-002Dec 31, 1993► Subscribe► Subscribe
Novartis
LESCOL
fluvastatin sodium
CAPSULE;ORAL020261-001Dec 31, 1993► Subscribe► Subscribe
Novartis
LESCOL
fluvastatin sodium
CAPSULE;ORAL020261-002Dec 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
Singapore160185► Subscribe
European Patent Office1272166► Subscribe
Poland356904► Subscribe
Brazil0109943► Subscribe
New Zealand521441► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Queensland Health
Boehringer Ingelheim
UBS
Cipla
Express Scripts
Farmers Insurance
Accenture
Johnson and Johnson
Novartis
Mallinckrodt

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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