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Details for Patent: 5,519,021

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Patent 5,519,021 protects SUSTIVA and ATRIPLA and is included in three NDAs. There have been zero Paragraph IV challenges on Sustiva and Atripla There are twenty-one tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

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

Summary for Patent: 5,519,021

Title: Benzoxazinones as inhibitors of HIV reverse transcriptase
Abstract:Certain benzoxazinones are useful in the inhibition of HIV reverse transcriptase (including its resistant varieties), the prevention or treatment of infection by HIV and the treatment of AIDS, either as compounds, pharmaceutically acceptable salts, pharmaceutical composition ingredients, whether or not in combination with other antivirals, immunomodulators, antibiotics or vaccines. Methods of treating AIDS and methods of preventing or treating infection by HIV are also described.
Inventor(s): Young; Steven D. (Lansdale, PA), Britcher; Susan F. (Norristown, PA), Payne; Linda S. (Lansdale, PA), Tran; Lekhanh O. (West Chester, PA), Lumma, Jr.; William C. (Pennsburg, PA)
Assignee: Merck & Co., Inc. (Rahway, NJ)
Application Number:08/460,026
Patent Claim Types:
see list of patent claims
Compound; Use; Composition;
Patent PDF download available with subscription

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972Sep 17, 1998RXNo5,519,021*PED<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972Sep 17, 1998DISCNNo5,519,021*PED<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972Sep 17, 1998RXYes5,519,021*PED<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937Jul 12, 2006RXYes5,519,021*PED<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360Feb 1, 2002DISCNNo5,519,021*PED<disabled>
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International Patent Family for Patent: 5,519,021

Country Document Number Publication Date
South Africa9305724Mar 03, 1994
Yugoslavia53093Oct 09, 1996
Yugoslavia49439Mar 03, 2006
World Intellectual Property Organization (WIPO)9403440Feb 17, 1994
World Intellectual Property Organization (WIPO)9520389Aug 03, 1995
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