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:	4,836
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	TABLET;ORAL	021360-002	Feb 1, 2002
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-001	Sep 17, 1998
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-003	Sep 17, 1998
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	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

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
Austria	197295
Australia	1694295
Australia	4449693
Australia	670300
Bulgaria	62612
Bulgaria	99383

Supplementary Protection Certificates for SUSTIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0582455	CA 2001 00014	Denmark
0582455	SPC029/2000	Ireland		SPC029/2000: 20050912, EXPIRES: 20131119
0582455	CA 2008 00026	Denmark
0582455	91446	Luxembourg		91446, EXPIRES: 20180803
0582455	08C0021	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0582455	SPC/GB00/035	United Kingdom		PRODUCT NAME: EFAVIRENZ, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH IKS-54 908 01 19981120; CH IKS-54 908 02 19981120; CH IKS-54 908 03 19981120; UK EU/1/99/110/001 19990528; UK EU/1/99/110/002 19990528; UK EU/1/99/110/003 19990528; UK EU/1/99/110/004 19990528; UK EU/1/99/111/001 19990528; UK EU/1/99/111/002 19990528; UK EU/1/99/111/003 19990528; UK EU/1/99/111/004 19990528

Last updated: July 29, 2026

SUSTIVA (efavirenz) Market Dynamics and Financial Trajectory: Sales Drivers, Patent/Exclusivity Timing, and Generic/Biosimilar Risk

SUSTIVA (efavirenz) is an older, first-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) in HIV treatment. The drug’s financial trajectory is dominated by (1) substitution by newer antiretroviral regimens with better tolerability and simplified dosing, (2) continued erosion from generic entry in multiple markets, and (3) ongoing demand anchored in legacy patients and fixed-dose combinations (FDCs) that still include efavirenz in certain geographies and programs. SUSTIVA’s current market dynamics are primarily volume-led in institutional procurement channels rather than protected brand growth.

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How has SUSTIVA (efavirenz) sales trended since launch?

Short answer: SUSTIVA’s sales peaked in the mid-to-late 2000s and then declined as antiretroviral standard-of-care shifted toward integrase strand transfer inhibitor (INSTI)-based regimens and newer NNRTIs. Brand exposure narrowed as generics gained share across the US and globally.

Observed drivers of decline

• Regimen evolution: INSTI-based single-tablet regimens displaced many efavirenz-centered therapies in treatment-naïve and switch patients due to safety, tolerability, and resistance profile advantages.
• Tolerability headwinds: Efavirenz is associated with central nervous system adverse effects and psychiatric events, which increased clinician and patient preference for alternatives when available.
• Formulary pressure: Public-sector and payer formularies shifted toward INSTI-containing regimens, compressing efavirenz’s addressable market.
• Generic penetration: Once patent and exclusivity barriers fell, lower-cost generics drove price compression and brand share erosion.

Where SUSTIVA can still hold volume

• Legacy persistence: Patients already on efavirenz-based regimens can remain stable when virologically suppressed, especially if switching triggers risk or logistical burdens.
• Procurement frameworks: National HIV programs and large tenders can maintain efavirenz supply if it meets budget and procurement criteria, particularly for second-line or specific program designs.

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What are the main market dynamics shaping SUSTIVA demand (HIV procurement vs payer vs retail)?

Short answer: SUSTIVA is largely a supply and procurement product. Demand is shaped by tender cycles, WHO and national program guidance, and regimen selection rules tied to budgets.

Channel structure

• Institutional procurement: The biggest share historically came from public procurement for HIV programs. These buys respond to tender pricing and availability.
• Hospital/clinic formularies: Treatment switching policies influence share. Many clinicians prefer modern regimens where guideline-concordant.
• Retail pharmacy: In some markets, brand presence persisted longer, but volume is generally smaller than institutional demand in HIV.

Pricing and margin implications

• Brand-to-generic spread: As generic efavirenz products entered, average selling prices (ASPs) for brand fell, even where brand remained listed.
• Tender-driven price discovery: In public tenders, the lowest effective price dominates awarded volume, limiting premium pricing for branded products.

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When does SUSTIVA lose exclusivity, and how does that timeline impact revenue?

Short answer: Efavirenz’s US and major market exclusivity largely moved into the generics era years ago, making revenue impact primarily historical. Any remaining brand revenue is tied to residual lifecycle effects, switching inertia, and FDC-specific arrangements in certain jurisdictions.

Key exclusivity mechanics (how they typically affect efavirenz)

• Composition-of-matter expirations: Drive broad generic entry for efavirenz tablets and capsules.
• Newer patent thickets: Sometimes extend exclusivity for specific formulations, strengths, or FDC combinations, but these are narrower than the base drug’s core compound protection.
• Regulatory exclusivity is unlikely to be the main lever for long-established APIs: For a mature molecule like efavirenz, exclusivity is more often governed by patent status and generic freedom-to-operate than by new regulatory exclusivity grants.

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What patents and Orange Book status affect generic entry for efavirenz products?

Short answer: Patent status for efavirenz is the central determinant of the scope and timing of generic entry, but broad generics are already widely available. The financial model today depends less on future patent cliffs and more on whether any protected FDC or formulation variants still exist in specific markets.

How to interpret “Orange Book” relevance for an older HIV drug

• Orange Book coverage is most relevant for US-listed drug products and any remaining listed patents tied to those products.
• For older drugs, many filings are either expired or already cleared for generics, which reduces the likelihood of new, brand-protecting exclusivity in the US.

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Which generic versions of efavirenz compete with SUSTIVA, and what is their pricing power?

Short answer: Multiple generic efavirenz products compete, and generic pricing is the primary force behind brand share erosion. Competitive dynamics depend on who wins tenders and who can meet scale and stability requirements.

Competitive pressure profile

• Multiple-source risk: Efavirenz is widely generically available, reducing pricing power for a single brand product.
• Tender favoritism: Procurement agencies often award to multiple suppliers only if price and supply meet criteria, which compresses margins across the branded channel.
• Supply reliability: For mature APIs, supply chain reliability can become the differentiator more than innovation.

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How do newer HIV regimens change SUSTIVA’s addressable market?

Short answer: INSTI-based regimens shrink efavirenz’s addressable patient pool and accelerate switching where formularies permit.

Substitution pathways

• Treatment-naïve shift: Clinicians increasingly select INSTI-centered regimens as first-line.
• Switch for tolerability: Patients may switch off efavirenz due to CNS adverse effects.
• Resistance and regimen design: Regimen architecture and drug-drug interactions can make INSTIs more attractive for many clinical profiles.

Net market effect

• Lower new-start volumes for efavirenz.
• Increased patient churn away from efavirenz where guidelines and payer coverage allow.

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How do fixed-dose combinations (FDCs) that include efavirenz affect SUSTIVA brand outcomes?

Short answer: FDCs can extend efavirenz presence even as standalone efavirenz loses share. If efavirenz remains in specific FDC SKUs in certain regions, demand can persist in those channels despite standalone brand decline.

Commercial implication

• Brand competition may move from “SUSTIVA tablets vs generics” to “efavirenz-containing FDC vs alternative FDCs,” where pricing and procurement rules dominate.

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What litigation and settlement dynamics historically influenced efavirenz or SUSTIVA?

Short answer: Generic entry for mature HIV drugs is typically shaped by patent litigation and settlement agreements, but the current commercial posture reflects broad generic availability. The revenue trajectory is therefore more consistent with post-entry price compression than with litigation-driven delay in today’s market.

Litigation’s economic role

• Settlement terms can delay generic launches in specific product configurations or strengths.
• Post-settlement entry generally accelerates revenue decline once brand-market restrictions end.

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What is the financial trajectory risk: “brand survival” vs “volume commoditization”?

Short answer: Efavirenz’s financial risk profile is volume commoditization. When a drug becomes a standard generic commodity, revenue depends on contracts and supply, not on brand differentiation.

Key risk factors

• Formulary exclusion risk: Continued guideline alignment with INSTI regimens erodes new patient starts.
• Price erosion risk: Generic competition caps pricing and margin.
• Program tender volatility: Single tender outcomes can swing volumes significantly.
• FDC substitution: Shifts from efavirenz-containing FDCs to alternative FDCs reduce residual demand.

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How does SUSTIVA compare with modern NNRTIs and INSTI-based competitors on commercial dynamics?

Short answer: Modern regimens win on dosing convenience, tolerability, and guideline positioning. Efavirenz’s commercial advantage is mainly legacy and procurement familiarity.

Commercial comparison lens

• In-market differentiation: Minimal versus modern INSTI regimens once generic efavirenz is available.
• Clinical uptake: Faster shift away from efavirenz when alternatives are preferred.
• Payer coverage: INSTI-based regimens are increasingly covered as default for many populations.

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Key drivers that still support efavirenz volumes despite decline

Short answer: residual effectiveness, stability in suppressed patients, and procurement economics in large programs.

Where efavirenz still fits

• Patients already suppressed: clinicians may keep therapy stable.
• Budget-constrained programs: efavirenz pricing can be favorable versus alternatives where no generics or higher-priced regimens dominate.
• Policy continuity: some national programs continue older regimen strategies for operational reasons.

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Key Takeaways

1. SUSTIVA’s market is shaped by generic commoditization and regimen substitution, not by brand-protected growth.
2. Revenue trajectory is dominated by volume decline from INSTI-based standard-of-care and price compression after generic entry.
3. Residual demand is sustained by legacy patient persistence and procurement economics, including efavirenz-containing FDCs in certain geographies.
4. Forward-looking financial risk is highest in formulary exclusion and tender-driven price collapse, with limited upside unless protected FDC or formulation variants exist in specific markets.

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FAQs

1. What HIV treatment guidelines most directly displace efavirenz-based regimens from first-line use?
2. How do public-sector tender cycles influence efavirenz procurement and quarterly revenue volatility?
3. Do efavirenz-containing fixed-dose combinations retain longer commercial life than standalone efavirenz tablets?
4. What safety and tolerability considerations drive clinician switching away from efavirenz?
5. How do generic supply constraints and multiple-source availability affect efavirenz pricing during high-demand periods?

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References

1. World Health Organization. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring. WHO; latest editions cited on WHO website.
2. FDA. Drugs@FDA database for efavirenz-containing products and labeling history. US Food and Drug Administration.
3. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations for efavirenz-related listed patents and approvals. US Food and Drug Administration.
4. Gilead / industry and public sources on HIV regimen evolution toward INSTI-based therapies (guideline and literature summaries available in public domain).