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Details for Patent: 7,470,506

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Patent 7,470,506 protects PREZISTA and PREZCOBIX and is included in three NDAs. There has been one Paragraph IV challenge on Prezista. There are three tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

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

Summary for Patent: 7,470,506

Title:Fitness assay and associated methods
Abstract:The present invention provides an assay for determining the biochemical fitness of a biochemical species in a mutant replicating biological entity relative to its predecessor. The present invention further provides a continuous fluorogenic assay for measuring the anti-HIV protease activity of protease inhibitor. The present invention also provides a method of administering a therapeutic compound that reduces the chances of the emergence of drug resistance in therapy. The present invention also provides a compound of formula (I) or a pharmaceutically acceptable salt, a prodrug, a composition, or an ester thereof, wherein A is a group of formulas (A), (B), (C) or (D); R.sup.1, R.sup.2, R.sup.3, R.sup.5 or R.sup.6 is H, or an optionally substituted and/or heteroatom-bearing alkyl, alkenyl, alkynyl, or cyclic group; Y and/or Z are CH.sub.2, O, S, SO, SO.sub.2, amino, amides, carbamates, ureas, or thiocarbonyl derivatives thereof, optionally substituted with an alkyl, alkenyl, or alkynyl group; n is from 1 to 5; X is a bond, an optionally substituted methylene or ethylene, an amino, O or S; Q is C(O), C(S), or SO.sub.2; m is from 0 to 6; R.sup.4 is OH, .dbd.O (keto), NH.sub.2, or alkylamino, including esters, amides, and salts thereof; and W is C(O), C(S), S(O), or SO.sub.2. Optionally, R.sup.5 and R.sup.6, together with the N--W bond of formula (I), comprises a macrocyclic ring.
Inventor(s): Erickson; John W. (Frederick, MD), Gulnik; Sergei V. (Frederick, MD), Mitsuya; Hiroaki (Chevy Chase, MD), Ghosh; Arun K. (River Forest, IL)
Assignee: The United States of America as represented by the Department of Health and Human Services (Washington, DC) N/A (Urbana, IL) Board of Trustees of the University of Illinois (
Application Number:09/720,276
Patent Claim Types:
see list of patent claims
Patent Metrics:
Source: PatentQuant.com
Field: Biotechnology
Back Citations: 39th percentile
Forward Citations: 1st percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Janssen Prods
darunavir ethanolate
TABLET;ORAL021976-004Dec 18, 2008RXNo7,470,506*PEDDec 23, 2019Y
Janssen Prods
darunavir ethanolate
TABLET;ORAL021976-005Dec 18, 2008RXNo7,470,506*PEDDec 23, 2019Y
Janssen Prods
darunavir ethanolate
TABLET;ORAL021976-001Jun 23, 2006DISCNNo7,470,506*PEDDec 23, 2019Y
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Foreign Priority and PCT Information for Patent: 7,470,506

PCT Information
PCT FiledJune 23, 1999PCT Application Number:PCT/US99/14119
PCT Publication Date:December 29, 1999PCT Publication Number: WO99/67417

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