Efavirenz

Sold as Sustiva, Efavirenz 200mg Scored Tablets, Efavirenz. Every FDA application for this active ingredient: 5 branded and 18 generic.

As of Nov 15, 2026, FDA lists 23 applications for Efavirenz (sold as Sustiva, Efavirenz 200mg Scored Tablets, Efavirenz), first approved Sep 17, 1998, with 5 new uses approved and 0 published complete response letters.

First approved: Sep 17, 1998
Applications: 23
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $3.2M
First approved in the EU: May 28, 1999

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Efavirenz	Part D	$3.2M	-25%	1,376

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

EFAVIRENZ 600 MG TABLET: $1.19 per unitGeneric · -32% in a year

Approvals in the EU (EMA)

First approved in the EU 8 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Efavirenz Teva, genericTeva B.V. · Jan 9, 2012
Stocrin, new substanceMerck Sharp & Dohme B.V. · May 28, 1999 · withdrawn
SustivaBristol-Myers Squibb Pharma EEIG · May 28, 1999 · withdrawn

Clinical Trials

13 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Comparative Trial Between Ainuovirine(ANV)/Lamivudine(3TC)/Tenofovir(TDF) and Efavirenz(EFV)/Lamivudine/Tenofovir RegimensHIV, Art Therapy · Shanghai Public Health Clinical Center	Phase 4	Not yet recruiting	Jun 8, 2026
Drug-Drug Interactions of JMKX003142 in Healthy ParticipantsADPKD (Autosomal Dominant Polycystic Kidney Disease) · Jemincare	Phase 1	Not yet recruiting	May 4, 2026
Efavirenz for the Treatment of Creutzfeldt-Jakob DiseaseCreutzfeldt-Jakob Disease · Xuanwu Hospital, Beijing	Phase 3	Recruiting	Mar 19, 2026
A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itraconazole, Fluconazole or Efavirenz on a Single Dose of Clifutinib in Healthy ParticipantsHealthy Adult Subject · Sunshine Lake Pharma Co., Ltd.	Phase 1	Not yet recruiting	Jan 14, 2026
Research on the Psychological Status of Patients With HIV-1 InfectionHIV-1-infection, Anxiety Depression · Shanxi Bethune Hospital	—	Not yet recruiting	Jul 23, 2025
The T Cell Activator of Cell Killing ("TACK") IT ON" STUDYHiv · University of Toronto	Not applicable	Recruiting	Feb 12, 2025
Study Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV VirusesHIV Infections, HBV Coinfection · ANRS, Emerging Infectious Diseases	Phase 2	Not yet recruiting	Apr 1, 2024
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV TreatmentsHIV-1-infection · Gilead Sciences	Phase 4	Recruiting	Mar 29, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 17, 1998	SustivaNDA 20972 · New molecular entity	Bristol Myers Squibb	45	Discontinued
Feb 1, 2002	SustivaNDA 21360 · New dosage form	Bristol Myers Squibb	33	Discontinued
Feb 17, 2016	EfavirenzANDA 91471	Mylan	3	Discontinued
Dec 15, 2017	EfavirenzANDA 78064	Aurobindo Pharma	2	Marketed
Mar 12, 2018	EfavirenzANDA 204869	Pharmobedient	2	Discontinued
Apr 27, 2018	EfavirenzANDA 78886	Hetero Labs Ltd Iii	2	Marketed
Jun 15, 2018	EfavirenzANDA 204766	Cipla	2	Marketed
Aug 30, 2018	EfavirenzANDA 205322	Aurobindo Pharma	0	Discontinued
Sep 21, 2018	EfavirenzANDA 77673	Aurobindo Pharma Ltd	2	Marketed
Jun 16, 2021	EfavirenzANDA 78509	Strides Pharma	1	Discontinued
May 10, 2024	EfavirenzANDA 91579	Macleods Pharms	0	Marketed
—	EfavirenzANDA 77916	Cipla Limited	0	Discontinued
—	EfavirenzANDA 78883	Matrix Labs	0	Discontinued
—	EfavirenzANDA 78958	Emcure Pharma	0	Discontinued
—	EfavirenzANDA 90155	Cipla Limited	0	Discontinued
—	EfavirenzANDA 91175	Teva Pharms USA	0	Discontinued
—	EfavirenzANDA 202042	Micro Labs Ltd	0	Discontinued
—	EfavirenzANDA 202301	Micro Labs Ltd	0	Discontinued
—	EfavirenzANDA 202990	Par Formulations Private Ltd	0	Discontinued
—	EfavirenzANDA 207895	Pharmacare Ltd	0	Discontinued
—	Efavirenz 200mg Scored TabletsNDA 22420	Strides Arcolab Ltd	0	Discontinued
—	EfavirenzNDA 22461	Matrix Labs Ltd	0	Discontinued
—	EfavirenzNDA 205389	Micro Labs Ltd India	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA