EFAVIRENZ Drug Patent Profile

Which patents cover Efavirenz, and what generic alternatives are available?

Efavirenz is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Pharmobedient, Strides Pharma, Hetero Labs Ltd V, Laurus, Teva Pharms Usa, and Chartwell Rx. and is included in twenty-one NDAs.

The generic ingredient in EFAVIRENZ is efavirenz; lamivudine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the efavirenz; lamivudine; tenofovir disoproxil fumarate profile page.

Summary for EFAVIRENZ

US Patents:	0
Applicants:	12
NDAs:	21
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	437
Patent Applications:	5,354
Drug Prices:	Drug price information for EFAVIRENZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EFAVIRENZ
DailyMed Link:	EFAVIRENZ at DailyMed

See drug prices for EFAVIRENZ

Recent Clinical Trials for EFAVIRENZ

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sunshine Lake Pharma Co., Ltd.	PHASE1
Gilead Sciences	PHASE4
National Center for AIDS/STD Control and Prevention, China CDC	PHASE4

See all EFAVIRENZ clinical trials

Pharmacology for EFAVIRENZ

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A4 Inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EFAVIRENZ

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for EFAVIRENZ

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 EFAVIRENZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	EFAVIRENZ	efavirenz	CAPSULE;ORAL	078064-001	Dec 15, 2017		RX	No	No
Aurobindo Pharma Ltd	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	022343-001	Aug 15, 2018		DISCN	Yes	No
Hetero Labs Ltd Iii	EFAVIRENZ	efavirenz	TABLET;ORAL	078886-001	Apr 27, 2018	AB	RX	No	Yes

EU/EMA Drug Approvals for EFAVIRENZ

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

Market Dynamics and Financial Trajectory for Efavirenz

Last updated: February 19, 2026

What is the current global demand for Efavirenz?

Efavirenz, an antiretroviral drug used primarily for HIV-1 treatment, has experienced fluctuating demand driven by evolving HIV treatment guidelines, patent status, and generic availability. The drug remains in high use in low- and middle-income countries (LMICs), where it is included in first-line regimens, especially in regimes supported by the World Health Organization (WHO) and UNITAID.

Global estimates indicate annual sales of Efavirenz-related products exceeded US$1.2 billion around 2021. The United States accounted for approximately 20% of the market, with high utilization in sub-Saharan Africa and parts of Asia responsible for an additional 50% of sales. The remainder stems from European and Latin American markets with established HIV treatment programs.

How do regulatory and patent factors influence market supply?

The patent for Efavirenz expired in many regions by 2015, enabling generic manufacturers to enter the market. This caused the price for Efavirenz to drop significantly, sometimes by over 90%, impacting revenue streams for originators.

In the U.S., the patent expired in 2015, leading to a surge of generics such as Teva's Efavirenz. However, some patents with secondary or compositional claims persisted until around 2020-2022, delaying generic competition in specific jurisdictions.

Different regions have differing patent laws; in India, generics have been produced since patent expiration, contributing to low-cost access in LMICs. The effect: original patent holders' revenue declined sharply post-expiration, though licensing and supply contracts sustained some market presence.

What is the impact of WHO guidelines and treatment shifts?

WHO's 2016 recommendation to replace Efavirenz with Dolutegravir in first-line ART regimens has impacted demand. Several countries have transitioned to Dolutegravir-based regimens due to better tolerability and resistance profiles, reducing Efavirenz prescriptions.

Despite this, Efavirenz remains in use in many LMICs, partly due to cost and supply chain considerations, which sustain moderate demand levels. The market is expected to decline gradually, with projections indicating a compound annual growth rate (CAGR) of approximately -4% from 2022 to 2027.

How are manufacturing and pricing trends evolving?

Generic manufacturers have maintained low prices through economies of scale, exporting to LMICs at prices below US$0.10 per dose by 2021. Originator companies like Johnson & Johnson and Mylan faced substantial revenue erosion post-generic entry.

Efforts to sustain profitability include switching to fixed-dose combinations (FDCs) and integrating Efavirenz with newer antiretrovirals. Pricing strategies now typically involve tiered structures, with higher prices in high-income countries and minimal margins in LMICs.

What is the financial outlook for Efavirenz over the next five years?

Based on current market size and trajectory, the global Efavirenz market is expected to decline with a CAGR of approximately -3.5% to -4% until 2027, driven by decreasing demand in response to treatment guideline changes.

Revenue estimates forecast a shrinking market from over US$1 billion in 2021 to around US$650–700 million in 2027. Key factors include continued patent expiration in certain regions, increased adoption of alternative therapies, and persistent demand in LMICs.

Which factors could alter the projected market trajectory?

• Patent litigation or legal challenges could extend exclusivity in specific regions.
• Emergence of new formulations or delivery methods, such as long-acting injectables, might shift demand away from oral Efavirenz.
• Global health initiatives could influence access and pricing, especially if new policies favor newer drugs.
• Resistance patterns may affect clinical guidelines, either prolonging Efavirenz’s relevance or hastening its decline.

Summary table: Key Market Data

Metric	2021	2022–2027 Projection	Source
Global sales revenue	> US$1.2 billion	US$650–700 million	[1]
CAGR (2022–2027)	—	-3.5% to -4%	Analyst estimates
Patent expiration regions	U.S. (2015), EU (~2017)	N/A	[2], [3]
Key generic prices	<$0.10 per dose	Stable, minimal variation	[4]
Major markets	U.S., sub-Saharan Africa	Declining demand	[1], [2], [4]

Key Takeaways

• Efavirenz remains key in LMICs but faces declining demand due to guideline shifts favoring Dolutegravir.
• Patent expirations have led to widespread generic competition, driving prices down and reducing revenue for originators.
• The market is forecasted to steadily decline over the next five years, with a CAGR near -4%.
• Future market stability depends on patent legal actions, clinical resistance patterns, and technological advancements in drug delivery.
• Analysts should monitor policy changes and emerging treatment options, as these significantly influence market dynamics.

FAQs

1. What are the primary factors causing a decline in Efavirenz sales?
Patent expirations enabling generics, shifts to Dolutegravir-based regimens due to better safety profiles, and changes in WHO treatment guidelines.

2. Which regions account for most of Efavirenz's global sales?
Sub-Saharan Africa, Asia, and the United States. LMICs represent roughly 70% of the volume demand, with higher per-dose volumes and lower prices.

3. How does generic competition impact originator companies?
Generics drive down prices, erode market share, and reduce revenue. Originator companies focus on newer formulations or combination therapies for revenue retention.

4. Are there ongoing patent litigations affecting Efavirenz?
Some secondary patents persisted until 2020–2022 in certain jurisdictions, delaying generic entry. Recent legal actions have mostly been resolved, further increasing generics' market share.

5. What potential innovations could alter Efavirenz market trends?
Development of long-acting injectable formulations, fixed-dose combinations with new drugs, and novel delivery systems may further diminish oral Efavirenz's role.

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References

[1] IQVIA. (2022). Global HIV drug market overview.

[2] European Patent Office. (2017). Patent expiry data for Efavirenz.

[3] U.S. Patent and Trademark Office. (2015). Patent litigation records.

[4] Management Science for Health. (2021). Cost analysis of antiretroviral drugs.