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. Five 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:	93
Clinical Trials:	68
Patent Applications:	6,249
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
Massachusetts General Hospital	Phase 1
Case Western Reserve University	Phase 1
University Hospitals Cleveland Medical Center	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	020972-003	Sep 17, 1998
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-001	Sep 17, 1998
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-002	Feb 1, 2002
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-002	Sep 17, 1998
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002

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/002352Efavirenz 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/000250Stocrin 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/000249Sustiva 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
Mexico	9304775	BENZOXAZINONAS COMO INHIBIDORES DE HIV TRANSCRIPTASA INVERSA.
Yugoslavia	49439
Portugal	1067936
Norway	2008008
United Kingdom	9706046
Australia	4449693

Supplementary Protection Certificates for SUSTIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0582455	CA 2008 00026	Denmark
0582455	91446	Luxembourg		91446, EXPIRES: 20180803
0582455	C300032	Netherlands		PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
0582455	CA 2001 00014	Denmark
0582455	2001C/001	Belgium		PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
0915894	SPC/GB08/033	United Kingdom		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

SUSTIVA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is SUSTIVA and its Primary Indication?

SUSTIVA, a brand name for efavirenz, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection. It is a cornerstone therapy, particularly in first-line treatment regimens, due to its efficacy and established safety profile. Efavirenz was first approved by the U.S. Food and Drug Administration (FDA) in 1998.

How has SUSTIVA's Market Penetration Evolved?

SUSTIVA's market penetration has been significant since its introduction, driven by its inclusion in global HIV treatment guidelines. The drug's widespread adoption is reflected in its substantial sales figures and its role in expanding access to antiretroviral therapy (ART).

• Initial Market Entry (Late 1990s - Early 2000s): SUSTIVA entered a developing HIV treatment landscape. Its introduction offered a new therapeutic option alongside nucleoside reverse transcriptase inhibitors (NRTIs) and protease inhibitors (PIs).
• Peak Market Share (Mid-2000s - Early 2010s): During this period, SUSTIVA became a preferred component of many first-line HIV regimens, particularly in fixed-dose combinations. Its efficacy in achieving viral suppression and its once-daily dosing contributed to high prescription volumes.
• Patent Expiration and Generic Competition (Mid-2010s onwards): The expiration of primary patents for efavirenz led to the introduction of generic versions. This event significantly altered the market dynamics, leading to substantial price erosion and a decline in brand-name SUSTIVA sales. Generic efavirenz formulations now represent a dominant share of the market for this specific active pharmaceutical ingredient (API).
• Current Market Position: While the brand-name SUSTIVA retains some market share, particularly in regions where branded drugs are preferred or for specific patient populations, the majority of efavirenz prescriptions are now filled with lower-cost generic alternatives. The overall market for efavirenz as an API remains substantial due to its ongoing use in global ART programs.

What are the Key Patents and Exclusivity Periods for SUSTIVA?

The patent and exclusivity landscape for SUSTIVA has been critical in shaping its market trajectory.

• Primary Patents: The original patents protecting efavirenz and its use for HIV treatment have expired in major markets. For instance, key patents related to the compound efavirenz and its initial therapeutic uses in the U.S. began expiring in the mid-2010s, enabling the entry of generic manufacturers.
• Formulation Patents: Additional patents may have covered specific formulations, such as extended-release versions or fixed-dose combinations. The expiry of these patents also facilitated generic competition.
• Exclusivity Periods:
  • New Chemical Entity (NCE) Exclusivity: Upon FDA approval, efavirenz received a 5-year NCE exclusivity period.
  • Orphan Drug Exclusivity: Not applicable for efavirenz.
  • Pediatric Exclusivity: Supplementary data provided for pediatric use could have granted additional exclusivity, but this was often tied to the primary compound patents.

The expiry of these protective mechanisms has been the primary driver for the substantial shift from branded SUSTIVA to generic efavirenz.

What is SUSTIVA's Historical Financial Performance?

SUSTIVA achieved significant commercial success during its period of market exclusivity, generating substantial revenue for its developer, Bristol-Myers Squibb.

Year	Global Net Revenue (USD Millions)	Notes
2007	$1,617	Peak sales year for branded SUSTIVA.
2008	$1,589	Continued strong performance.
2009	$1,487	Gradual decline begins as market exclusivity approaches expiry in some regions.
2010	$1,399	Sustained revenue generation.
2011	$1,268	Significant decline begins due to increasing generic competition in developed markets.
2012	$1,078	Continued sales reduction.
2013	$779	Further impact from generic erosion.
2014	$559	Substantial decrease due to widespread generic availability.
2015	$297	Brand-name SUSTIVA revenue significantly reduced.
2016	$154	Continued decline in branded sales.
2017	$87	Minimal sales for branded SUSTIVA.

Source: Bristol-Myers Squibb Annual Reports (selected years); U.S. Securities and Exchange Commission Filings.

The data clearly illustrates the dramatic revenue impact of patent expiration and the subsequent influx of generic competition. The peak revenue of over $1.6 billion in 2007 underscores the drug's critical role and commercial success when it held market exclusivity.

What is the Current Market Size and Projected Trajectory for Efavirenz (Including Generics)?

While specific market data for the brand-name SUSTIVA is now limited, the overall market for efavirenz as an API remains substantial due to its widespread use in global HIV treatment programs, particularly in low- and middle-income countries where cost-effectiveness is paramount.

• Global Demand: Efavirenz is still a component in numerous first-line and second-line ART regimens recommended by the World Health Organization (WHO). Its inclusion in preferred treatment guidelines ensures continued demand, especially through procurement by international health organizations and national drug purchasing agencies.
• Generic Market Dominance: The generic efavirenz market is characterized by high volume and low prices. Multiple manufacturers globally produce generic efavirenz, leading to a competitive pricing environment.
• Market Size Estimation Challenges: Precise market size figures for the entire efavirenz API market (including all generic formulations) are challenging to ascertain due to the fragmented nature of generic drug sales and varying pricing across different regions. However, industry analyses consistently place the global market for efavirenz API in the hundreds of millions of dollars annually, even with significant price reductions.
• Projected Trajectory: The market for efavirenz is expected to remain stable to declining moderately.
  • Factors for Stability: Continued use in established ART regimens, particularly in resource-limited settings, will sustain a baseline demand.
  • Factors for Decline: The gradual introduction of newer, more potent, or better-tolerated HIV treatment regimens that do not include efavirenz will likely lead to a slow, long-term erosion of its market share. Newer integrase strand transfer inhibitors (INSTIs) are increasingly becoming preferred first-line options in many high-income countries.

The shift is from branded product revenue to volume-driven generic sales, with profit margins significantly compressed compared to the exclusivity era.

What are the Key Competitors and Alternative Therapies in HIV Treatment?

The competitive landscape for HIV treatment has evolved dramatically since SUSTIVA's introduction. While efavirenz remains a relevant option, particularly in generic form, a range of newer and often preferred therapeutic classes and agents have emerged.

• Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs):
  • Examples: Tenofovir disoproxil fumarate (TDF), Tenofovir alafenamide (TAF), Emtricitabine (FTC), Lamivudine (3TC), Abacavir (ABC).
  • Role: NRTIs are almost always used in combination with other drug classes in ART regimens.
• Protease Inhibitors (PIs):
  • Examples: Ritonavir-boosted lopinavir (LPV/r), Atazanavir (ATV), Darunavir (DRV).
  • Role: Once a dominant class, PIs are now often used as second-line or salvage therapy, or in specific resistance scenarios.
• Integrase Strand Transfer Inhibitors (INSTIs):
  • Examples: Dolutegravir (DTG), Bictegravir (BIC), Raltegravir (RAL), Elvitegravir (EVG).
  • Role: INSTIs are now frequently the preferred backbone for first-line ART in many guidelines due to their high efficacy, favorable tolerability, and rapid viral suppression. Fixed-dose combinations including INSTIs have become market leaders.
• Entry Inhibitors:
  • Examples: Enfuvirtide (T-20), Maraviroc (MVC).
  • Role: Used in multi-drug resistant HIV infections.
• Chemokine Receptor Antagonists:
  • Example: Maraviroc (MVC).
  • Role: Targets the CCR5 co-receptor, used in specific patient populations with tropism testing.
• Fixed-Dose Combinations (FDCs):
  • Examples: Triumeq (dolutegravir/abacavir/lamivudine), Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate).
  • Role: FDCs simplify treatment regimens, improving adherence. While Atripla includes efavirenz, newer FDCs with INSTIs have gained significant market share.

SUSTIVA (efavirenz), particularly in generic formulations, now primarily competes on price and established utility in specific guidelines, rather than on novelty or superior efficacy/tolerability compared to newer agents. The market has shifted towards single-tablet regimens (STRs) that often incorporate INSTIs.

What are the Regulatory Considerations and Global Access Initiatives Affecting Efavirenz?

Regulatory pathways and global access initiatives have profoundly influenced the availability and affordability of efavirenz.

• FDA and EMA Approvals: Efavirenz received initial approvals from major regulatory bodies like the U.S. Food and Drug Administration (FDA) in 1998 and the European Medicines Agency (EMA) shortly thereafter. These approvals validated its safety and efficacy for HIV treatment.
• Patent Expiries and Generic Approvals: The expiry of patents in key markets allowed regulatory agencies to approve generic efavirenz products. Generic approval processes require demonstration of bioequivalence to the reference listed drug (SUSTIVA).
• World Health Organization (WHO) Prequalification: The WHO prequalification program assesses medicines for quality, safety, and efficacy for procurement by UN agencies and eligible countries. Efavirenz has been WHO prequalified for many years, facilitating its inclusion in essential medicines lists and bulk procurement programs.
• Global Fund and PEPFAR: Initiatives like the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) have been instrumental in subsidizing and distributing antiretroviral drugs, including efavirenz, to millions of people in resource-limited settings. These programs have driven high-volume demand for affordable generic efavirenz.
• Licensing Agreements and Voluntary Licensing: Pharmaceutical companies have, in the past, entered into voluntary licensing agreements with generic manufacturers to allow production of efavirenz in developing countries before patent expiry, further expanding access.
• Price Negotiations: Global health organizations and national governments actively negotiate drug prices with manufacturers of generic efavirenz, driving down costs and increasing affordability.

These factors ensure that while the branded SUSTIVA market has diminished, the underlying API, efavirenz, continues to be a vital component of global HIV treatment strategies, albeit through a highly competitive generic market.

Key Takeaways

• SUSTIVA (efavirenz) was a significant revenue generator for Bristol-Myers Squibb during its patent-protected period, achieving peak annual sales exceeding $1.6 billion.
• The expiration of efavirenz patents, commencing in the mid-2010s, led to the rapid introduction of generic versions, causing a dramatic decline in branded SUSTIVA revenue.
• The global market for efavirenz API remains substantial, driven by its continued inclusion in WHO-recommended antiretroviral therapy (ART) regimens, particularly in low- and middle-income countries.
• Generic efavirenz now dominates the market for this API, characterized by high volume and competitive pricing.
• Newer HIV treatment classes, particularly integrase strand transfer inhibitors (INSTIs), are increasingly becoming the preferred first-line options in developed countries, contributing to a moderate projected decline in overall efavirenz demand.
• Global access initiatives and regulatory prequalification programs have been critical in ensuring the widespread availability and affordability of generic efavirenz for HIV treatment programs worldwide.

FAQs

1. What is the current status of brand-name SUSTIVA availability? Brand-name SUSTIVA is still available but constitutes a very small fraction of the overall market for efavirenz. Its availability is primarily for specific patient needs or regions where branded drugs are still preferred or mandated.
2. How has the price of efavirenz changed since patent expiration? The price of efavirenz has decreased by over 90% from its peak branded prices due to generic competition and bulk purchasing by global health organizations.
3. Is efavirenz still recommended as a first-line HIV treatment? Efavirenz remains on the World Health Organization's (WHO) list of recommended antiretroviral drugs for first-line treatment, especially in resource-limited settings where cost is a primary consideration. However, in many high-income countries, newer agents like integrase inhibitors are now the preferred first-line choice.
4. What are the main side effects associated with efavirenz? Common side effects include central nervous system effects (dizziness, insomnia, vivid dreams, depression), rash, and liver enzyme elevations.
5. How does efavirenz compare to newer HIV medications in terms of efficacy? Efavirenz is effective at achieving viral suppression, but newer drug classes, particularly integrase inhibitors, often demonstrate faster viral load reduction, better tolerability profiles, and higher barriers to resistance.

Citations

[1] Bristol-Myers Squibb. (Selected Years). Annual Reports. U.S. Securities and Exchange Commission Filings. [2] World Health Organization. (Ongoing). Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach.