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 six patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for ATAZANAVIR SULFATE; COBICISTAT

International Patents:	306
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

Constraining patent/regulatory exclusivity:

10,039,718

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	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 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	5,849,911*PED
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015	6,087,383*PED

International Patents for ATAZANAVIR SULFATE; COBICISTAT

Country	Patent Number	Title	Estimated Expiration
Montenegro	02680
Taiwan	I496778
Luxembourg	92864
European Patent Office	2393485
Lithuania	C3150586
Denmark	2049506

Supplementary Protection Certificates for ATAZANAVIR SULFATE; COBICISTAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487162	17C1002	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE ET LE DARUNAVIR OU SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; REGISTRATION NO/DATE: EU/1/14/967 20141121
2487163	122016000120	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCHES AKZEPTABLES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1025 20150713
3150586	122020000022	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND EMTRICITABIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170921
2487166	17C1001	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET TENOFOVIR ALAFENAMIDE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
2049506	262 5024-2015	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM; REGISTRATION NO/DATE: EU/1/13/830 20130527
2049506	C20150046 00250	Estonia		PRODUCT NAME: KOBITSISTAAT;REG NO/DATE: EU/1/13/830/001-002 27.05.2013

ATAZANAVIR SULFATE; COBICISTAT Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for ATAZANAVIR SULFATE and COBICISTAT?

The combination of ATAZANAVIR SULFATE and COBICISTAT is positioned within the HIV treatment landscape. The drugs target HIV-1 protease inhibition and coreceptor CCR5 antagonism, respectively, which are vital for suppressing viral replication. The drug duo’s market prospects depend on several factors: frequency of HIV diagnoses, existing treatment options, competitive landscape, and regulatory approval status.

HIV Treatment Landscape

The global HIV treatment market projected a valuation of approximately USD 27.5 billion in 2021. The demand for effective antiretroviral therapy (ART) remains high due to the persistent prevalence of HIV infections. Estimated annual new infections worldwide numbered 1.5 million in 2021, with populations in North America, Europe, and regions of Africa demonstrating high treatment uptake.

Therapeutic Positioning

ATAZANAVIR SULFATE, marketed as a protease inhibitor, is a well-established component of ART regimens. COBICISTAT, a pharmacokinetic booster, enhances the efficacy of other ART agents including protease inhibitors like ATazanavir. This combination is designed to improve potency and dosing convenience, potentially increasing adherence.

Market Drivers

• Rising HIV prevalence: Continual new infections sustain demand for ART.
• Adherence challenges: Fixed-dose combinations like ATAZANAVIR and COBICISTAT reduce pill burden, favoring compliance.
• Patent expirations: Though ATazanavir's patent expired globally in 2022, formulations with COBICISTAT may be protected by new patents or exclusivities.
• Treatment guidelines: Updated HIV management protocols favor integrative regimens that simplify dosing and minimize side effects.

Competitive Landscape

Key competitors include Dolutegravir-based regimens (e.g., Trivicay, Tivicay), Bictegravir combinations (e.g., Biktarvy), and emerging entry of novel agents. Existing providers leverage established efficacy and safety profiles, challenging newer combination therapies.

Regulatory Considerations

Regulatory agencies approve fixed-dose combinations based on non-inferiority to existing regimens, emphasizing safety, tolerability, and adherence benefits. Approval timelines influence market entry and sales trajectories.

What Is the Financial Trajectory for the Drugs?

The financial outlook bases on current sales, patent status, and pipeline activity.

Revenue Estimates

• Historical sales: Gilead Science’s HIV portfolio generated USD 16.7 billion in 2021. Protease inhibitors accounted for a significant share.
• Market share projections: In low- and middle-income countries, generic versions reduce prices, constraining revenue growth. In high-income countries, branded formulations retain premium pricing, supporting sustained margins.

Pricing Dynamics

• Pricing in U.S.: The average wholesale price for protease inhibitors like ATazanavir is around USD 1,500–2,000 per month per patient. COBICISTAT-based formulations may command slightly higher prices due to convenience and efficacy.
• Cost-effectiveness: Regimens providing superior adherence and fewer side effects justify higher pricing levels.

Patent and Exclusivity Effects

• Patents for ATazanavir expired in 2022, leading to increased generic competition within the next 12–24 months.
• COBICISTAT, as a new entity, could be protected by prescribing and formulation patents extending exclusivity until 2030, depending on jurisdiction.

Pipeline and Market Expansion

• Approval in pediatric and special populations could expand market size.
• New combinations, especially with integrase inhibitors, could threaten or complement ATAZANAVIR + COBICISTAT sales.

Geographical Variations

• North America: USD 9–10 billion market; high penetration of branded drugs.
• Africa and Asia: Market driven by generics, with price-sensitive pricing models.

How Do Regulatory and Policy Changes Affect Market and Financial Trajectories?

• Regulatory bodies like the FDA and EMA evaluate fixed-dose combination efficacy and safety.
• WHO treatment guidelines influence adoption rates; updates can accelerate prescribing.
• Patent litigations and compulsory licensing impact revenue streams.
• Local pricing regulations and reimbursement policies can limit or enable market expansion.

Key Challenges and Opportunities

Challenges

• Patent expirations consolidating generic competition.
• Growing prevalence of integrase inhibitor-based regimens as first-line therapy.
• Cost sensitivity in emerging markets.

Opportunities

• Positioning as an alternative in cases of resistance or intolerability.
• Advancing formulations with improved dosing schedules.
• Expanding indications to other viral infections.

Conclusion

The market for ATAZANAVIR SULFATE and COBICISTAT is constrained by patent expirations but benefits from ongoing demand driven by global HIV prevalence. Financial trajectories depend on patent protection, competitive dynamics, and regulatory policies. The combination faces intense competition from newer integrase inhibitor-based therapies, yet opportunities remain in niche populations and adherence-enhancing formulations.

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Key Takeaways

• The global HIV treatment market remains sizable, with ongoing demand for protease inhibitor-based regimens.
• The combination may see revenue stabilization or decline post-patent expiry due to generic competition.
• Pricing strategies and regulatory approvals heavily influence financial success.
• Competing therapies, especially integrase inhibitors, challenge market share.
• Pipeline and formulation innovation can provide differentiation and sustain market presence.

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FAQs

1. What is the patent status of ATAZANAVIR SULFATE?
Patents for generic formulations expired in 2022, opening the market to biosimilars and generics, though new formulations with COBICISTAT may still have patent protection.

2. How does COBICISTAT improve HIV treatment regimens?
It boosts plasma concentrations of other protease inhibitors, allowing lower doses with fewer side effects, and improves adherence by reducing pill burden.

3. Are there major regulatory hurdles for FDA approval?
Fixed-dose combinations must demonstrate bioequivalence, safety, and efficacy. Regulatory agencies have approved similar combinations, but each new formulation undergoes rigorous review.

4. How does the emergence of integrase inhibitors affect this drug combination’s market?
It limits market share as physicians prefer once-daily, high-efficacy regimens like Dolutegravir-based therapies, especially as first-line treatments.

5. What strategies could extend the market life of ATAZANAVIR + COBICISTAT?
Developing pediatric formulations, expanding indications, improving adherence profiles, and securing new patents or exclusivities are key strategies.

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References

[1] Global HIV market size, forecasts, and competitive landscape data, Market Research Future.
[2] Gilead Sciences Annual Report 2021.
[3] World Health Organization Global HIV Update 2022.
[4] U.S. Patent and Trademark Office, Patent expiration dates for Atazanavir.
[5] FDA Drug Approval Database.