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Fosamprenavir calcium - Generic Drug Details

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

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 fourteen 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:3
Applicants:2
NDAs:3
Drug Master File Entries: see list4
Suppliers / Packagers: see list3
Bulk Api Vendors: see list28
Clinical Trials: see list734
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fosamprenavir calcium at DailyMed

Tentative approvals for FOSAMPRENAVIR CALCIUM

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET;ORAL700MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
FOSAMPRENAVIR CALCIUM
fosamprenavir calcium
TABLET;ORAL204060-001Apr 15, 2016RXNoNo► Subscribe► Subscribe
Viiv Hlthcare
LEXIVA
fosamprenavir calcium
TABLET;ORAL021548-001Oct 20, 2003RXYesYes6,514,953*PED► SubscribeY► Subscribe
Viiv Hlthcare
LEXIVA
fosamprenavir calcium
SUSPENSION;ORAL022116-001Jun 14, 2007RXYesYes6,436,989*PED► SubscribeY► Subscribe
Viiv Hlthcare
LEXIVA
fosamprenavir calcium
TABLET;ORAL021548-001Oct 20, 2003RXYesYes6,436,989*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
7,592,368Sulphonamide derivatives as prodrugs of aspartyl protease inhibitors► Subscribe
6,838,474 Sulphonamide derivatives as prodrugs of aspartyl protease inhibitors► Subscribe
6,559,137 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
Slovenia0933372► Subscribe
Bulgaria104631► Subscribe
Ukraine72733► Subscribe
Luxembourg91426► Subscribe
Czech Republic20010219► 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
0933372/01Switzerland► SubscribePRODUCT NAME: FOSAMPRENAVIR; REGISTRATION NUMBER/DATE: SWISSMEDIC 56706 17.03.2005
2008006,C0933372Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
2008 00027Denmark► Subscribe
2008006Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
C/GB08/018United Kingdom► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
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