SUSTIVA Drug Patent Profile

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 15^th, 2017.

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

See drug prices for SUSTIVA

Recent Clinical Trials for SUSTIVA

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

Sponsor	Phase
Case Western Reserve University	Phase 1
University Hospitals Cleveland Medical Center	Phase 1
Massachusetts General Hospital	Phase 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
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002		DISCN	Yes	No
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-002	Sep 17, 1998		DISCN	Yes	No
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-003	Sep 17, 1998		DISCN	Yes	No
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-002	Feb 1, 2002		DISCN	Yes	No

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
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-003	Sep 17, 1998
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-003	Sep 17, 1998
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-001	Sep 17, 1998
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-002	Sep 17, 1998

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

International Patents for SUSTIVA

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2186775	BENZOXAZINONES AND PHARMACEUTICAL COMPOSITION COMPRISING THEREOF FOR INHIBITION OF ACTIVITY OF HIV REVERSE TRANSCRIPTASE, TREATMENT AND PROPHYLAXIS OF AIDS AND ARS, METHOD OF INHIBITION OF ACTIVITY OF HIV REVERSE TRANSCRIPTASE, METHOD OF PROPHYLAXIS OF HIV INFECTION, TREATMENT OF HIV AND ARS, COMBINATIONS, METHOD OF SYNTHESIS OF (-)-6-CHLORO- -4-CYCLOPROPYLETHYNYL-4-TRIFLUOROMETHYL-1,4- -DIHYDRO-2H-3,1-BENZOXAZINE-2-ONE
Romania	113641	DERIVATI DE BENZOXAZINONA, PROCEDEU DE PREPARARE A ACESTORA, COMPOZITII SI COMBINATII FARMACEUTICE SI METODA DE INHIBARE A HIV REVERSTRANSCRIPTAZEI (BENZOXAZINONE DERIVATIVES, PROCESS FOR PREPARING SUCH DERIVATIVES, PHARMACEUTICAL COMPOSITIONS AND COMBINATIONS, AND METHOD FOR INHIBITING OF HIV REVERSE TRANSCRIPTASE)
Poland	334478
Germany	69841972
Hungary	0001313
United Kingdom	9709348

Supplementary Protection Certificates for SUSTIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0915894	C00915894/02	Switzerland		PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
0582455	CA 2001 00014	Denmark
0582455	2008/016	Ireland		PRODUCT NAME: A COMBINATION OF EFAVIRENZ AND EMTRICTABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0582455	2001C/001	Belgium		PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
0582455	SPC/GB08/022	United Kingdom		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
0582455	91446	Luxembourg		91446, EXPIRES: 20180803