EVOTAZ Drug Patent Profile

Which patents cover Evotaz, and when can generic versions of Evotaz launch?

Evotaz is a drug marketed by Bristol and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and five patent family members in forty-one countries.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atazanavir sulfate; cobicistat profile page.

DrugPatentWatch^® Generic Entry Outlook for Evotaz

Evotaz was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 6, 2032. This may change due to patent challenges or generic licensing.

There have been eight 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.

Indicators of Generic Entry

Summary for EVOTAZ

International Patents:	305
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Drug Prices:	Drug price information for EVOTAZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVOTAZ
What excipients (inactive ingredients) are in EVOTAZ?	EVOTAZ excipients list
DailyMed Link:	EVOTAZ at DailyMed

See drug prices for EVOTAZ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EVOTAZ

Constraining patent/regulatory exclusivity:

10,039,718

NDA:

206353

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EVOTAZ

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

Sponsor	Phase
Gilead Sciences	Phase 3
Bristol-Myers Squibb	Phase 1
St Stephens Aids Trust	Phase 1

See all EVOTAZ clinical trials

Pharmacology for EVOTAZ

Drug Class

Cytochrome P450 3A Inhibitor Protease Inhibitor

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors UDP Glucuronosyltransferases Inhibitors UGT1A1 Inhibitors

Paragraph IV (Patent) Challenges for EVOTAZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EVOTAZ	Tablets	atazanavir sulfate; cobicistat	300 mg/150 mg	206353	1	2017-09-13

US Patents and Regulatory Information for EVOTAZ

EVOTAZ is protected by two US patents.

This potential generic entry date is based on patent 10,039,718.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015		RX	Yes	Yes	8,148,374		Y	Y
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015		RX	Yes	Yes	10,039,718		Y

Expired US Patents for EVOTAZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015	5,849,911*PED
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015	6,087,383*PED

International Patents for EVOTAZ

When does loss-of-exclusivity occur for EVOTAZ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Peru

Poland

Portugal

San Marino

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EVOTAZ around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101636221
Hong Kong	1126485
Spain	2779826

Supplementary Protection Certificates for EVOTAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	17C1000	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER LE SULFATE D'ATAZANAVIR; REGISTRATION NO/DATE: EU/1/15/1025 20150715
0900210	SPC023/2005	Ireland		SPC023/2005, 20060612, EXPIRES: 20190301
2487162	122016000103	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/14/967 20141119

Market Dynamics and Financial Trajectory for EVOTAZ

Last updated: July 27, 2025

Introduction

EVOTAZ, a fixed-dose combination antiretroviral therapy (ART), has established itself as a critical component in managing HIV/AIDS. Developed by Gilead Sciences, EVOTAZ combines atazanavir (300 mg) with cobicistat (150 mg) into a single daily pill. Since its regulatory approval, EVOTAZ's position within the antiretroviral landscape has been shaped by evolving market dynamics, competitive pressures, regulatory shifts, and pipeline developments. This analysis explores these factors to delineate EVOTAZ's current market trajectory and future financial outlook.

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Market Overview and Demand Drivers

Global HIV/AIDS Burden

The persistent global prevalence of HIV/AIDS remains the primary demand driver for EVOTAZ. According to UNAIDS, approximately 38 million people worldwide are living with HIV/AIDS, with over 25 million on antiretroviral therapy as of 2021 [1]. The increasing scale of treatment, particularly in low- and middle-income countries, sustains steady demand for fixed-dose combination therapies like EVOTAZ.

Treatment Guidelines and Adoption Trends

International guidelines, notably those from the World Health Organization (WHO) and the U.S. Department of Health and Human Services (HHS), endorse integrase strand transfer inhibitor (INSTI)-based regimens as first-line therapies. Nonetheless, protease inhibitors (PIs) such as atazanavir maintain a role, especially in treatment-resistant cases or patients with contraindications to INSTIs [2]. The convenience of EVOTAZ's once-daily dosing supports its continued utilization; however, adoption varies by region and clinician preference.

Market Segmentation and Competition

EVOTAZ primarily competes in the PI-based ART segment, contending with rivals such as Darunavir-based formulations, and newer integrase inhibitor regimens like Dolutegravir-based therapies. The proliferation of generic PIs, particularly in low-income countries, significantly impacts EVOTAZ's market share by offering lower-cost alternatives. Moreover, emerging long-acting injectables further threaten the demand for daily oral regimens [3].

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Regulatory and Intellectual Property Landscape

Patent Status and Exclusivity

Gilead holds patents on EVOTAZ, providing market exclusivity until approximately 2030–2032 in key jurisdictions. Patent disputes and potential patent expirations could erode revenue streams and open opportunities for generic competition. The company actively defends its intellectual property rights, while regulatory agencies evaluate generic applications, influencing market access timelines.

Regulatory Approvals and Strategic Moves

Beyond initial approval, Gilead has secured regional clearances, expanding EVOTAZ's availability. However, regulatory shifts advocating for more affordable options and simplified regimens pose challenges. Gilead's strategy emphasizes lifecycle management, including new formulations and longer patents, to sustain market presence.

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Competitive Dynamics and Market Share Evolution

Impact of Alternative Regimens

The rising preference for integrase inhibitor-based regimens, owing to better tolerability and fewer drug interactions, has curtailed the growth of PI-based therapies like EVOTAZ. For instance, the availability of once-daily, low-pill-count regimens such as Genvoya and Biktarvy has undercut EVOTAZ's market share, especially among treatment-naïve patients.

Generic Entry and Price Competition

In numerous regions, generic versions of atazanavir and cobicistat have entered the market, offering cost advantages that diminish EVOTAZ's revenue potential. For example, India and South Africa feature several generics, driving down prices and affecting Gilead’s profitability.

Emerging Market Strategies

Gilead's expansion into emerging markets involves local manufacturing partnerships and pricing adjustments to maintain competitiveness. However, price-sensitive markets prioritize generics, constraining EVOTAZ’s growth potential in these regions.

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Financial Trajectory and Revenue Outlook

Historical Performance

EVOTAZ generated approximately $X billion in global sales in 2021, with steady growth in high-income markets but declining margins in low-resource settings due to price competition [4]. The product contributed significantly to Gilead's HIV portfolio, which represented over Y% of the company's total revenues during that period.

Forecasting Future Revenues

Projections indicate a gradual decline in EVOTAZ revenues over the next five years, driven by:

• Patent expirations and patent challenges.
• Increasing adoption of newer, more convenient regimens.
• Price erosion from generics, especially in developing countries.
• The growth of long-acting injectable therapies reducing oral pill demand.

Analysts estimate a compounded annual decline rate (CAGR) of approximately Z% in EVOTAZ revenues through 2028, aligning with patent timelines and market trends [5].

Potential Revenue Stabilizers

Gilead’s focus on lifecycle management — including new formulations, fixed-dose combinations with longer durability, and strategic licensing deals — aims to offset revenue decline. Moreover, context-specific demand in regions with limited access to generics sustains residual revenue streams.

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Strategic Implications and Market Opportunities

Pipeline and Innovation

Gilead has advanced investigational drugs—such as long-acting cabotegravir injections—that could revolutionize HIV treatment by reducing pill burden and improving adherence. These innovations threaten EVOTAZ’s market position but also open avenues for combined or successor products.

Partnerships and Licensing

Strategic partnerships aim to expand access and mitigate revenue losses. Licensing agreements in low-income regions facilitate market penetration of generics, suppressing EVOTAZ’s market share but aligning with broader public health goals.

Market Diversification and Vertical Integration

Expanding research into different HIV regimens—such as dual or multipurpose formulations—can diversify Gilead's portfolio. Investment in digital health and adherence programs further optimizes market engagement.

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Regulatory and External Influence

Government policies promoting biosimilars and generics, as well as changes in patent laws, considerably influence EVOTAZ’s financial prospects. Regulatory accelerations or barriers directly impact the product’s lifecycle and revenue trajectory.

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Key Takeaways

• Market demand for EVOTAZ remains steady in certain segments, especially in regions with limited access to newer therapies and where generic options are less prevalent.
• The shift toward INSTI-based regimens and long-acting injectables poses significant competitive threats, likely to accelerate EVOTAZ’s revenue decline.
• Patent expirations and generic competition will reduce prices and market share over the next 3–5 years, impacting profitability.
• Gilead’s lifecycle management strategies, partnerships, and pipeline developments are critical to maintaining financial stability for EVOTAZ.
• External factors such as regulatory policies and public health initiatives will shape the product’s long-term economic viability.

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FAQs

Q1. What is the primary competitor to EVOTAZ in the HIV treatment market?
A: The primary competitors are newer integrase inhibitor-based regimens such as Biktarvy and Triumeq, which offer simplified dosing and improved tolerability.

Q2. How will patent expirations impact EVOTAZ's revenue?
A: Patent expirations, expected around 2030–2032, will enable generic manufacturers to enter markets, driving prices down and reducing Gilead’s revenue share.

Q3. Are there upcoming formulations or versions of EVOTAZ?
A: As of now, Gilead has not announced new formulations of EVOTAZ, focusing instead on pipeline innovations, including long-acting injectables.

Q4. How does the global HIV/AIDS burden affect EVOTAZ's market potential?
A: Continued high prevalence sustains demand, especially in developing regions, although market competition and generics influence pricing and sales.

Q5. What strategic measures can Gilead adopt to extend EVOTAZ's market life?
A: Gilead can develop fixed-dose combinations with longer durability, pursue licensing agreements, expand into underserved markets, and innovate in adherence solutions.

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Sources

[1] UNAIDS. (2021). Global HIV & AIDS statistics — 2021 fact sheet.
[2] WHO. (2022). HIV/AIDS treatment guidelines.
[3] Gilead Sciences. (2022). Annual report and pipeline overview.
[4] MarketWatch. (2022). HIV drug market analysis.
[5] Bloomberg Intelligence. (2022). Pharmaceutical revenue forecasts.

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This comprehensive analysis highlights EVOTAZ’s nuanced market positioning, competitive pressures, and financial outlook, essential for stakeholders aiming to navigate the evolving landscape of HIV therapeutics.