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Details for Patent: 7,125,879

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Patent 7,125,879 protects EDURANT, COMPLERA, and ODEFSEY, and is included in three NDAs. There has been one Paragraph IV challenge on Complera.

This patent has one hundred and fifty patent family members in thirty-six countries.

Summary for Patent: 7,125,879

Title:HIV inhibiting pyrimidines derivatives
Abstract:This invention concerns HIV replication inhibitors of formula (I) the N-oxides, the pharmaceutically acceptable addition salts, the quaternary amines and the stereochemically isomeric forms thereof, wherein the ring containing -a.sup.1=a.sup.2-a.sup.3=a.sup.4--and -b.sup.1=b.sup.2-b.sup.3=b.sup.4represents pheynl, pyridyl, pyrimidinyl, pirazinyl, pyridazinyl; n is 0 to 5; m is 1 to 4; R.sup.1 is hydrogen; aryl; formyl; C.sub.1-6alkylcarbonyl; C.sup.1-6alkyl; C.sub.1-6alkyloxycarbonyl, substituted C.sub.1-6alkyl, C.sub.1-6alkylcarbonyl; R.sup.2 is hydroxy, halo, optionally substituted C.sub.1-6alkyl, C.sub.3-7cycloalkyl, optionally substituted C.sub.2-6alkenyl, optionally substituted C.sub.2-6alkynyl, C.sub.1-6alkyloxy, C.sub.1-6alkyloxycarbonyl, carboxyl, cyano, nitro, amino, mono- or di(C.sub.1-6alkyl)amino, polyhalomethyl, polyhalomethyloxy, polyhalomethylthio, --S(.dbd.O).sub.pR.sup.6, --NH--S(.dbd.O).sub.pR.sup.6, --C(.dbd.O)R.sup.6, --NHC(.dbd.O)H, --C(.dbd.O)NHNH?2?, --NHC(.dbd.O)R.sup.6, --C(.dbd.NH)R.sup.6 or a 5-membered hetrocycl; X.sub.1 is --NR.sup.5--, --NH--NH--, --N.dbd.N--, --O--, --C(.dbd.O)--, C.sub.1-4alkanediyl, --CHOH--, --S--, --S(.dbd.O).sub.p--, --X.sub.2--C.sub.1-4alkanediyl- or --C.sub.1-4alkanediyl-X.sub.2--; R.sup.3 is NHR.sup.13, NR.sup.13R.sup.14; --C(.dbd.O)--NHR.sup.13; --C(.dbd.O)--NR.sup.13R.sup.14; --C(.dbd.O)--R.sup.15; --CH.dbd.N--NH--C(.dbd.O)--R.sup.16; substituted C.sub.1-6alkyl; optionally substituted C.sub.1-6alkyloxyC.sub.1-6alkyl; substituted C.sub.2-6alkenyl; substituted C.sub.2-6alkynyl; substituted C.sub.2-6alkylenyl; C.sub.1-6alkyl substituted with hydroxy and a second substituent; --C(.dbd.N--O--R.sup.8)--C.sub.1-4alkyl; R.sup.7; or --X.sub.3--R.sup.7; R.sup.4 is halo, hydroxy, C.sub.1-6alkyl, C.sub.3-7cycloalkyl, C.sub.1-6alkyloxy, cyano, nitro, polyhaloC.sub.1-6alkyl, polyhaloC.sub.1-6alkyloxy, aminocarbonyl, C.sub.1-6alkyloxycarbonyl, C.sub.1-6alkylcarbonyl, formyl, amino, mono- or di(C.sub.1-4alkyl) amino; their use as a medicine, their processes for preparation and pharmaceutical compositions comprising them ##STR00001##
Inventor(s): Guillemont; Jeo (Ande, FR), Palandjian; Patrice (Louviers, FR), de Jonge; Marc Rene (Tilburg, NL), Koymans; Lucien Maria Henricus (Retie, BE), Vinkers; Hendrik Maarten (Antwerp, BE), Daeyaert; Frederik Frans Desire (Beerse, BE), Heeres; Jan (Vosselaar, BE), Van Aken; Koen Jeanne Alfons (Kortrijk, BE), Lewi; Paulus Joannes (Turnhout, BE), Arts, legal representative; Frank Xavier Josef Herwig (Beerse, BE), Janssen, deceased; Paul Adriaan Jan (Turnhout, BE)
Assignee: Janssen Pharmaceutica N.V. (Beerse, BE)
Application Number:10/485,636
Patent Claim Types:
see list of patent claims
Compound; Composition; Process; Use; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Organic fine chemistry
Back Citations: 7th percentile
Forward Citations: 4th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYes7,125,879► subscribeYY IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, IS INDICATED FOR THE TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN ANTIRETROVIRAL TREATMENT-NAIVE ADULT PATIENTS, AS SET FORTH IN THE LABELING, INCLUDING I&U SECTION
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYes7,125,879► subscribeYY IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT-NAIVE ADULT PATIENTS WITH HIV-1 RNA LESS THAN OR EQUAL TO 100,000 AT THE START OF THERAPY
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYes7,125,879► subscribeYY IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT-NAIVE PATIENTS WITH HIV-1 RNA LESS THAN OR EQUAL TO 100,000 AT THE START OF THEARPY
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Foreign Priority and PCT Information for Patent: 7,125,879

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
01203090Aug 13, 2001
02077748Jun 10, 2002
PCT Information
PCT FiledAugust 09, 2002PCT Application Number:PCT/EP02/08953
PCT Publication Date:February 27, 2003PCT Publication Number: WO03/016306

Non-Orange Book Patents for Patent: 7,125,879

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
8,841,310Combinations of a pyrimidine containing NNRTI with RT inhibitors► subscribe
7,638,522Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino] benzonitrile► subscribe
7,956,063Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile► 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 Patent: 7,125,879

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO)1610► subscribe
African Regional IP Organization (ARIPO)200402993► subscribe
African Regional IP Organization (ARIPO)200603551► 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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