SUSTIVA Drug Patent Profile
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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. 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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Summary for SUSTIVA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 107 |
| Clinical Trials: | 68 |
| Patent Applications: | 5,146 |
| 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 |
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 | ||||
| >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 |
| >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 |
|---|---|---|---|
| Denmark | 1067936 | ⤷ Sign Up | |
| Poland | 194309 | ⤷ Sign Up | |
| Norway | 993779 | ⤷ Sign Up | |
| Spain | 2353458 | ⤷ 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 | C300032 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528 |
| 0582455 | 91446 | Luxembourg | ⤷ Sign Up | 91446, EXPIRES: 20180803 |
| 0915894 | SPC/GB08/033 | United Kingdom | ⤷ Sign Up | 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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