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Last Updated: November 21, 2024

SUSTIVA Drug Patent Profile


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When do Sustiva patents expire, and when can generic versions of Sustiva launch?

Sustiva is a drug marketed by Bristol Myers Squibb and is included in two NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Sustiva

A generic version of SUSTIVA was approved as efavirenz by AUROBINDO PHARMA on December 15th, 2017.

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Drug patent expirations by year for SUSTIVA
Drug Prices for SUSTIVA

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Recent Clinical Trials for SUSTIVA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Case Western Reserve UniversityPhase 1
University Hospitals Cleveland Medical CenterPhase 1
Massachusetts General HospitalPhase 1

See all SUSTIVA clinical trials

Paragraph IV (Patent) Challenges for SUSTIVA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUSTIVA Capsules efavirenz 50 mg, 100 mg and 200 mg 020972 1 2016-11-03
SUSTIVA Tablets efavirenz 600 mg 021360 1 2009-04-09

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 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-001 Feb 1, 2002 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-003 Sep 17, 1998 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-002 Feb 1, 2002 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SUSTIVA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-003 Sep 17, 1998 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-001 Feb 1, 2002 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-003 Sep 17, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for SUSTIVA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Teva B.V. Efavirenz Teva efavirenz EMEA/H/C/002352
Efavirenz is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children 3 years of age and older.Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with protease inhibitors (PIs) has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing efavirenz.
Authorised yes no no 2012-01-09
Merck Sharp & Dohme B.V. Stocrin efavirenz EMEA/H/C/000250
Stocrin is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older.Stocrin has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Stocrin.
Authorised no no no 1999-05-28
Bristol-Myers Squibb Pharma EEIG Sustiva efavirenz EMEA/H/C/000249
Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older.Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Sustiva.
Authorised no no no 1999-05-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for SUSTIVA

See the table below for patents covering SUSTIVA around the world.

Country Patent Number Title Estimated Expiration
Canada 2279198 PROCEDE DE CRISTALLISATION D'UN INHIBITEUR DE TRANSCRIPTASE INVERSE UTILISANT UN ANTISOLVANT (PROCESS FOR THE CRYSTALLIZATION OF A REVERSE TRANSCRIPTASE INHIBITOR USING AN ANTI-SOLVENT) ⤷  Sign Up
Eurasian Patent Organization 003217 ПОЛУЧЕНИЕ КАПСУЛ И ТАБЛЕТОК БЫСТРОРАСТВОРЯЮЩЕГОСЯ ЭФАВИРЕНЗА С ИСПОЛЬЗОВАНИЕМ СУПЕРДЕЗИНТЕГРАТОРОВ (FORMULATION OF FAST-DISSOLVING EFAVIRENZ CAPSULES OR TABLETS USING SUPER-DESINTEGRANTS) ⤷  Sign Up
Australia 756422 ⤷  Sign Up
Canada 2321523 PROCEDE UTILISANT DES SUPER-DESINTEGRANTS DANS LA PREPARATION DE CAPSULES OU DE COMPRIMES D'EFAVIRENZ A DISSOLUTION RAPIDE (FORMULATION OF FAST-DISSOLVING EFAVIRENZ CAPSULES OR TABLETS USING SUPER-DISINTEGRANTS) ⤷  Sign Up
Eurasian Patent Organization 200001030 ⤷  Sign Up
China 1090277 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SUSTIVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0582455 40/2000 Austria ⤷  Sign Up 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
0582455 2001C/001 Belgium ⤷  Sign Up PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
0582455 SPC/GB00/035 United Kingdom ⤷  Sign Up 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
0582455 2008/016 Ireland ⤷  Sign Up PRODUCT NAME: A COMBINATION OF EFAVIRENZ AND EMTRICTABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0582455 SPC029/2000 Ireland ⤷  Sign Up SPC029/2000: 20050912, EXPIRES: 20131119
0582455 CA 2008 00026 Denmark ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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