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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
Bulk Api Vendors: see list52
Clinical Trials: see list6
Patent Applications: see list5,211
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:amprenavir at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
AGENERASE
amprenavir
CAPSULE;ORAL021007-002Apr 15, 1999DISCNNoNo6,730,679► subscribeY ► subscribe
Glaxosmithkline
AGENERASE
amprenavir
CAPSULE;ORAL021007-001Apr 15, 1999DISCNNoNo6,730,679► subscribeY ► subscribe
Glaxosmithkline
AGENERASE
amprenavir
SOLUTION;ORAL021039-001Apr 15, 1999DISCNYesNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: amprenavir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
AGENERASE
amprenavir
SOLUTION;ORAL021039-001Apr 15, 19995,646,180► subscribe
Glaxosmithkline
AGENERASE
amprenavir
CAPSULE;ORAL021007-001Apr 15, 19995,585,397► subscribe
Glaxosmithkline
AGENERASE
amprenavir
CAPSULE;ORAL021007-002Apr 15, 19995,585,397► subscribe
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International Patent Family for Ingredient: amprenavir

Country Document Number Estimated Expiration
Bulgaria102838► subscribe
World Intellectual Property Organization (WIPO)9735587► subscribe
Uruguay25926► 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: AMPRENAVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0015France► subscribePRODUCT NAME: FOSAMPRENAVIR CALCIQUE; REG. NO/DATE: EU/1/07/282/001-002 20040712
01C/014Belgium► subscribePRODUCT NAME: AMPRENAVIR; NATL. REGISTRATION NO/DATE: EU/1/00/148/001 20001020; FIRST REGISTRATION: CH 55072 01 19990512
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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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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