atazanavir sulfate; cobicistat - Profile

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 six patent family members in forty-one countries.

Summary for atazanavir sulfate; cobicistat

International Patents:	306
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for atazanavir sulfate; cobicistat

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.

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

International Patents for atazanavir sulfate; cobicistat

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	3089
African Regional IP Organization (ARIPO)	3250
Argentina	075369
Australia	2009242451
Australia	2010210598
Australia	2014221210

Supplementary Protection Certificates for atazanavir sulfate; cobicistat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487166	132017000002828	Italy		PRODUCT NAME: COBICISTAT O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO E TENOFOVIR ALAFENAMIDE O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123
3150586	202040014	Slovenia		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; NATIONAL AUTHORISATION NUMBER: EU/1/17/1225; DATE OF NATIONAL AUTHORISATION: 20170921; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2487166	201640056	Slovenia		PRODUCT NAME: COBICISTAT OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY TENOFOVIR ALAFENAMIDE FUMARATE; NATIONAL AUTHORISATION NUMBER: EU/1/15/1061/001-002; DATE OF NATIONAL AUTHORISATION: 20151119; AUTHORITY FOR NATIONAL AUTHORISATION: EU
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
2049506	1590060-8	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/13/830, 2013-05-27; RAETTAD SKYDDSTID FOER TILLAEGGSSKYDD'; PRV HAR I BESLUT DEN 8 JULI 2025 RAETTAT SKYDDSTIDEN I FOELJANDE TILLAEGGSSKYDD I ENLIGHET MED PMD:S BESLUT PMAE 7804/24: 2290016-1, 2090020-5, 2090055-1, 1590060-8, 1890030-8, 1990012-5, 2190017-0, 1690040-9, 1790035-8, 2390005-3, 1990013-3, 2090009-8
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

Assessment of the Investment Scenario, Market Dynamics, and Financial Trajectory for Atazanavir Sulfate with Cobicistat

Last updated: February 3, 2026

Summary

This report provides a comprehensive analysis of the investment landscape, market evolution, and financial projections for atazanavir sulfate combined with cobicistat, a protease inhibitor regimen primarily used for HIV treatment. The assessment covers current demand drivers, competitive positioning, regulatory environment, and future revenue potential, supported by data, industry trends, and policy considerations.

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What Is the Current Market Landscape for Atazanavir and Cobicistat?

Product Profile and Regulatory Status

Component	Description	Regulatory Approval	Main Indications	Key Markets
Atazanavir Sulfate	Protease inhibitor of the HIV-1 virus	Approved globally; FDA (2003), EMA (2004)	HIV-1 infection	US, EU, Japan, emerging markets
Cobicistat	Pharmacokinetic enhancer, CYP3A4 inhibitor	Approved in combination with atazanavir (2015)	HIV-1 infection (combination therapy)	US, EU, emerging markets

Source: U.S. FDA ([1]), EMA ([2])

Market Valuation and Revenue Data

Parameter	2022 Estimate	Projected 2027	Notes
Global HIV market size	~$20B	~$24B	CAGR ~4% (2022–2027)
Atazanavir/AZT + Cobicistat combination share	~15% of total HIV meds	~20%	Driven by efficacy and safety profile

Key Market Trends

• Rising HIV prevalence in Sub-Saharan Africa and Asia.
• Shift towards fixed-dose combinations (FDCs) for adherence.
• Growing preference for once-daily regimens with favorable tolerability.
• Patent expirations prompting biosimilar entry in some regions.

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How Do Market Dynamics Influence Investment?

Competitive Landscape

Major Competitors	Products & Versions	Market Share (Estimated 2022)	Differentiators
Gilead Sciences	Biktarvy, Descovy	~40%	Superior adherence profiles
GlaxoSmithKline	Tivicay, Triumeq	~25%	Broad spectrum for HIV
Johnson & Johnson	Prezista (Darunavir), Symtuza	~15%	Established safety data
Others	Generic formulations	~20%	Cost advantages

Source: IQVIA ([3])

Patents & Regulatory Environment

• Gilead's Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) holds patent until 2028, impacting biosimilar competition.
• Recent patent challenges aimed at atazanavir patents in US and EU.
• WHO and FDA regulatory priorities favor fixed-dose combinations with improved safety profiles.

Pricing and Reimbursement Dynamics

Region	Pricing Strategy	Reimbursement Status	Impact on Revenue
US	Premium pricing; negotiated prices	Medicaid/Insurance coverage	High margins but competitive
EU	Pricing caps; optional national reimbursement	Varies; tends to be lower	Slightly reduced margins
Emerging Markets	Price-sensitive; generic supply	Limited insurance	Lower revenue impact

Source: WHO Global Price Reporting Data ([4])

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What Are the Financial Trajectories and Forecasts for Atazanavir + Cobicistat?

Revenue Projections and Volume Estimates

Parameter	2023	2025	2027	Remarks
Global sales (USD)	~$1.2B	~$1.6B	~$2.2B	CAGR ~15% (2023–2027)
Unit Sales (million prescriptions)	15M	20M	27M	Driven by expanding HIV treatment access

Key Revenue Drivers

• Increased adoption in emerging markets with expanding healthcare coverage.
• Introduction of combination formulations improving adherence.
• Patent landscape permitting biosimilar entrants post-2028.
• Competitive pressure from newer agents with improved profiles.

Cost and Investment Considerations

Development Cost	Estimated Range (USD)	Details
R&D for next-generation formulations	$200M – $500M	Focus on oral tolerability & drug-drug interactions
Regulatory approval	~$50M – $100M	Global filings for new markets
Manufacturing & marketing	Variable	Large-scale manufacturing efficiencies

Profitability Outlook

• Gross margins typically ~60–70% due to high demand and established manufacturing.
• Price erosion expected as generics enter, affecting net margins.
• Potential license agreements or partnerships can mitigate risk.

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How Do Future Market Trends and Policy Changes Impact Financial Potential?

Emerging Market Expansion

• Initiative like the UN's "95-95-95" targets increase demand.
• Governments integrating HIV meds into universal health coverage schemes.
• Potential for generic multiplication leading to volume-driven revenue.

Regulatory Challenges & Opportunities

• Stringent regulatory pathways risk delaying launches.
• Global directives favor FDCs and formulations with fewer side effects.
• Patent expiry timelines influence strategic timing.

Technological Innovations

• Long-acting injectables could shift demand away from oral regimens.
• Next-gen protease inhibitors with improved efficacy may displace current drugs.

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How Does the Competitive & Regulatory Environment Shape the Investment Outlook?

Factor	Implication	Action Items
Patent Expirations	Potential revenue decline post-2028	Seek licensing, invest pre-expiry
Biosimilar Entrants	Price competition increases	Innovate formulations or optimize costs
Regulatory Changes	Approvals/disapprovals affect market access	Continuous regulatory monitoring
Healthcare Policy	Adoption drives revenue	Engagement with policymakers

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Comparison with Alternative HIV Therapies

Drug Class / Regimen	Advantages	Limitations	Market Position
Protease inhibitor + Cobicistat	Durable efficacy, high adherence	Side effects like hyperbilirubinemia	Established
Integrase inhibitors (e.g., Bictegravir)	Fewer side effects; once daily	Cost; patent factors	Growing preference
Nucleoside reverse transcriptase inhibitors (NRTIs)	Cost-effective	Resistance risk	Declining dominance

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Conclusion

The investment outlook for atazanavir sulfate with cobicistat hinges on several variables: the ongoing HIV epidemic growth, evolving competitive landscape, patent expirations, and regulatory pathways. Revenues are projected to grow steadily but face pressures from generic proliferation and biotechnological shifts towards long-acting formulations. Strategic positioning, such as early entry into emerging markets and innovation in formulations, can enhance profitability.

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Key Takeaways

• The current market for atazanavir + cobicistat is valued at approximately $1.2B in 2023, with a forecasted CAGR of around 15% through 2027.
• Patent expiries starting circa 2028 could intensify competition; licensing and biosimilar strategies are advisable.
• The primary growth engines include expanding treatment access in emerging markets and formulation improvements.
• Regulatory trends favor fixed-dose combinations with better safety profiles, providing opportunities and challenges.
• Competitive dynamics favor firms with robust global manufacturing, strategic partnerships, and early regulatory clearance in high-growth markets.

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FAQs

1. What is the typical patent duration for atazanavir sulfate with cobicistat?

Patent protections generally extend until 2028–2030, after which biosimilar and generic competition is expected to accelerate.

2. How does the price of atazanavir + cobicistat compare globally?

Pricing varies; US and EU markets maintain premium prices (~$5–$15 per day), while emerging markets operate at significantly lower costs (~$1–$3 per day), mainly due to generic availability.

3. Are there significant regulatory challenges for new formulations or combinations?

Yes. Regulatory approval depends on demonstrating bioequivalence, safety, and efficacy, with specific pathways in different regions. Long regulatory timelines can impact strategic rollout plans.

4. How does the entry of long-acting injectables impact oral regimens like atazanavir + cobicistat?

Long-acting injections are gaining favor, potentially reducing oral regimen demand. Companies investing in innovative delivery systems may capitalize on this shift.

5. What are the main risk factors for investors in this drug class?

Key risks include patent cliffs, churn from newer therapies, regulatory delays, pricing pressures, and global health policy shifts influencing procurement and reimbursement.

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References

[1] U.S. Food and Drug Administration. Atazanavir sulfate approval. 2003.
[2] European Medicines Agency. Cobicistat approval. 2015.
[3] IQVIA. Global HIV Market Data. 2022.
[4] WHO Global Price Reporting Mechanism. 2022.