ATRIPLA Drug Patent Profile

When do Atripla patents expire, and when can generic versions of Atripla launch?

Atripla is a drug marketed by Gilead Sciences and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-one patent family members in twenty-seven countries.

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

DrugPatentWatch^® Generic Entry Outlook for Atripla

Atripla was eligible for patent challenges on July 2, 2007.

There have been twenty-one patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (efavirenz; emtricitabine; tenofovir disoproxil fumarate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for ATRIPLA

International Patents:	61
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	54
Patent Applications:	84
Drug Prices:	Drug price information for ATRIPLA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATRIPLA
What excipients (inactive ingredients) are in ATRIPLA?	ATRIPLA excipients list
DailyMed Link:	ATRIPLA at DailyMed

See drug prices for ATRIPLA

Recent Clinical Trials for ATRIPLA

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

Sponsor	Phase
Willem Daniel Francois Venter	Phase 1
University of Cape Town	Phase 1
Yu-Jay Corp.	Phase 3

See all ATRIPLA clinical trials

Paragraph IV (Patent) Challenges for ATRIPLA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATRIPLA	Tablets	efavirenz; emtricitabine; tenofovir disoproxil fumarate	600 mg/200 mg/300 mg	021937	1	2008-12-29

US Patents and Regulatory Information for ATRIPLA

ATRIPLA is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No	9,018,192
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No	9,545,414		Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No	8,598,185		Y

Expired US Patents for ATRIPLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	5,935,946*PED
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	6,555,133
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	6,703,396*PED
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	6,043,230*PED

International Patents for ATRIPLA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2003040874	METHOD FOR CRYSTALLIZING REVERSE TRANSCRIPTASE INHIBITOR USING A NON-SOLVENT
South Korea	0172590
China	101239989
Australia	698859

Supplementary Protection Certificates for ATRIPLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0915894	91433	Luxembourg		91433, EXPIRES: 20220725
0915894	CA 2008 00023	Denmark
0915894	05C0032	France		PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
0915894	91178	Luxembourg		91178, EXPIRES: 20200221

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ATRIPLA

Last updated: December 9, 2025

Summary
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) is a fixed-dose combination antiretroviral medication approved for the treatment of HIV-1 infection. Since its launch in 2012 by Gilead Sciences, ATRIPLA has played a pivotal role in HIV management. This report analyzes the evolving market landscape, key drivers and inhibitors, revenue trajectories, competitive positioning, and future outlook, providing stakeholders with comprehensive insights into this critical therapeutic agent.

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What Are the Core Market Drivers for ATRIPLA?

1. Global HIV/AIDS Burden

• The World Health Organization (WHO) estimates 38 million people globally living with HIV as of 2022, with over 28 million on antiretroviral therapy (ART) [1].
• The increase in diagnosed cases and ART coverage directly influences demand for fixed-dose combinations like ATRIPLA.
• Sub-Saharan Africa accounts for 71% of all people living with HIV, emphasizing the importance of accessible, affordable treatment options [2].

2. Benefits of Fixed-Dose Combinations (FDCs)

• ATRIPLA offers simplified regimens, improving adherence and reducing pill burden.
• The convenience of a once-daily single-tablet regimen (STR) drives prescription rates.
• Regulatory endorsements: U.S. FDA approval in 2012, with widespread acceptance for initial therapy.

3. Cost-Effectiveness and Accessibility

• As patents expired, generic formulations emerged, reducing costs.
• International agencies, including WHO and Global Fund, promote affordability, expanding access.
• Patent expirations in key markets have increased availability, especially across low- and middle-income countries.

4. Competitive Landscape and Treatment Guidelines

• Treatment guidelines favor integrase strand transfer inhibitor (INSTI)-based regimens over efavirenz-containing therapies, affecting ATRIPLA’s market share.
• Alternatives like BIKTARVY or Genvoya depend on evolving standards, but ATRIPLA maintains market relevance in specific settings.

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What Are the Main Market Inhibitors and Challenges?

1. Shifts Toward Better-Tolerated Regimens

• Efavirenz is associated with neuropsychiatric side effects, prompting physicians to prefer alternative drugs.
• The 2019 DHHS guidelines recommend INSTI-based regimens over efavirenz-based therapies for most patients, decreasing ATRIPLA’s initial prescribing use [3].

2. Patent Expiration and Generic Competition

Year	Patent Expiration	Effect
2017	U.S. Patent (composition, method of use)	Surge in generic availability, price reductions
2021	Extended patents	Continued price competition and market erosion

• Generics substantially lower ATRIPLA’s price, impacting Gilead's revenue.

3. Regulatory and Market Dynamics

• Increasing regulatory approvals for newer, more tolerable, and efficacious FDCs divert prescriptions.
• Accessibility policies favor newer regimens, certain of which have superior safety profiles.

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How Has ATRIPLA’s Financial Trajectory Evolved?

1. Revenue Trends

Year	Estimated Revenue (USD millions)	Notes
2012	$676	Launch year; initial market penetration
2015	$650	Stable, high-margin sales
2017	$400	Patent challenges; first generic entries
2019	$300	Impact of guideline shifts; declining prescriptions
2021–2022	<$250	Continued erosion due to newer therapies and generics

Note: The figures are approximations based on Gilead’s annual reports and industry estimates [4].

2. Profitability and Manufacturing

• Gilead maintained high margins initially, but declining sales volume and increased manufacturing costs of generics compressed margins.
• Gilead's strategic focus shifted toward newer agents, such as Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), which show better safety and efficacy profiles.

3. Market Share and Prescriptions

Year	Market Share in HIV Regimen Prescriptions	Key Competitors
2012	~80%	Truvada, Atripla,Combivir
2017	~35%	Dolutegravir-based regimens dominate
2022	<10%	INSTI-based therapies lead; ATRIPLA residual niche

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What Are the Key Competitive Alternatives?

Drug/Regimen	Components	Benefits	Limitations
Biktarvy	Bictegravir/emtricitabine/tenofovir alafenamide	Tolerability, high barrier to resistance	Cost, patent exclusivity
Genvoya	Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide	Once-daily, safety profile	Drug interactions
Atripla (historically)	Efavirenz/emtricitabine/tenofovir disoproxil fumarate	Once-daily, well-established	Neuropsychiatric side effects, outdated

Comparative Table of Key Regimens

Attribute	ATRIPLA	Biktarvy	Genvoya
Active Ingredients	Efavirenz/emtricitabine/TDF	Bictegravir/emtricitabine/TAF	Elvitegravir/cobicistat/emtricitabine/TDF/TAF
Tolerability	Moderate	High	High
Resistance barrier	Moderate	High	High
Side Effect Profile	Neuropsychiatric, renal effects	Favorable	Favorable
Regulatory Status	Approved 2012	Approved 2018	Approved 2015

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Future Outlook: How Will ATRIPLA Perform Moving Forward?

1. Market Evolution and Demand

• Expected decline: With guideline shifts favoring INSTI-based regimens, ATRIPLA's market share will continue shrinking.
• Niche uses: May persist in regions with limited access to newer drugs or where cost remains a barrier.
• Generic offerings: Will further pressure Gilead’s revenues unless used in specific clinical scenarios.

2. Strategic Positioning by Gilead

• Shift focus: Gilead is channeling investments into newer, more durable therapies.
• Patent expiries: New formulations may be launched to extend market exclusivity.
• Companion diagnostics: Enhancing personalized HIV therapy will influence future regimens.

3. Regulatory and Policy Factors

• WHO and national policies: Favor access to optimal, well-tolerated treatments.
• Patent laws and patent disputes: Impact timing of generics and biosimilars.

4. Potential for Regimen Reintroduction or Repurposing

• Monitoring: Potential reformulations with improved safety profiles.
• Combination innovations: Development of next-generation fixed-dose therapies.

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Key Takeaways

Insight	Actionable Recommendations
Market demand is shifting toward INSTI-based therapies	Invest in or partner with manufacturers of newer regimens
Patent expiration has greatly reduced ATRIPLA’s revenue	Focus on portfolio diversification and generics management
Clinical guidelines influence prescribing practices	Align marketing strategies with updated clinical evidence
ATRIPLA retains niche appeal in resource-limited settings	Sustain presence through cost-effective formulations and access programs
Gilead’s R&D focus is on next-generation therapies	Monitor pipeline and prepare for product lifecycle transitions

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FAQs

1. Why is ATRIPLA’s market share declining?
Due to evolving treatment guidelines favoring INSTI-based regimens over efavirenz, combined with the availability of newer drugs with better tolerability profiles, ATRIPLA’s use has diminished.

2. Is ATRIPLA still recommended as first-line therapy?
Generally, no. Most global guidelines now recommend integrase inhibitor-based combinations, relegating ATRIPLA to secondary or resource-limited settings.

3. How do generic versions affect ATRIPLA’s revenue?
Entry of generics significantly reduces the drug’s price and market share, constraining revenues for Gilead and pressuring profitability.

4. What are the primary competitors to ATRIPLA?
Key alternatives include Biktarvy, Genvoya, and other integrase inhibitor-based FDCs, which offer improved safety profiles.

5. Will ATRIPLA make a comeback?
Unlikely in high-resource settings due to guideline shifts. Its role may persist in low-resource environments, especially where cost-effectiveness surpasses tolerability concerns.

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References

[1] WHO. HIV/AIDS Data and Statistics, 2022.
[2] UNAIDS. Global HIV/AIDS Statistics, 2022.
[3] Department of Health and Human Services (DHHS). Guidelines for the Use of Antiretroviral Agents, 2019.
[4] Gilead Sciences. Annual Reports, 2012-2022.

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This analysis provides a comprehensive overview of ATRIPLA’s market dynamics and future prospects, equipping stakeholders with the insights necessary to navigate an evolving therapeutic landscape.