REYATAZ Drug Patent Profile

When do Reyataz patents expire, and what generic alternatives are available?

Reyataz is a drug marketed by Bristol Myers Squibb and is included in two NDAs.

The generic ingredient in REYATAZ is atazanavir sulfate. There are twenty-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the atazanavir sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Reyataz

A generic version of REYATAZ was approved as atazanavir sulfate by TEVA PHARMS USA on April 22^nd, 2014.

Summary for REYATAZ

US Patents:	0
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REYATAZ

Paragraph IV (Patent) Challenges for REYATAZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REYATAZ	Capsules	atazanavir sulfate	100 mg and 150 mg	021567	1	2010-03-19
REYATAZ	Capsules	atazanavir sulfate	200 mg	021567	1	2010-02-16
REYATAZ	Capsules	atazanavir sulfate	300 mg	021567	1	2009-07-20

US Patents and Regulatory Information for REYATAZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-001	Jun 20, 2003		DISCN	Yes	No
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-004	Oct 16, 2006	AB	RX	Yes	Yes
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-002	Jun 20, 2003		DISCN	Yes	No
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-003	Jun 20, 2003	AB	RX	Yes	No

International Patents for REYATAZ

See the table below for patents covering REYATAZ around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	100559283
Slovakia	10622000	BISULFÁTOVÁ SOĽ HIV PROTEÁZOVÉHO INHIBÍTORA (BISULFATE SALT OF HIV PROTEASE INHIBITOR)
Hungary	224125	Vírusellenes hatású heterociklusos azahexánszármazékok, valamint ezeket tartalmazó gyógyászati készítmények (ANTIVIRALLY ACTIVE HETEROCYCLIC AZAHEXANE DERIVATIVES)
Malaysia	114838	BISULFATE SALTS OF HIV PROTEASE INHIBITOR

Supplementary Protection Certificates for REYATAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	60/2016	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715
2487163	381 2-2017	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/ATAZANAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1025 20150715
2487163	93353	Luxembourg		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE SULFATE D'ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025
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

REYATAZ Market Analysis and Financial Projection

Last updated: February 11, 2026

What is the current market position of REYATAZ?

REYATAZ (atazanavir sulfate) is an antiretroviral drug developed by Johnson & Johnson. Approved by the U.S. FDA in 2003, it is indicated for the treatment of HIV-1 infections in combination with other antiretroviral agents. Its patent expired in the United States in 2019, with generic versions entering the market subsequently. The drug’s global sales peaked around USD 600 million in 2011 but have declined over recent years due to generic competition and evolving treatment guidelines. It remains listed as an important option within specific HIV treatment regimens, especially where resistance or tolerability issues limit alternatives.

What are the key market fundamentals and competitive landscape?

Market size and trends: The global HIV drug market was valued at approximately USD 28 billion in 2022. While first-line therapies like Biktarvy and Truvada dominate sales, the niche for older protease inhibitors such as atazanavir persists in salvage therapy and for meeting specific resistance profiles.

Patent and exclusivity status: Johnson & Johnson’s patent for REYATAZ expired in the U.S. in 2019. Several generic manufacturers have launched atazanavir products, increasing price competition. Existing patents or exclusivities in other jurisdictions vary and influence regional pricing.

Pricing and reimbursement: Brand-name REYATAZ initially commanded higher prices, but with generic entry, prices have dropped significantly—estimated reductions of over 70% in key markets. Reimbursement policies favor generics, reducing profit margins for originators.

Regulatory and clinical considerations: REYATAZ is often used in combination therapies, with resistance profiles favoring its use in salvage therapy settings. Resistance development remains a concern, and newer agents with improved tolerability have reduce reliance on older protease inhibitors.

Pipeline and development prospects: No recent or ongoing development programs for REYATAZ specifically; interest has shifted toward next-generation antiretrovirals with improved safety and efficacy.

What are the financial implications for investment?

Revenue trajectory: Post-2019 patent expiry, sales declined from peak levels. Generic competition silenced profit margins, with current global sales estimated between USD 50 million and 100 million annually, primarily from emerging markets and salvage therapy niches.

Profitability outlook: As a mature product with declining sales and limited pipeline activity, REYATAZ offers limited growth prospects. Investments should focus on indications where it retains clinical relevance rather than new development.

Risks: Market erosion from generics is ongoing. The emergence of newer agents with better tolerability and simpler dosing further diminishes its market share. Regulatory challenges may arise in regions with patent disputes or strategic pricing restrictions.

Opportunities: Positioning in off-label combinations or niche markets may sustain minimal revenues. Alternatively, licensing or divestment options could be considered for firms seeking to exit low-margin mature drugs.

How does REYATAZ compare with current competitors?

Drug	Class	Indication	Year Approved	Peak Sales	Notes
Biktarvy	NRTI/NTI/INSTI	HIV-1	2018	USD 8.2 billion (2022)	Dominates new therapies
Truvada	NRTI	HIV pre-exposure prophylaxis & treatment	2004	USD 3 billion (2019)	Generic competition active
Atazanavir (generic)	Protease inhibitor	HIV	2003	USD 50-100 million	Niche salvage therapy

No direct new formulation or significant differentiation keeps REYATAZ in a declining niche. Its role remains limited in salvage therapy where resistance profiles warrant its use.

What are the strategic considerations for stakeholders?

For investors: Limited growth potential due to patent expiry and generic competition. Focus on the residual niche market or consider divestment.

For developers: R&D pipelines favor next-generation antiretrovirals with improved safety and dosing profiles. Investing in drugs targeting resistant HIV strains or curative approaches offers higher long-term value.

For pharmaceutical firms: Opportunities in licensing or forming partnerships in emerging markets with ongoing demand for older antiretroviral agents.

Regulatory outlook: Patent disputes and regional approvals influence market access and revenue stability.

Key takeaways

• REYATAZ's revenue has declined significantly since patent expiry in 2019 due to generic competition.
• The drug remains relevant in salvage therapy but faces obsolescence from newer agents.
• The market outlook favors companies with pipeline assets more aligned with current HIV treatment standards.
• Generic pricing dynamics pressure profit margins for the branded product.
• Strategic focus should shift from R&D for REYATAZ toward next-generation HIV therapeutics.

FAQs

1. Will REYATAZ regain market share?
Unlikely. Its role is limited to salvage therapy, and newer agents with better safety profiles dominate first-line treatments.

2. Are there any development efforts to improve REYATAZ?
No known efforts exist; the focus has shifted toward novel drugs with improved efficacy and tolerability.

3. How do generic versions impact the market?
They reduce prices and sales volume for the original brand, eroding revenue and profitability.

4. What regions still see significant use of atazanavir?
Emerging markets with limited access to newer drugs and where generic versions are prevalent.

5. What are the main risks in investing in REYATAZ?
Market erosion from generics, limited pipeline activity, and competition from advanced therapies threaten future revenues.

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References

1. IQVIA. "Global HIV Market Report," 2022.
2. FDA. "Reyataz (atazanavir sulfate) NDA 21-446," 2003.
3. Johnson & Johnson Annual Reports, 2019–2022.
4. Evaluate Pharma. "HIV Drugs Sales & Pipeline Analysis," 2022.