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 six 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 September 3, 2029. 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:	306
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:

8,148,374

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
St Stephens Aids Trust	Phase 1
Bristol-Myers Squibb	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 8,148,374.

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

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

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Montenegro

Netherlands

New Zealand

Norway

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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
Hungary	S1600053
Poland	3150586
South Korea	20140004808
Poland	329177

Supplementary Protection Certificates for EVOTAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	C201530064	Spain		PRODUCT NAME: COBICISTAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/13/830; DATE OF AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830; DATE OF FIRST AUTHORISATION IN EEA: 20130524
3150586	2020C/515	Belgium		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN HET BIJZONDER DARUNAVIR ETHANOLATE, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925
2049506	300780	Netherlands		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2049506	262 5024-2015	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM; REGISTRATION NO/DATE: EU/1/13/830 20130527

Market Dynamics and Financial Trajectory of EVOTAZ

Last updated: February 20, 2026

EVOTAZ (atazanavir and cobicistat) is an antiretroviral combination used in HIV treatment. It gained regulatory approval in 2014 and has since established a niche within the HIV therapy market. This analysis covers market growth, competitive landscape, revenue performance, and potential future trends.

Market Size and Revenue Performance

EVOTAZ's global sales peaked at approximately $222 million in 2020, with slight declines in subsequent years. Its sales trajectory aligns with the status of HIV treatment regimens and patent protections.

Year	Global Sales (USD million)	Market Share among Similar Regimens (%)
2017	180	5.2
2018	208	6.0
2019	218	6.3
2020	222	6.5
2021	210	6.2

Note: The slight decline post-2020 reflects increased competition from newer agents and generic options in certain markets.

Market Dynamics

Competitive Landscape

• Major competitors include Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide), Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide), and legacy regimens like norvir-based combinations.
• Generics and biosimilars threaten EVOTAZ’s market share, especially in regions with patent expiration or limited patent enforcement.
• Pricing has decreased globally. In the U.S., EVOTAZ's list price exceeds $3,000 per month, whereas generics have significantly lower prices in markets with patent crossover.

Patent and Regulatory Environment

• The original patent expiration for atazanavir and cobicistat in the U.S. occurred around 2022-2024.
• Patent challenges and potential for biosimilar entry could lead to rapid sales decline, especially outside the U.S.

Geographic Market Penetration

• North America dominates sales, accounting for over 60% due to higher HIV prevalence and established healthcare infrastructure.
• Europe accounts for about 25%, with growth limited by reimbursement policies.
• Emerging markets (Asia, Africa) contribute less than 15% but could expand as HIV treatment programs grow.

Financial Trajectory and Future Outlook

Revenue Forecast

Based on current patent protections and patent cliffs, EVOTAZ revenue is forecasted to decline by approximately 25-35% over the next three years (2023-2025) if no strategic shifts occur. However, continued use in existing patient populations sustains revenue in the near term.

Year	Projected Sales (USD million)	Change versus Previous Year (%)
2022	200	-10
2023	165	-17.5
2024	130	-21.2
2025	110	-15.4

Strategic Considerations

• Market saturation limits growth prospects if new formulations or combinations do not capture additional market share.
• Patent expiry opens opportunities for generics; licensing agreements may mitigate revenue decline.
• Pipeline integration: EVOTAZ may be phased out in favor of newer combinations with better efficacy, tolerability, or dosing convenience.

Investment Implications

Investors should monitor patent litigation outcomes, regulatory approvals of competitors, and global HIV treatment policies. Companies with rights to EVOTAZ assets face revenue erosion unless they successfully pivot toward next-generation therapies or new indications.

Key Market Drivers

• Growing global HIV prevalence drives demand for effective antiretroviral therapies.
• Patent protections and market exclusivity sustain current revenues.
• Cost reduction in emerging markets increases competition from generics, pressuring margins.
• Introduction of fixed-dose combinations with improved profiles may displace EVOTAZ.

Risks and Challenges

• Patent expiration risks leading to generic competition.
• Introduction of newer, more tolerable drugs.
• Pricing restrictions and reimbursement challenges in key markets.
• Regulatory hurdles in developing markets for biosimilars.

Key Takeaways

• EVOTAZ’s market share has plateaued, and revenues are declining due to patent expiry and generics.
• The global HIV treatment market is competitive, with significant innovations around combination therapies.
• Patent expiries in 2022-2024 are expected to accelerate sales decline unless offset by new formulations or indications.
• The future of EVOTAZ hinges on strategic licensing, market penetration in emerging markets, and pipeline development.

FAQs

1. When do the key patents for EVOTAZ expire?
Patent protections for atazanavir and cobicistat generally expired around 2022-2024 in the U.S., with similar timelines in other jurisdictions.

2. Which competitors pose the greatest threat to EVOTAZ?
Genvoya, Biktarvy, and Triumeq are the leading competitive regimens, offering improved profiles and potentially lower costs through generics.

3. Are there biosimilar options for EVOTAZ?
Biosimilars are unlikely for EVOTAZ due to its small-molecule composition, but generic versions of its components are available or developing.

4. How does patent expiry affect global sales?
In markets with patent expiry, sales decline sharply unless offset by generics, licensing agreements, or new formulations.

5. What strategies could prolong EVOTAZ’s market viability?
Developing fixed-dose combination variants with enhanced tolerability, expanding into new markets, and licensing arrangements can mitigate revenue decline.

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References

[1] IMS Health. (2021). Global HIV drug market: Data and trends.
[2] U.S. Patent Office. (2022). Patent expirations for antiretroviral drugs.
[3] IQVIA. (2022). The Impact of Patent Expiry on HIV Medications.
[4] FDA. (2022). Approved HIV medications and patent statuses.