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. Six 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	67
Patent Applications:	5,191
Drug Prices:	Drug price information for REYATAZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REYATAZ
What excipients (inactive ingredients) are in REYATAZ?	REYATAZ excipients list
DailyMed Link:	REYATAZ at DailyMed

See drug prices for REYATAZ

Recent Clinical Trials for REYATAZ

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Acrotech Biopharma LLC	Phase 1
Axis Clinicals Limited	Phase 1
University of Turin, Italy	Phase 3

See all REYATAZ clinical trials

Pharmacology for REYATAZ

Drug Class	Protease Inhibitor
Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors UDP Glucuronosyltransferases Inhibitors UGT1A1 Inhibitors

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

Expired US Patents for REYATAZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-004	Oct 16, 2006
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	POWDER;ORAL	206352-001	Jun 2, 2014
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-001	Jun 20, 2003

EU/EMA Drug Approvals for REYATAZ

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Reyataz	atazanavir sulfate	EMEA/H/C/000494Reyataz capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations).The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4.2).Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors ( 4 PI mutations). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).	Authorised	no	no	no	2004-03-01

International Patents for REYATAZ

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

Country	Patent Number	Title	Estimated Expiration
Germany	69806067
Hungary	9901612
Ukraine	59432	БИСУЛЬФАТ ИНГИБИТОРА ВИЧ-ПРОТЕАЗЫ;МОНОСУЛЬФАТ АЗАПЕПТИДНОГО ПОХІДНОГО ТА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ НА ЙОГО ОСНОВІ (HIV protease inhibitor bisulfate)

Supplementary Protection Certificates for REYATAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0900210	CA 2005 00037	Denmark
2487163	SPC/GB17/010	United Kingdom		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REGISTERED: UK EU/1/15/1025/001 20150715; UK EU/1/15/1025/002 20150715
0900210	05C0030	France		PRODUCT NAME: ATAZANAVIR ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/03/267/001 DU 20040302; REGISTRATION NO/DATE AT EEC: EU/1/03/237/001 DU 20040302

Market Dynamics and Financial Trajectory for REYATAZ (Atazanavir)

Last updated: December 17, 2025

Executive Summary

Reyataz (atazanavir) is an antiretroviral drug developed and marketed by Bristol-Myers Squibb (BMS) for the treatment of HIV-1 infection. Since its FDA approval in 2003, Reyataz has retained a significant position within combination antiretroviral therapy (cART). This analysis provides a comprehensive market dynamics overview and forecasts its financial trajectory through 2028, considering factors such as competitive landscape, patent status, regulatory developments, and epidemiological trends.

Key highlights include:

• Market Size & Growth: The global HIV therapeutics market is projected to reach approximately $30 billion by 2027 with a CAGR of 3.5%. Reyataz currently accounts for roughly 10-12% of the market share within protease inhibitors (PIs).
• Patent & Patent Expiry Risks: Patent expiration for Reyataz is expected in 2024 in the U.S., which could significantly impact revenues due to generic competition.
• Competitive Landscape: Dominated by second-generation PIs (e.g., Darunavir), integrase inhibitors (e.g., Dolutegravir), and emerging long-acting formulations.
• Regulatory & Developmental Trends: Ongoing interest in fixed-dose combinations and long-acting injectables. Regulatory approvals in emerging markets are expanding revenue streams.
• Financial Outlook: Revenues from Reyataz are projected to decline post-2024 but remain relevant through next-generation formulations and combination therapies.

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What Are the Current Market Dynamics for Reyataz?

Historical and Current Market Position

Reyataz was among the first once-daily PIs, approved by the FDA in 2003, and maintained a significant share of the HIV therapeutic market, especially in the early 2000s. Its unique pharmacokinetic profile—favorable for once-daily dosing without ritonavir boosting—made it a preferred option.

• Market Share (2022): Estimated 10-12% within PI class, with total HIV drug sales of approximately $20 billion globally.
• Pricing: In the U.S., retail prices for Reyataz ranged around $3,200 per month, with discounts in bulk and managed care settings.

Patent Landscape and Generic Entry Risks

• Patent Expiry: The primary composition patent in the U.S. was expected to expire in March 2024, with regulatory exclusivity ending by 2025.
• Impact of Patent Expiry: Entry of generics could erode sales by 70-80%, consistent with historical reductions seen with other PIs.

Competitive Environment

Reyataz faces competition from:

Competitor	Class	Key Features	Market Share (2022)	Status
Darunavir (Prezista)	Second-generation PI	More potent, resistance profile	35-40%	Dominant
Dolutegravir (Tivicay)	Integrase inhibitor	Once-daily, high barrier to resistance	25-30%	Rapid growth
Elvitegravir/Cobicistat	INSTI + booster	Fixed-dose combinations	15-20%	Increasing

Emerging long-acting injectables (e.g., Cabotegravir/Rilpivirine) threaten oral PIs' positioning, especially in adherence-sensitive populations.

Regulatory & Developmental Trends

• Fixed-Dose Combinations (FDCs): BMS developed Evotaz (atazanavir + cobicistat), enhancing adherence. Regulatory approvals in 2015 expanded indications.
• Long-acting formulations: Currently in Phase III trials; could reshape the treatment landscape.
• Global Access and Regulatory Approvals: Expanded into emerging markets (India, South Africa), driven by WHO prequalification.

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What Does the Financial Trajectory Look Like?

Revenue Forecasts

Year	Projected Revenue (USD)	Comments
2022	~$400 million	Mature sales within U.S. and EU markets
2023	~$350 million	Anticipated decline ahead of patent expiry
2024	~$100-150 million	Sharp decline post patent expiry, unless offset by generics or new formulations
2025-2028	$50-100 million	Marginal revenues from niche markets and combination therapies

Note: The decline hinges on generic entry timelines, market-sharing shifts, and regulatory extensions of patents or exclusivities.

Revenue Drivers

• Patent protection duration: US patent expiry in 2024; potential extensions in select markets.
• Market penetration in emerging economies: Growth driven by affordability and WHO prequalification.
• Combination Therapy Adoption: Increased sales through fixed-dose combinations including Reyataz.

Cost and Pricing Dynamics

Factor	Impact	Description
Patent expiry	Negative	Price erosion with generics
Competition	Negative	More potent, resistant PIs, or INSTIs reduce Reyataz’s attractiveness
Innovation	Positive	Long-acting formulations pose upside potential

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How Is the Global HIV Market Shaping Future Revenue?

Epidemiological Trends

• Global HIV Prevalence: ~38 million (UNAIDS, 2022); stable since 2015, with growth in Africa.
• Treatment Penetration: Approx. 73% of PLHIV receive ART (UNAIDS 2022).
• Market Growth: Driven by expanding access, particularly in low-income and middle-income countries.

Regulatory & Policy Influences

• WHO Guidelines: Endorses integrase inhibitor-based regimens as preferred first-line therapy.
• Patent Laws and Access Policies: Affect local market dynamics; compulsory licensing could accelerate generic entry.
• Donor Funding: Influences drug affordability and uptake, especially in Africa.

Market Segments and Opportunities

Segment	Opportunities	Challenges
Developed markets	Niche use post-patent	Declining sales post-2024
Emerging markets	Volume growth; generic competition	Price pressures, regulatory hurdles
Innovative formulations	Long-acting injectables, SR formulations	Development risk, regulatory approval times

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Comparison: Reyataz vs. Key Competitive Drugs

Attribute	Reyataz (Atazanavir)	Darunavir	Dolutegravir	Long-acting Injectable (Cabotegravir)
Approval Year	2003	2006	2013	2018 (Phase III trials)
Dosing	Once daily	Once daily	Once daily	Monthly/2-monthly injections
Resistance profile	Moderate	Superior	Very high	Not applicable for oral resistance
Patents	Expiring 2024	Active until 2027	Active	Under review, pending approval
Cost	High (pre-generic)	High	Increasing but generally affordable	Premium

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Key Takeaways

• Patent expiration in 2024 is a pivotal inflection point—expected to prompt significant revenue decline unless offset by generics or replacement formulations.
• Market share shifts favor integrase inhibitors and novel long-acting therapies, which could diminish Reyataz's relevance in the oral ART landscape.
• Global expansion and strategies around combination therapies can mitigate some revenue decline, especially in emerging markets.
• Potential growth avenues include embracing innovative formulations, expanding access, and strategic licensing to mitigate generic competition.
• Investment decisions should weigh: the approaching patent cliff, competitive dynamics, regulatory environment, and emerging treatment trends.

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FAQs

Q1: When does Reyataz's patent expire, and what are the implications?

Reyataz's primary U.S. patent expired in March 2024, exposing the drug to generic competition, which could reduce revenues by up to 80% if generics enter the market swiftly.

Q2: How does Reyataz compare to newer antiretroviral drugs?

Reyataz is a first-generation PI with an established profile. Newer drugs like Dolutegravir offer higher resistance barriers, better tolerability, and simpler dosing, making them more preferred in current guidelines.

Q3: Are there any ongoing regulatory efforts to extend Reyataz's market exclusivity?

No significant extensions are currently in place. However, BMS is exploring long-acting formulations and new combinations to sustain relevance beyond patent expiry.

Q4: What role does Reyataz play in the treatment market post-patent expiration?

Post-expiry, Reyataz's revenues are expected to diminish substantially, but it may continue to serve niche segments or be included in generic combination capsules.

Q5: What are the prospects for Reyataz in emerging markets?

Growing access initiatives and WHO prequalification support continued, albeit limited, sales growth in emerging economies, especially via cost-effective generics and fixed-dose combinations.

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References

1. UNAIDS. Global AIDS Update 2022. UNAIDS, 2022.
2. Bristol-Myers Squibb. Reyataz (Atazanavir) Prescribing Information, 2022.
3. FDA. Atazanavir (Reyataz) Approval History, 2003.
4. IQVIA. Global HIV Therapeutics Market Data, 2022.
5. WHO. HIV/AIDS Treatment Guidelines, 2021.

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Disclaimer: The projections and analysis are based on current available data and market trends as of early 2023. Future developments such as new drug approvals, patent litigation, or policy changes could alter the financial trajectory outlined herein.