ATAZANAVIR SULFATE; COBICISTAT - Generic Drug Details

What are the generic drug sources for atazanavir sulfate; cobicistat and what is the scope of patent protection?

Atazanavir sulfate; cobicistat is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Atazanavir sulfate; cobicistat has three hundred and five patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for ATAZANAVIR SULFATE; COBICISTAT

International Patents:	305
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATAZANAVIR SULFATE; COBICISTAT
DailyMed Link:	ATAZANAVIR SULFATE; COBICISTAT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ATAZANAVIR SULFATE; COBICISTAT

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.

Pharmacology for ATAZANAVIR SULFATE; COBICISTAT

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

Anatomical Therapeutic Chemical (ATC) Classes for ATAZANAVIR SULFATE; COBICISTAT

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

V03AX	Other therapeutic products
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for ATAZANAVIR SULFATE; COBICISTAT

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 ATAZANAVIR SULFATE; COBICISTAT

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			Y
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015		RX	Yes	Yes			Y	Y

Expired US Patents for ATAZANAVIR SULFATE; COBICISTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015

International Patents for ATAZANAVIR SULFATE; COBICISTAT

Country	Patent Number	Title	Estimated Expiration
Portugal	3150586
Cyprus	1118292
Hong Kong	1164737	包括埃替拉韋， ，恩曲他濱和替諾福韋的雙層片劑 (BILAYER TABLETS COMPRISING ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR COBICISTAT)
Ukraine	103224	ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ;ТАБЛЕТКИ ДЛЯ КОМБІНОВАНОЇ ТЕРАПІЇ (Normal;heading 1;heading 2;heading 3;TABLETS FOR COMBINATION THERAPY)
Lithuania	2487162
Croatia	P20161476

Supplementary Protection Certificates for ATAZANAVIR SULFATE; COBICISTAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487162	132017000002735	Italy		PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO E DARUNAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO(REZOLSTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/967, 20141121
2049506	15C0078	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2487166	122016000104	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND TENOFOVIRALAFENAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1061 20151119
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
2487163	2016C/066	Belgium		PRODUCT NAME: COBICISTAT ET ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025 20150715
3150586	301045	Netherlands		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER DARUNAVIRETHANOLAAT, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1225 20170925

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ATAZANAVIR SULFATE; COBICISTAT

Last updated: July 27, 2025

Introduction

The combination of Atazanavir Sulfate and Cobicistat represents a pivotal therapeutic advancement in the management of HIV/AIDS. Atazanavir, a protease inhibitor, coupled with Cobicistat, a pharmacokinetic enhancer, has carved a significant niche in antiretroviral therapy (ART). This article explores the evolving market landscape, financial prospects, competitive positioning, and future outlook of this drug duo, providing stakeholders with an authoritative analysis essential for strategic decision-making.

Market Landscape and Demand Drivers

Global HIV/AIDS Burden

An estimated 38 million individuals worldwide live with HIV/AIDS, with approximately 1.5 million new infections annually [1]. The growing prevalence reinforces sustained demand for effective ART regimens. The introduction of fixed-dose combinations, like Atazanavir Sulfate and Cobicistat, simplifies treatment protocols, improving patient adherence and outcomes.

Treatment Guidelines and Adoption Trends

Leading guidelines, including those from the WHO and CDC, endorse once-daily, single-tablet regimens incorporating protease inhibitors boosted with Cobicistat for specific patient populations, especially treatment-experienced individuals [2]. The shift toward integrative, simplified ART regimens propels the adoption of combinations involving Atazanavir and Cobicistat.

Market Expansion: Emerging Economies

Developing nations, with expanding healthcare infrastructure and rising awareness, contribute substantially to global demand. Government initiatives and subsidies further facilitate access, paving the way for broader market penetration.

Competitive Landscape

The segment faces competition from integrase strand transfer inhibitors (INSTIs) like Dolutegravir and Bictegravir-based regimens, which are gaining popularity owing to favorable safety profiles [3]. Nonetheless, Atazanavir + Cobicistat remains integral for certain patient subsets, particularly those with resistance profiles or intolerance to alternative agents.

Pharmacoeconomic and Pricing Dynamics

Cost Structures

Manufacturing costs for fixed-dose combinations have declined owing to advances in formulation technology. Patent protections and exclusivity periods significantly influence pricing strategies, with branded versions commanding premium pricing during patent life.

Pricing Strategies and Reimbursement

Pricing varies across markets, heavily influenced by local healthcare policies and payer negotiations. In high-income markets like the US and EU, reimbursement frameworks tend to favor newer, branded regimens, supporting higher margins. Conversely, in low- and middle-income countries, generic proliferation and price negotiations drive down costs.

Biosimilar and Generic Competition

Patent expirations, expected within the next 5–7 years, may lower drug prices substantially through biosimilars or generics. Such competition could diminish margins for current manufacturers but also expand access.

Financial Trajectory and Market Projections

Revenue Forecasts

Forecasts predict the global antiretroviral market to reach approximately $30 billion by 2027, growing at a CAGR of 5.7% from 2022 [4]. The Atazanavir + Cobicistat segment, representing a notable share, is expected to sustain steady growth driven by the evolving treatment landscape.

Growth Catalysts

• Increasing HIV prevalence in underserved regions.
• Guideline-driven adoption of boosted protease inhibitor regimens.
• Pipeline innovations, such as fixed-dose formulations minimizing pill burden.
• Strategic partnerships between pharmaceutical companies and governments for program supply.

Risks and Challenges

• Market saturation with newer ART classes.
• Patent cliff events leading to revenue declines.
• Pricing pressures from generics and biosimilars.
• Regulatory uncertainties affecting approval timelines and market access.

Regulatory and Patent Landscape

The patent lifecycle critically influences financial trajectories. Lapses or challenges diminish market exclusivity, fostering generic entry. Currently, the primary patent covering Atazanavir Sulfate and Cobicistat is expected to expire between 2025 and 2030, after which market dynamics could pivot markedly [5].

Regulatory pathways for biosimilar approval are evolving, requiring strategic positioning to mitigate patent risks and capitalize on late-stage opportunities.

Future Outlook and Strategic Implications

The therapeutic landscape will likely witness a gradual shift toward more tolerable, simplified regimens. Nevertheless, the entrenched clinical efficacy, pharmacokinetic benefits, and supportive guidelines sustain demand for Atazanavir + Cobicistat formulations for specific patient populations.

Manufacturers investing in pipeline enhancements—such as long-acting formulations—could prolong market relevance. Strategic alliances, regional market expansion initiatives, and pricing agility will be paramount to optimize financial outcomes amid intensifying competition.

Key Takeaways

• The global demand for HIV treatments supports stable growth trajectories for Atazanavir Sulfate with Cobicistat, especially in regions with expanding healthcare access.
• While competition from newer ART classes intensifies, the existing combination maintains a crucial clinical niche, safeguarding revenue streams.
• Patent expirations within the next decade are poised to catalyze price erosion and market commodification via generics and biosimilars.
• Strategic investments in formulation advancements and regional market development can mitigate patent risks and foster sustained profitability.
• Regional payor dynamics, regulatory environments, and competitive pressures necessitate adaptive strategies for market sustainability.

FAQs

1. What are the main advantages of combining Atazanavir Sulfate with Cobicistat?
This combination offers a once-daily, fixed-dose regimen that enhances patient adherence, reduces pill burden, and improves pharmacokinetic profiles, facilitating effective viral suppression.

2. How does patent expiration affect the financial prospects of this drug combination?
Patent expiry permits generic manufacturers to enter the market, significantly reducing pricing and potentially eroding branded sales revenues. This shift necessitates strategic planning to maintain profitability through differentiation or pipeline development.

3. What competitive threats does this combination face?
Emerging therapies like INSTI-based regimens (e.g., Dolutegravir) offer comparable or superior safety profiles and simplified dosing, challenging Atazanavir + Cobicistat’s market share.

4. Is this drug combination suitable for all HIV patients?
While effective, it is primarily indicated for treatment-experienced patients or those tolerating protease inhibitors. Treatment decisions should consider resistance profiles, comorbidities, and guideline recommendations.

5. What market regions are primed for growth in this segment?
Emerging markets, including Africa and parts of Asia, exhibit increasing demand driven by expanding HIV programs and decreasing treatment costs, representing lucrative growth opportunities.

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References

[1] UNAIDS. Global HIV & AIDS statistics—2022 fact sheet.
[2] WHO Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations. 2021.
[3] Gaiha, S. et al. "The evolving landscape of HIV treatment: Focus on protease inhibitors." J Infect Dis 2022.
[4] MarketsandMarkets. Antiretroviral Market by Product, Region—Forecast 2022-2027.
[5] U.S. Patent and Trademark Office. Patent expiry timelines for Atazanavir and Cobicistat.

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This comprehensive analysis underscores the complex, dynamic nature of the Atazanavir Sulfate and Cobicistat market, emphasizing the need for agile strategic approaches to harness upcoming opportunities while mitigating inherent risks.