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Lovastatin - Generic Drug Details

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

Lovastatin is the generic ingredient in three branded drugs marketed by Sandoz, Covis Pharma Sarl, Sun Pharm Inds, Actavis Elizabeth, Mylan, Merck, Apotex Inc, Teva, Carlsbad, and Lupin, and is included in twelve NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-three patent family members in twelve countries.

There are thirty-three drug master file entries for lovastatin. Forty-two suppliers are listed for this compound.

Summary for Generic Name: lovastatin

Tradenames:3
Patents:4
Applicants:10
NDAs:12
Drug Master File Entries: see list33
Suppliers / Packagers: see list42
Bulk Api Vendors: see list66
Clinical Trials: see list17
Patent Applications: see list6,311
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lovastatin at DailyMed

Pharmacology for Ingredient: lovastatin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva
LOVASTATIN
lovastatin
TABLET;ORAL075551-003Dec 17, 2001RXNoNo► Subscribe► Subscribe
Covis Pharma Sarl
ALTOPREV
lovastatin
TABLET, EXTENDED RELEASE;ORAL021316-002Jun 26, 2002RXYesNo6,080,778► Subscribe ► Subscribe
Apotex Inc
LOVASTATIN
lovastatin
TABLET;ORAL077748-001Feb 28, 2007RXNoNo► Subscribe► Subscribe
Mylan
LOVASTATIN
lovastatin
TABLET;ORAL075451-001Dec 17, 2001RXNoNo► Subscribe► Subscribe
Merck
MEVACOR
lovastatin
TABLET;ORAL019643-004Dec 14, 1988DISCNYesNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: lovastatin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
MEVACOR
lovastatin
TABLET;ORAL019643-002Mar 28, 19914,231,938*PED► Subscribe
Merck
MEVACOR
lovastatin
TABLET;ORAL019643-004Dec 14, 19884,231,938*PED► Subscribe
Merck
MEVACOR
lovastatin
TABLET;ORAL019643-003Aug 31, 19874,231,938*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: lovastatin

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
8,679,534HMG-CoA reductase inhibitor extended release formulation► Subscribe
6,440,387 Methods for determining risk of Alzheimer's disease► 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: lovastatin

Country Document Number Estimated Expiration
Japan2002507564► Subscribe
Australia768950► Subscribe
World Intellectual Property Organization (WIPO)0134123► Subscribe
Australia759257► Subscribe
New Zealand530584► 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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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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