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Serving leading biopharmaceutical companies globally:

Citi
Cantor Fitzgerald
Colorcon
QuintilesIMS
Teva
Fuji
UBS
Daiichi Sankyo
Express Scripts
Johnson and Johnson

Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for Patent: 6,242,003

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Which drugs does patent 6,242,003 protect, and when does it expire?


Patent 6,242,003 protects LESCOL XL and is included in one NDA. There has been one Paragraph IV challenge on Lescol XL.

Protection for LESCOL XL has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

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

Summary for Patent: 6,242,003

Title: Organic compounds
Abstract:An oral dosage form comprising fluvastatin and HPMC, which oral dosage form is color-stable upon prolonged periods of storage.
Inventor(s): Kalb; Oskar Michael (Loerrach, DE), Valazza; Stephen John (Matawan, NJ)
Assignee: Novartis AG (Basel, CH)
Application Number:09/549,222
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form; Use; Process;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Novartis
LESCOL XL
fluvastatin sodium
TABLET, EXTENDED RELEASE;ORAL021192-001Oct 6, 2000ABRXYesYes► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 6,242,003

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 Patent: 6,242,003

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2001262196► Subscribe
Australia6219601► Subscribe
Brazil0109943► Subscribe
Canada2403591► Subscribe
China100457102► Subscribe
China1241545► Subscribe
China1422151► Subscribe
China1720912► Subscribe
Czech Republic20023379► Subscribe
European Patent Office1272166► 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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Serving leading biopharmaceutical companies globally:

Merck
Cipla
Citi
Johnson and Johnson
Accenture
Farmers Insurance
Chinese Patent Office
Healthtrust
Argus Health
Chubb

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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