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Serving leading biopharmaceutical companies globally:

Covington
UBS
Colorcon
Fish and Richardson
US Army
Moodys
Cipla
US Department of Justice
Teva
Fuji

Generated: February 24, 2018

DrugPatentWatch Database Preview

SUSTIVA Drug Profile

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When do Sustiva patents expire, and what generic alternatives are available?

Sustiva is a drug marketed by Bristol Myers Squibb and is included in two NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

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

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

US Patents and Regulatory Information for SUSTIVA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-003 Sep 17, 1998 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-002 Feb 1, 2002 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-001 Feb 1, 2002 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for SUSTIVA

Paragraph IV (Patent) Challenges for SUSTIVA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 50 mg, 100 mg and 200 mg ➤ Subscribe 11/3/2016
➤ Subscribe Tablets 600 mg ➤ Subscribe 4/9/2009

Non-Orange Book US Patents for 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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for SUSTIVA

Supplementary Protection Certificates for SUSTIVA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0915894/02 Switzerland ➤ Try a Free Trial PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
/2000 Austria ➤ Try a Free Trial 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
C/GB08/033 United Kingdom ➤ Try a Free Trial 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
C/GB00/035 United Kingdom ➤ Try a Free Trial 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
C0020 France ➤ Try a Free Trial PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
00032 Netherlands ➤ Try a Free Trial PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
01C/001 Belgium ➤ Try a Free Trial PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
08/016 Ireland ➤ Try a Free Trial PRODUCT NAME: A COMBINATION OF EFAVIRENZ AND EMTRICTABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
C0021 France ➤ Try a Free Trial PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
C/GB08/022 United Kingdom ➤ Try a Free Trial PRODUCT NAME: A COMBINATION OF EFAVIRENZ, EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF, AND TENOFOVIR OR A PHARMACEUTICALLY ACCEPTABLE PRODRUG, SALT OR ESTER THEREOF, PARTICULARLY TENOFOVIR DISOPROXIL, ESPECIALLY TENOFOVIR DISOPROXIL FUMARATE; REGISTERED: UK EU/1/07/430/001 20071213
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Dow
Chubb
Express Scripts
Baxter
QuintilesIMS
Argus Health
Merck
Colorcon
Queensland Health

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