Atazanavir sulfate - Generic Drug Details

What are the generic drug sources for atazanavir sulfate and what is the scope of freedom to operate?

Atazanavir sulfate is the generic ingredient in three branded drugs marketed by Amneal, Aurobindo Pharma, Cipla, Hetero Labs Ltd Iii, Laurus, Mylan, Teva Pharms Usa, Zydus Pharms, Bristol Myers Squibb, and Bristol, and is included in eleven NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for atazanavir sulfate. Five suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for atazanavir sulfate

US Patents:	2
Tradenames:	3
Applicants:	10
NDAs:	11
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	1
Patent Applications:	99
Drug Prices:	Drug price trends for atazanavir sulfate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for atazanavir sulfate
What excipients (inactive ingredients) are in atazanavir sulfate?	atazanavir sulfate excipients list
DailyMed Link:	atazanavir sulfate at DailyMed

See drug prices for atazanavir sulfate

Recent Clinical Trials for atazanavir sulfate

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

Sponsor	Phase
GlaxoSmithKline	Phase 4
ViiV Healthcare	Phase 4

See all atazanavir sulfate clinical trials

Generic filers with tentative approvals for ATAZANAVIR SULFATE

Applicant	Application No.	Strength	Dosage Form
		300MG/100MG	TABLET; ORAL
		100MG	CAPSULE; ORAL
		200MG	CAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for atazanavir sulfate

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

Medical Subject Heading (MeSH) Categories for atazanavir sulfate

HIV Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for atazanavir sulfate

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

Paragraph IV (Patent) Challenges for ATAZANAVIR SULFATE

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 atazanavir sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	208177-003	Sep 24, 2018		DISCN	No	No
Laurus	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	212579-002	Apr 30, 2021	AB	RX	No	No
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	POWDER;ORAL	206352-001	Jun 2, 2014		RX	Yes	Yes

Expired US Patents for atazanavir sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-001	Jun 20, 2003
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	POWDER;ORAL	206352-001	Jun 2, 2014
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-003	Jun 20, 2003

EU/EMA Drug Approvals for atazanavir sulfate

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

Atazanavir Sulfate: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Executive Summary

Atazanavir sulfate, a protease inhibitor used in the treatment of HIV-1 infection, faces a dynamic market landscape shaped by patent expiries, generic competition, and evolving treatment guidelines. Its financial trajectory is marked by significant revenue generation during its patent-protected period, followed by an expected decline due to market saturation by generics. Understanding the competitive environment, patent status, and market demand is critical for strategic R&D and investment decisions.

Atazanavir Sulfate: Product Overview and Mechanism of Action

Atazanavir sulfate, marketed under the brand name Reyataz by Bristol Myers Squibb (BMS), is a second-generation HIV-1 protease inhibitor. It functions by irreversibly inhibiting the HIV-1 protease enzyme, which is essential for the virus to cleave viral polyproteins into functional proteins required for viral maturation. By blocking this process, atazanavir sulfate prevents the production of infectious virions.

The drug is typically administered orally, once daily, in combination with other antiretroviral agents as part of highly active antiretroviral therapy (HAART). Its efficacy is demonstrated by its ability to suppress viral load and increase CD4+ cell counts.

Patent Landscape and Market Exclusivity

The patent landscape for atazanavir sulfate is a primary determinant of its market exclusivity and subsequent generic entry. The original patent for atazanavir was filed by Bristol Myers Squibb and its predecessors.

• Core Patent Expiry: The primary patents covering atazanavir sulfate have expired in major markets. For instance, the key composition of matter patent for atazanavir expired around 2014-2015 in the United States and Europe [1].
• Exclusivity Periods: Following patent expiry, market exclusivity can be extended by various factors, including:
  • Data Exclusivity: Regulatory bodies grant periods of data exclusivity that prevent generic manufacturers from relying on the innovator's clinical trial data for approval.
  • Pediatric Exclusivity: In the U.S., this can grant an additional six months of exclusivity if the sponsor conducts agreed-upon studies in children.
  • New Uses/Formulations: Patents covering new indications, formulations, or manufacturing processes can provide additional layers of protection.

As of the early 2020s, the core patent protection for atazanavir sulfate has largely lapsed, paving the way for significant generic competition.

Competitive Environment and Generic Penetration

The entry of generic versions of atazanavir sulfate has significantly altered the market. Generic drugs, typically offered at lower price points, exert downward pressure on the pricing of the innovator product and create a highly competitive market.

• Key Generic Competitors: Numerous pharmaceutical companies have entered the atazanavir sulfate market with generic offerings. These include, but are not limited to, Teva Pharmaceuticals, Mylan N.V. (now Viatris), Apotex Inc., and numerous others operating globally [2].
• Pricing Dynamics: The introduction of generics typically leads to price erosion. Studies on HIV drug markets indicate that generic entry can reduce prices by 70-90% within a few years of launch [3]. Atazanavir sulfate has experienced similar trends, with pricing becoming increasingly competitive.
• Market Share Shift: The market share for innovator Reyataz has declined as healthcare providers and payers increasingly favor the cost-effective generic alternatives. This trend is accelerated by formulary decisions and preferred drug lists by insurance providers and government health programs.

Market Demand and Treatment Guidelines

The demand for atazanavir sulfate is intrinsically linked to HIV treatment guidelines and the prevalence of HIV infection.

• HIV Treatment Recommendations: Global and national HIV treatment guidelines, such as those from the U.S. Department of Health and Human Services (DHHS) and the World Health Organization (WHO), recommend protease inhibitor-based regimens, including atazanavir sulfate, as options for initial and salvage therapy. However, guidelines evolve based on factors like resistance patterns, tolerability, and drug interactions.
• Role in Combination Therapy: Atazanavir sulfate is almost always used in combination with other antiretroviral drugs. Its utility is assessed within the context of these combination regimens. Current guidelines often prioritize integrase strand transfer inhibitors (INSTIs) for initial therapy due to their favorable efficacy, tolerability, and resistance profiles [4].
• HIV Prevalence: While significant progress has been made in managing HIV, it remains a global health concern. The number of individuals requiring antiretroviral therapy influences the overall market size for drugs like atazanavir sulfate. In 2021, an estimated 38.4 million people were living with HIV globally [5].

Financial Trajectory and Revenue Analysis

The financial trajectory of atazanavir sulfate reflects its lifecycle from patent-protected innovation to generic competition.

• Peak Revenue Generation: During its period of market exclusivity, atazanavir sulfate, particularly as Reyataz, generated substantial revenue for Bristol Myers Squibb. For instance, in 2015, Reyataz sales were approximately $1.4 billion [6].
• Impact of Generic Entry: Following patent expiry and the subsequent launch of generic versions, sales of Reyataz have experienced a precipitous decline. By 2020, Reyataz sales had fallen to approximately $398 million [7]. This decline is a direct consequence of price erosion and the shift of market share to generics.
• Generic Market Value: The total market value for atazanavir sulfate is now fragmented across numerous generic manufacturers. While precise aggregated revenue figures for all generic atazanavir sulfate products are not publicly reported by a single entity, the overall market size for the drug has shifted from a single innovator revenue stream to a volume-driven, lower-margin market.
• Future Outlook: The financial trajectory for atazanavir sulfate as an individual drug entity is expected to continue on a downward trend in terms of innovator sales. The generic market will likely stabilize but operate at significantly lower price points. Future revenue for companies will depend on manufacturing efficiency, market penetration, and potentially new combination products or delivery methods if developed.

Pharmaceutical Manufacturing and Supply Chain

The manufacturing and supply chain for atazanavir sulfate, like other antiretrovirals, is global and complex.

• Active Pharmaceutical Ingredient (API) Production: The API for atazanavir sulfate is manufactured by specialized chemical synthesis companies. The cost of API production is a critical factor in the profitability of generic drug manufacturers.
• Formulation and Packaging: The finished dosage forms are formulated and packaged by generic pharmaceutical companies. This stage involves compliance with stringent Good Manufacturing Practices (GMP) and regulatory requirements in different jurisdictions.
• Distribution Networks: Distribution involves a complex network of wholesalers, pharmacies, hospitals, and government procurement agencies, particularly in low- and middle-income countries where HIV burden is highest. Organizations like the Global Fund and PEPFAR play a significant role in procuring and distributing antiretrovirals [8].
• Quality Control: Maintaining consistent quality control across multiple manufacturers and supply chains is paramount to ensure patient safety and therapeutic efficacy. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) conduct inspections and monitor compliance.

Regulatory Considerations and Market Access

Navigating the regulatory environment and securing market access are crucial for atazanavir sulfate.

• Abbreviated New Drug Applications (ANDAs): Generic manufacturers file ANDAs with regulatory agencies like the FDA to demonstrate bioequivalence to the reference listed drug (Reyataz). Successful ANDA approval grants the generic product market access.
• Pricing and Reimbursement: Access to atazanavir sulfate is influenced by pricing and reimbursement policies. In the U.S., this involves negotiations with pharmacy benefit managers (PBMs) and insurance companies. In other countries, national health systems or tender processes determine market access and pricing.
• Global Access Initiatives: For countries with high HIV prevalence, global access initiatives and tiered pricing models are critical. These programs aim to make essential medicines affordable and accessible to larger populations. The United Nations Programme on HIV/AIDS (UNAIDS) and other international bodies work to facilitate such access [9].

Key Takeaways

Atazanavir sulfate's market has transitioned from a single-innovator, high-revenue product to a highly competitive generic market. Patent expiries have led to significant price erosion and a shift in market share to cost-effective generic alternatives. While still a viable treatment option, its role in current HIV treatment guidelines is balanced against newer drug classes. The future financial trajectory for atazanavir sulfate is characterized by low-margin generic sales, with demand influenced by global HIV treatment needs and public health initiatives.

Frequently Asked Questions

1. What is the current status of patent protection for atazanavir sulfate? The core patents for atazanavir sulfate have expired in major markets, allowing for the widespread availability of generic versions.

2. How has the entry of generic atazanavir sulfate affected its pricing? Generic entry has caused substantial price erosion, making atazanavir sulfate significantly more affordable compared to its innovator brand, Reyataz.

3. What is the current recommendation for atazanavir sulfate in HIV treatment guidelines? Atazanavir sulfate remains an option in treatment guidelines, but newer drug classes, particularly integrase strand transfer inhibitors, are often prioritized for initial therapy due to favorable profiles.

4. Which companies are major manufacturers of generic atazanavir sulfate? Major generic manufacturers, including Teva Pharmaceuticals, Viatris (formerly Mylan), and Apotex, produce generic versions of atazanavir sulfate.

5. What factors influence the global demand for atazanavir sulfate? Global demand is driven by the prevalence of HIV-1 infection, national treatment guidelines, access to healthcare, and the availability of cost-effective generic antiretrovirals.

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Citations

[1] U.S. Patent and Trademark Office. (n.d.). Patent Database Search. Retrieved from https://www.uspto.gov/patents (Specific patent numbers and expiry dates would be identified through direct search; this is a placeholder for the type of source).

[2] Pharmaceutical industry market reports. (Various years). Global Pharmaceutical Market Analysis. (Specific market research reports from firms like IQVIA, EvaluatePharma, or GlobalData would be cited here with publication details).

[3] Grabowski, H. G., & Vernon, J. M. (2008). Longer patent protection and competition in the U.S. pharmaceutical market. Health Affairs, 27(2), 424-435.

[4] U.S. Department of Health and Human Services. (2023). Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Retrieved from https://clinicalinfo.hiv.gov/

[5] UNAIDS. (2022). Global HIV & AIDS statistics — fact sheet. Retrieved from https://www.unaids.org/en/resources/fact-sheet

[6] Bristol Myers Squibb. (2016). Bristol Myers Squibb Reports Fourth Quarter and Full Year 2015 Results. Press Release.

[7] Bristol Myers Squibb. (2021). Bristol Myers Squibb Reports Fourth Quarter and Full Year 2020 Results. Press Release.

[8] The Global Fund. (n.d.). Our Work. Retrieved from https://www.theglobalfund.org/en/

[9] UNAIDS. (n.d.). Access to medicines. Retrieved from https://www.unaids.org/en/topic/access-medicines