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Fosamprenavir calcium - Generic Drug Details

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Fosamprenavir calcium is the generic ingredient in two branded drugs marketed by Viiv Hlthcare and Mylan Pharms Inc, and is included in three NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and thirteen patent family members in fifty-three countries.

There are four drug master file entries for fosamprenavir calcium. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: fosamprenavir calcium

Tradenames:2
Patents:2
Applicants:2
NDAs:3
Drug Master File Entries: see list4
Suppliers / Packaging: see list3
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices

Tentative approvals for FOSAMPRENAVIR CALCIUM

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL700MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare
LEXIVA
fosamprenavir calcium
SUSPENSION;ORAL022116-001Jun 14, 2007RXYes6,436,989*PED► subscribeY► subscribe
Viiv Hlthcare
LEXIVA
fosamprenavir calcium
TABLET;ORAL021548-001Oct 20, 2003RXYes► subscribe► subscribe
Viiv Hlthcare
LEXIVA
fosamprenavir calcium
TABLET;ORAL021548-001Oct 20, 2003RXYes6,436,989*PED► subscribeY► subscribe
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Non-Orange Book Patents for Generic Ingredient: fosamprenavir calcium

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
6,559,137 Sulphonamide derivatives as prodrugs of aspartyl protease inhibitors► subscribe
7,592,368Sulphonamide derivatives as prodrugs of aspartyl protease inhibitors► subscribe
6,838,474 Sulphonamide derivatives as prodrugs of aspartyl protease inhibitors► 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: fosamprenavir calcium

Country Document Number Estimated Expiration
Germany69838903► subscribe
Panama8477801► subscribe
Czech Republic300447► 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: FOSAMPRENAVIR CALCIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008006Lithuania► subscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
4Finland► subscribe
0933372/01Switzerland► subscribePRODUCT NAME: FOSAMPRENAVIR; REGISTRATION NUMBER/DATE: SWISSMEDIC 56706 17.03.2005
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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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