SUSTIVA Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Sustiva, and what generic alternatives are available?
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. Nine 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.
Summary for SUSTIVA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 107 |
Clinical Trials: | 68 |
Patent Applications: | 5,414 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SUSTIVA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SUSTIVA |
What excipients (inactive ingredients) are in SUSTIVA? | SUSTIVA excipients list |
DailyMed Link: | SUSTIVA at DailyMed |
Recent Clinical Trials for SUSTIVA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Hospitals Cleveland Medical Center | Phase 1 |
Massachusetts General Hospital | Phase 1 |
Case Western Reserve University | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for SUSTIVA
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bristol Myers Squibb | SUSTIVA | efavirenz | TABLET;ORAL | 021360-001 | Feb 1, 2002 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-002 | Sep 17, 1998 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 | 020972-002 | Sep 17, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-001 | Sep 17, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Bristol Myers Squibb | SUSTIVA | efavirenz | TABLET;ORAL | 021360-002 | Feb 1, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Spain | 2151897 | ⤷ Try a Trial | |
Eurasian Patent Organization | 003217 | ПОЛУЧЕНИЕ КАПСУЛ И ТАБЛЕТОК БЫСТРОРАСТВОРЯЮЩЕГОСЯ ЭФАВИРЕНЗА С ИСПОЛЬЗОВАНИЕМ СУПЕРДЕЗИНТЕГРАТОРОВ (FORMULATION OF FAST-DISSOLVING EFAVIRENZ CAPSULES OR TABLETS USING SUPER-DESINTEGRANTS) | ⤷ Try a Trial |
Japan | 2017061575 | 逆溶媒を使用する逆転写酵素阻害剤の結晶化方法 (PROCESS FOR THE CRYSTALLIZATION OF REVERSE TRANSCRIPTASE INHIBITOR USING ANTI-SOLVENT) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SUSTIVA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0582455 | C300032 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528 |
0582455 | SPC/GB08/022 | United Kingdom | ⤷ Try a 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 |
0915894 | C00915894/02 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |