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Amprenavir - Generic Drug Details

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Amprenavir is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty patent family members in forty countries.

There are five drug master file entries for amprenavir.

Summary for Generic Name: amprenavir

Tradenames:1
Patents:1
Applicants:1
NDAs:2
Drug Master File Entries: see list5
Formulation / Manufacturing:see details

Clinical Trials for: amprenavir

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
AGENERASE
amprenavir
CAPSULE;ORAL021007-002Apr 15, 1999DISCNNo6,730,679<disabled>Y <disabled>
Glaxosmithkline
AGENERASE
amprenavir
CAPSULE;ORAL021007-001Apr 15, 1999DISCNNo6,730,679<disabled>Y <disabled>
Glaxosmithkline
AGENERASE
amprenavir
SOLUTION;ORAL021039-001Apr 15, 1999DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: amprenavir

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
AGENERASE
amprenavir
SOLUTION;ORAL021039-001Apr 15, 19995,646,180<disabled>
Glaxosmithkline
AGENERASE
amprenavir
SOLUTION;ORAL021039-001Apr 15, 19995,723,490<disabled>
Glaxosmithkline
AGENERASE
amprenavir
CAPSULE;ORAL021007-001Apr 15, 19995,585,397<disabled>
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International Patent Family for Ingredient: amprenavir

Country Document Number Estimated Expiration
China1225587<disabled in preview>
Ukraine67723<disabled in preview>
Bulgaria64457<disabled in preview>
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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: AMPRENAVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
01C/014Belgium<disabled>PRODUCT NAME: AMPRENAVIR; NATL. REGISTRATION NO/DATE: EU/1/00/148/001 20001020; FIRST REGISTRATION: CH 55072 01 19990512
C/GB08/018United Kingdom<disabled>PRODUCT 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
2008006Lithuania<disabled>PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
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