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SUSTIVA Drug Profile

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Sustiva is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from four suppliers. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-eight patent family members in twenty-seven countries.

The generic ingredient in SUSTIVA is efavirenz. There are twenty-three drug master file entries for this compound. Four suppliers are listed for this compound. There are twenty-eight tentative approvals for this compound. Additional details are available on the efavirenz profile page.

Clinical Trials for: SUSTIVA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-001Feb 1, 2002DISCNNo6,939,964*PED<disabled>Y<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-003Sep 17, 1998RXYes6,639,071*PED<disabled>Y<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-001Sep 17, 1998RXNo6,939,964*PED<disabled>Y<disabled>
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Expired Patents for Tradename: SUSTIVA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-002Feb 1, 20025,663,169*PED<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-001Feb 1, 20025,811,423<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-002Sep 17, 19985,663,169*PED<disabled>
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Paragraph IV activity for: SUSTIVA

Drugname Dosage Strength RLD Submissiondate
efavirenzTablets600 mgSustiva4/9/2009

Non-Orange Book Patents for Tradename: SUSTIVA

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
5,965,729 Process for the crystallization of a reverse transcriptase inhibitor using an anti-solvent<disabled in preview>
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International Patent Family for Tradename: SUSTIVA

Country Document Number Estimated Expiration
China1191242<disabled in preview>
European Patent Office1067936<disabled in preview>
Austria223719<disabled in preview>
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Supplementary Protection Certificates for Tradename: SUSTIVA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB00/035United Kingdom<disabled>PRODUCT NAME: EFAVIRENZ, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH IKS-54 908 01 19981120; CH IKS-54 908 02 19981120; CH IKS-54 908 03 19981120; UK EU/1/99/110/001 19990528; UK EU/1/99/110/002 19990528; UK EU/1/99/110/003 19990528; UK EU/1/99/110/004 19990528; UK EU/1/99/111/001 19990528; UK EU/1/99/111/002 19990528; UK EU/1/99/111/003 19990528; UK EU/1/99/111/004 19990528
C/GB08/033United Kingdom<disabled>PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
/2000Austria<disabled>PRODUCT NAME: EFAVIRENZ, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/99/110/001-004 1/99/111/001-004 19990528; FIRST REGISTRATION: LI 54908 01, 54908 02, 54908 03 19981120
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