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:	5,583
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
University Hospitals Cleveland Medical Center	Phase 1
Massachusetts General Hospital	Phase 1
Case Western Reserve University	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	TABLET;ORAL	021360-001	Feb 1, 2002	5,663,169*PED
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-002	Sep 17, 1998	5,811,423
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-003	Sep 17, 1998	5,811,423
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002	5,519,021*PED
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002	5,811,423
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-002	Sep 17, 1998	6,939,964*PED
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-001	Sep 17, 1998	6,555,133*PED

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
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
Poland	307348
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)
Portugal	1067936
Eurasian Patent Organization	003217	ПОЛУЧЕНИЕ КАПСУЛ И ТАБЛЕТОК БЫСТРОРАСТВОРЯЮЩЕГОСЯ ЭФАВИРЕНЗА С ИСПОЛЬЗОВАНИЕМ СУПЕРДЕЗИНТЕГРАТОРОВ (FORMULATION OF FAST-DISSOLVING EFAVIRENZ CAPSULES OR TABLETS USING SUPER-DESINTEGRANTS)
China	1250652
Poland	175615

Supplementary Protection Certificates for SUSTIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0582455	C300032	Netherlands		PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
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	CA 2001 00014	Denmark
0582455	40/2000	Austria		PRODUCT NAME: EFAVIRENZ, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/99/110/001-004 1/99/111/001-004 19990528; FIRST REGISTRATION: LI 54908 01, 54908 02, 54908 03 19981120
0915894	C00915894/02	Switzerland		PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
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

Market Dynamics and Financial Trajectory for SUSTIVA

Last updated: July 27, 2025

Introduction

Sustiva (efavirenz) is a landmark antiretroviral drug primarily used in the treatment of HIV-1 infection. Since its launch, Sustiva has established a significant presence in the global HIV therapeutics market, driven by its efficacy, regulatory approvals, and formulation advantages. This analysis explores the evolving market dynamics that influence Sustiva’s trajectory, including competitive landscape, regulatory factors, pricing strategies, and emergent trends shaping its financial future.

Historical Context and Product Profile

Launched in the early 2000s by Bristol-Myers Squibb (later acquired by Bristol-Myers Squibb and subsequently by other stakeholders), Sustiva was among the first non-nucleoside reverse transcriptase inhibitors (NNRTIs) to achieve widespread use. Its once-daily dosing, proven efficacy, and established safety profile made it a cornerstone in antiretroviral therapy (ART) regimens for years. Its inclusion in fixed-dose combination pills contributed to its broad adoption across diverse patient populations [1].

Market Dynamics

Global HIV Epidemic and Therapy Adoption

The rising global HIV burden continues to sustain sustained demand for effective antiretroviral agents. According to UNAIDS, approximately 38 million people globally were living with HIV in 2021, with increasing access to ART therapy in low- and middle-income countries (LMICs) broadening the market base [2]. Sustiva, historically positioned as a first-line therapy, benefits from this expanded demand, especially where generic versions are not yet widespread.

Generic Penetration and Patent Expiry

The patent for Sustiva expired in key jurisdictions—including the U.S. and EU—around 2018–2020. This patent expiration led to the entry of generic efavirenz products by multiple manufacturers, exerting downward pressure on Sustiva’s pricing and sales volumes [3]. Generic competition has made cost-effective treatment options accessible, especially in LMICs, but has also shifted the market away from branded Sustiva in favor of lower-priced alternatives.

Therapeutic Shift Towards Integrative Regimens

Recent clinical guidelines emphasize integrase strand transfer inhibitors (INSTIs) like dolutegravir as preferred first-line agents due to superior tolerability and resistance profiles [4]. This shift diminishes Sustiva’s market share among new patients, although it retains a role in certain treatment protocols and patient populations resistant to newer agents.

Safety and Tolerability Profile

Despite its efficacy, Sustiva’s neuropsychiatric side effects—such as vivid dreams and mood disturbances—have limited its appeal, particularly in developed countries. This nuance influences prescriber preferences and impacts future sales trajectories.

Regulatory and Market Access Factors

Regulatory agencies continue to approve Sustiva for use based on existing data, but the drug's positioning is increasingly impacted by non-inferiority of generic options and newer agents. Pricing and reimbursement policies, particularly in LMICs supported by Gilead’s prior global health initiatives, influence the accessibility and financial sustainability of Sustiva.

Financial Trajectory Analysis

Revenue Trends Post-Patent Expiry

Bristol-Myers Squibb historically reported Sustiva revenues topping several hundred million dollars annually. Following patent expiry and the advent of generics, sales declined markedly in developed markets, a pattern consistent with the typical lifecycle of branded HIV drugs.

Generic Market Impact

The proliferation of generic efavirenz significantly curbed Sustiva’s profitability. According to IQVIA data, generic efavirenz accounted for over 80% of efavirenz prescriptions in several markets as of 2021 [5]. This commoditization drives down the average sales price (ASP), constraining revenue growth for the original branded manufacturer.

Emerging Revenue Streams

Despite declining traditional sales, existing formulations continue to generate revenue through:

• Lifelong Therapy Revenue: Chronic HIV management ensures ongoing demand.
• Fixed-Dose Combinations (FDCs): Sustiva’s inclusion in combination pills by different manufacturers sustains revenue streams indirectly.
• Regional Partnerships: In LMICs, licensing agreements and supply contracts maintain sales levels owing to strategic partnerships.

Strategic Response and Pipeline Outlook

The manufacturer’s strategic pivot involves focusing on newer formulations, such as integrase inhibitors with improved tolerability or developing sustained-release formulations of efavirenz to enhance adherence and patient compliance. Investment in these pipeline candidates influences future revenue projections, with potential to offset patent-related declines [6].

Market Valuation and Investment Implications

Financial forecasts suggest Sustiva’s standalone revenues will continue to decline over the next 5-7 years in high-income markets due to generic competition, but emerging markets may present stable or modest growth opportunities driven by preferential access and strategic partnerships. The overall market valuation of Sustiva for pharmaceutical investors hinges on the successful commercialization of next-generation products and pipeline assets.

Competitive Landscape

Key competitors include generic efavirenz producers and newer agents. Despite its historical dominance, Sustiva now faces challenges from drugs like dolutegravir (Tivicay), bictegravir (Biktarvy), and doravirine (Pifeltro). These competitors offer enhanced tolerability, fewer drug interactions, and simplified dosing, further threatening Sustiva’s market share in therapeutic niches [7].

Regulatory Trends and Future Outlook

Regulatory agencies are now emphasizing bioequivalence studies and quality standards for generic counterparts, which promote broader access but erode the premium pricing that Sustiva once commanded. Future regulatory hurdles include potential resistance from stakeholders wishing to protect innovation but are balanced by global health initiatives advocating accessible HIV treatment.

Key Drivers for Sustiva’s Financial Trajectory:

1. Patent Status: Its expiration set the stage for volume reductions in developed markets but opened opportunities in less mature markets.
2. Competitive Dynamics: The rise of INSTI-based regimens diminishes Sustiva’s uptake among new patients.
3. Cost-Effectiveness: Generics’ affordability in LMICs sustains demand despite declining brand sales.
4. Pipeline Development: New formulations and combination therapies could extend lifecycle value.
5. Healthcare Policy: Evolving guidelines favor newer agents, impacting sustained demand for efavirenz-based therapies.

Conclusion

Sustiva’s market position is transitioning from dominance in the early 2000s to a niche or supplemental role amid evolving HIV treatment paradigms. While patent expiry and generic competition have compressed revenues significantly, sustained demand persists due to global HIV burden and existing treatment infrastructures. Future financial trajectories depend heavily on strategic pipeline development, regional market dynamics, and shifting treatment guidelines favoring newer agents. Investment and operational strategies that leverage emerging formulations and expand access in underserved regions will determine Sustiva’s long-term financial relevance.

Key Takeaways

• Patent expiry and generic competition have substantially diminished Sustiva's revenue, particularly in high-income markets.
• Global HIV prevalence ensures ongoing, albeit declining, demand for efavirenz-based therapies.
• Preference shift towards INSTI-based regimens reduces Sustiva’s attractiveness among new patients.
• Emerging pipeline solutions, such as sustained-release formulations, could prolong commercial viability.
• Market access strategies in LMICs remain pivotal, where generics dominate and Sustiva continues to contribute to HIV treatment.

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FAQs

1. What factors contributed to Sustainva’s initial market dominance?
   Its once-daily dosing, proven efficacy, safety profile, and inclusion in combination therapies fueled its widespread adoption during early years of HIV treatment.

2. How has patent expiration affected Sustiva’s profitability?
   Patent expiry facilitated the entry of generic competitors, driving down prices and sales volumes, reducing overall profitability for the original manufacturer.

3. What are the primary reasons for the decline in Sustiva’s market share?
   Safety concerns related to neuropsychiatric side effects and the emergence of newer, better-tolerated drugs like dolutegravir led prescribers to favor alternative agents.

4. Can Sustiva’s role in HIV treatment be revived?
   While unlikely as a first-line agent due to newer therapies, sustained-release formulations and combination products may preserve its relevance in specific niches.

5. What strategies can manufacturers adopt to extend Sustiva’s commercial lifespan?
   Developing improved formulations, expanding into underserved markets, and leveraging patent protections for novel delivery systems are key strategies.

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References

[1]UNAIDS. Global HIV & AIDS statistics — 2021 factsheet.
[2]UNAIDS. Global HIV Epidemiology — 2022 Report.
[3]FDA. Efavirenz Powder for Suspension & Tablets—Patent Status.
[4]WHO. Guidelines on HIV Treatment — 2022 Update.
[5]IQVIA. Global HIV Market Data — 2021.
[6]Pharmaceutical Pipeline Database. Emerging formulations of Efavirenz.
[7]Clinical Pharmacology. Comparative efficacy of NNRTIs and INSTIs.