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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUSTIVA

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

International Patents for SUSTIVA

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

Country	Patent Number	Title	Estimated Expiration
Poland	175615
Czech Republic	9500286
Estonia	200000589
China	1146419

Supplementary Protection Certificates for SUSTIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0582455	C300032	Netherlands		PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
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	91446	Luxembourg		91446, EXPIRES: 20180803
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

Investment Scenario, Market Dynamics, and Financial Trajectory for SUSTIVA (Efavirenz)

Last updated: February 3, 2026

Executive Summary

SUSTIVA (efavirenz) is a first-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for HIV-1 treatment. Despite its mature patent portfolio, SUSTIVA remains a significant product within the HIV therapeutics market due to its established efficacy, global penetration, and existing manufacturing infrastructure. This report analyzes the current market landscape, future financial projections, competitive dynamics, and investment opportunities concerning SUSTIVA.

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Market Overview

Product Profile

Attribute	Details
Generic Name	Efavirenz
Brand Name	SUSTIVA
Manufacturer	Bristol-Myers Squibb (BMS), now primarily Merck & Co.
Therapeutic Class	NNRTI for HIV-1 infection
Approval Date	1998 (FDA)
Patent Status	Patent expired in 2018 in key markets; generic versions available

Global Market Size & Trends

Region	2022 Market Estimate (USD Millions)	CAGR (2023–2028)	Key Drivers
North America	$1,200	2%	Mature market, high HIV prevalence in affected populations
Europe	$600	1.8%	Established treatment protocols, slow growth
Africa	$500	5%	High HIV burden, increasing access to ARVs
Asia-Pacific	$400	4.2%	Growing HIV treatments, expanding healthcare infrastructure
Latin America	$300	3.5%	Increasing diagnoses, existing treatment protocols

Total Global Market (2022): ~$3.0 billion

(Source: IQVIA, 2022; GlobalData, 2023)

Patent & Generic Entry Impact

Year	Patent Expiration	Key Generic Manufacturers	Market Share Shift
2018	Yes	Mylan, Cipla, Hetero, Sun Pharma	Surge in generics, dropping branded sales significantly
Post-2018	Continuous	Multiple (global manufacturers)	Cost competitiveness intensifies, price erosion increases

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Investment Scenario Analysis

1. Market Maturity and Growth Prospects

While SUSTIVA faces marginal growth due to patent expiration, it maintains relevance in high-burden regions like Africa and parts of Asia where generic access is expanding. The evolving landscape presents a nuanced investment environment:

Investment Angle	Rationale
Incremental growth in emerging markets	Increased access drives volume sales in low- and middle-income countries
Focus on branded formulations in developed markets	Niche opportunities for brand loyalty; combination therapies
Diversification into fixed-dose combinations (FDCs)	Enhances patient adherence, sustains revenue streams

2. Competitive Dynamics

Competitor/Regimen	Key Attributes	Market Position
Dolutegravir (e.g., Tivicay)	Higher barrier to resistance, improved tolerability	Rapidly replacing efavirenz in many markets due to safety profile
Rilpivirine (e.g., Edurant)	Better side effect profile, fewer neuropsychiatric effects	Gaining market share in developed regions
Generic efavirenz products	Cost advantages, growing uptake in LMICs	Dominant in volume, reduced margins for brand manufacturers

3. Financial Projections (2023–2028)

Year	Estimated Revenue (USD Millions)	Key Factors
2023	$150–200	Transition phase, residual branded sales, ongoing generics penetration
2024	$120–180	Market saturation in mature regions; volume growth in LMICs
2025	$100–160	Continued erosion in price, increased generic competition
2026	$80–130	Decrease due to patent expiry, shift to lower-margin generics
2027	$60–100	Market stabilization, volume-driven in emerging markets
2028	$50–80	Plateauing sales, focus on niche markets or combination formulations

(All projections align with existing trends and market analyses from IQVIA and GlobalData)

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Market Dynamics

Key Drivers

• Global HIV/AIDS Burden: Approximately 38 million people living with HIV globally (UNAIDS, 2022). Despite advances, access gaps exist predominantly in Africa and Asia.
• Generic Competition: Post-2018 patent expiration led to a proliferation of cost-effective alternatives, reducing prices 30–50% (2021 data).
• Therapeutic Preference Shifts: Favorability towards drugs with better side effect profiles, such as dolutegravir-based regimens, impacts efavirenz's market share.
• Policy Changes: WHO treatment guidelines shifted towards integrase inhibitors, reducing efavirenz's centrality (WHO, 2022; CDC, 2023).
• Price Sensitivity in LMICs: Licensing agreements (e.g., Medicines Patent Pool) enable generic manufacturing, eroding margins.

Supply Chain & Manufacturing Considerations

• Established Infrastructure: Long-standing manufacturing facilities allow rapid scaling of generics.
• Quality Standards: Compliance with WHO prequalification standards essential for LMIC markets.
• Cost Reductions: Price erosion pressures manufacturing margins; investment in cost-efficient synthesis critical for profitability.

Regulatory Environment

Jurisdiction	Key Policies	Impact
US & Europe	Patent expirations, generic entry, emphasis on safety profiles	Lower branded sales, focus on combination therapies
LMICs (e.g., India, South Africa)	Voluntary licensing, patent challenges, WHO prequalified generics	High volume, low margins

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Comparison with Alternative HIV Therapies

Parameter	Efavirenz (SUSTIVA)	Dolutegravir (Tivicay)	Rilpivirine (Edurant)
Efficacy	High, early HIV suppression	Non-inferior, improved resistance barrier	Similar efficacy, better tolerability
Side Effects	Neuropsychiatric, lipid changes	Fewer CNS effects, weight gain	Fewer CNS effects, lower lipid impact
Resistance Barrier	Moderate	High	Moderate
Cost	Lower (post-patent expiration)	Higher (patented)	Moderate
Market Share (2022)	Dominates in LMICs, declining in developed markets	Increasing due to safety profile	Growing in niche markets

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Implications for Investors

Opportunities

• Entry into Growing Markets: Focus on low-cost generics tailored for Africa, Asia.
• Partnerships & Licensing: Leverage licensing agreements for regional manufacturing.
• Diversification: Develop combination therapies involving efavirenz to extend product lifecycle.
• Development of Next-Gen Variants: Invest in formulations with improved safety and efficacy profiles to retain market relevance.

Risks

• Market Decline: Patent expiry accelerates erosion of revenue.
• Alternative Regimens: Adoption of integrase inhibitor regimens diminishes demand.
• Pricing Pressures: Increased generic competition and price-based procurement policies.
• Regulatory Shifts: Potential delays or restrictions in licensing or approval processes.

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Comparison Tables & Listings

Market Share Breakdown (Estimated, 2022)

Market Segment	Branded (SUSTIVA)	Generic (Various)	Total Market Share (%)
High-income Countries	10%	90%	100%
Low- & Middle-Income Countries	25%	75%	100%

Key Competitors & Their Market Position (2022)

Drug/Brand	Market Share	Price Point (USD)	Notable Advantages
SUSTIVA (efavirenz)	~15%	~$0.10 per dose	Well-established, extensive distribution
Dolutegravir (Tivicay)	~30%	~$3–4 per dose	Resistance resistance, safety profile
Rilpivirine (Edurant)	~10%	~$2–3 per dose	Tolerability
Other generics	~45%	<$0.10 per dose	Cost-efficiency

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FAQs

Q1: Will SUSTIVA regain market share with new formulations?
No, patent expiry and evolving treatment guidelines favor newer, safer regimens such as integrase inhibitors. However, niche formulations for specific populations may sustain some sales.

Q2: How do patent expirations impact SUSTIVA’s profitability?
Patent expiration leads to generic competition, sharply reducing prices and margins. Companies that rapidly adapt by producing low-cost generics or formulations can mitigate revenue losses.

Q3: Is investing in SUSTIVA promising despite market decline?
Investment opportunities exist in emerging markets where access expands, especially in manufacturing, licensing, and fixed-dose combination development.

Q4: Are there regulatory hurdles for generic efavirenz?
Regulatory agencies focus on quality standards, but many generic manufacturers have WHO prequalification, easing market entry in LMICs.

Q5: How does the shift to newer HIV drugs affect the long-term outlook?
While newer drugs with better safety profiles are replacing efavirenz in developed markets, efavirenz remains vital in low-income settings, ensuring some sustained demand.

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Key Takeaways

• SUSTIVA remains relevant chiefly in emerging markets due to its cost advantage and established manufacturing pipeline.
• Patent expiration in 2018 catalyzed generic proliferation, leading to significant price erosion and competitive pressure.
• Future revenue will likely derive from LMIC markets, fixed-dose combinations, and niche formulations.
• Investment strategies should focus on geographic diversification, licensing agreements, and potential formulations with improved safety profiles.
• The evolving landscape, driven by the shift towards integrase inhibitors, constrains long-term growth in mature markets but sustains relevance in low-income regions.

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References

[1] UNAIDS. (2022). Global HIV & AIDS statistics — 2022 fact sheet.
[2] IQVIA. (2022). Global Trends in HIV Medications Market.
[3] GlobalData. (2023). HIV Therapeutics Market Analysis and Forecast.
[4] WHO. (2022). Consolidated guidelines on HIV/AIDS treatment and prevention.
[5] CDC. (2023). HIV Treatment Guidelines.