ATAZANAVIR SULFATE - Generic Drug Details

What are the generic 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. Six 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:	6
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
		200MG	CAPSULE; ORAL
		150MG	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
Aurobindo Pharma	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	204806-002	Jun 25, 2018	AB	RX	No	No
Teva Pharms Usa	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	091673-002	Apr 22, 2014	AB	RX	No	No
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015		RX	Yes	Yes	8,148,374		Y	Y
Amneal	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	209717-002	Jun 1, 2020		DISCN	No	No
Zydus Pharms	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	210575-003	Jun 4, 2020		DISCN	No	No

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	021567-004	Oct 16, 2006	5,849,911*PED
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-001	Jun 20, 2003	5,849,911*PED
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-004	Oct 16, 2006	6,087,383*PED
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	POWDER;ORAL	206352-001	Jun 2, 2014	5,849,911*PED
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-003	Jun 20, 2003	6,087,383*PED

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

Market Dynamics and Financial Trajectory for Atazanavir Sulfate

Last updated: July 28, 2025

Introduction

Atazanavir sulfate is a protease inhibitor primarily prescribed in the management of HIV-1 infection. Since its FDA approval in 2003, it has played a significant role in antiretroviral therapy (ART) regimens. As a component of highly active antiretroviral therapy (HAART), atazanavir's market potential is influenced by evolving HIV treatment paradigms, competitive landscape, patent status, pharmacokinetic advantages, and global health initiatives. This analysis explores the current market dynamics, competitive positioning, and future financial trajectory of atazanavir sulfate within the global pharmaceutical landscape.

Market Overview and Historical Context

The global HIV drug market has exhibited steady growth, propelled by increasing HIV prevalence and expanding access programs, particularly in low- and middle-income regions. Atazanavir's introduction was notable for its once-daily dosing and favorable lipid profile compared to earlier protease inhibitors such as indinavir and saquinavir. These features contributed to its widespread adoption, especially among physicians seeking to minimize adverse effects.

The drug’s revenue generation peaked during the late 2000s to early 2010s, aligning with higher global HIV diagnoses and less competition from newer agents. In 2015, atazanavir was among the top-selling HIV medications, supported by extensive patent protections and branded marketing efforts. As of 2023, the inclusion of atazanavir in various combination regimens remains significant but faces increasing competition from novel classes and fixed-dose combinations.

Market Drivers

1. Clinical Advantages and Patient Adherence

Atazanavir’s once-daily regimen and lower incidence of lipid and gastrointestinal side effects enhance patient adherence—a crucial factor underpinning its sustained demand. Its pharmacokinetic profile facilitates co-formulation with other antiretrovirals, simplifying treatment routines.

2. Global HIV/AIDS Initiatives

International organizations, including UNAIDS and the Global Fund, support treatment access in underserved regions, significantly expanding the eligible patient base. Efforts to curb HIV infection rates further fuel market demand.

3. Patent Expiry and Generics

The patent for atazanavir sulfate expired in several jurisdictions between 2014 and 2018, leading to market entry of generic versions. This has resulted in a substantial price erosion and increased accessibility, especially in developing nations.

4. Emerging Treatment Paradigms

The advent of integrase strand transfer inhibitors (INSTIs), such as dolutegravir, has shifted treatment standards toward drugs with superior efficacy and tolerability profiles. However, atazanavir remains relevant as part of selected combination therapies, especially where cost remains a decisive factor.

Market Constraints and Competitive Landscape

1. Competitive Agents and Evolving Therapeutic Regimens

The rise of more potent, better-tolerated agents, including bictegravir and doravirine, has reduced atazanavir's dominance. Fixed-dose combinations (FDCs) such as bictegravir/emtricitabine/tenofovir have revolutionized ART adherence, often replacing protease inhibitors in preferred regimens.

2. Resistance and Side Effect Profiles

While atazanavir boasts a favorable tolerance profile, its potential for hyperbilirubinemia and its susceptibility to resistance development limit its long-term use in certain patient populations.

3. Price Competition

Generic versions have undercut branded atazanavir, pressuring profit margins. The extent of market share retention depends on pricing strategies and regional reimbursement policies.

Regulatory and Patent Landscape

Patent expirations have democratized access but also intensified competitive pressure. Innovations such as co-formulations and novel delivery systems continue to be areas of interest for manufacturers seeking to extend lifecycle or capture niche segments.

Financial Trajectory and Future Outlook

1. Revenue Projections

Considering patent expirations and market saturation, the revenue from branded atazanavir has declined. According to industry estimates, global sales have decreased by approximately 40% since 2018, with a significant portion attributable to generic proliferation.

2. Market Expansion Potential

Despite challenges, certain markets—such as low-income countries—still rely on originally branded formulations due to procurement channels or licensing agreements. Additionally, in regions with limited access to newer agents, atazanavir remains a vital treatment option.

3. Innovations and Pipeline Developments

No new chemical entities of atazanavir are currently in advanced clinical development. However, ongoing research into long-acting formulations and fixed-dose combinations involving atazanavir could influence future market dynamics positively.

4. Strategic Positioning

Pharmaceutical companies focusing on cost-effective, generic versions are likely to maintain a stable revenue stream. Conversely, branded developers might leverage brand loyalty and clinical differentiation to sustain niche markets.

Global Market Segmentation

The atazanavir sulfate market distribution reflects regional disparities:

• North America and Europe: Dominated by branded formulations, with declining revenues due to generics.
• Asia-Pacific: Growing market share, with increasing access and use of generic and low-cost formulations.
• Africa and Latin America: Heavy reliance on generics, with pricing and supply playing critical roles.

Concluding Remarks

The financial trajectory of atazanavir sulfate is characterized by a declining trend in mature markets, driven by patent expiration, competition from newer drugs, and evolving treatment guidelines favoring INSTIs and integrase inhibitors. Nonetheless, the global HIV treatment landscape necessitates a durable presence of cost-effective protease inhibitors like atazanavir, especially in resource-constrained settings. Future growth hinges on innovations in formulation, strategic licensing, and expanding access in underserved populations.

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Key Takeaways

• Atazanavir sulfate remains relevant in specific segment niches, particularly in cost-sensitive markets and as part of combination regimens.
• Patent expirations have catalyzed generic entry, significantly impacting revenue streams but increasing global access.
• Competition from newer antiretroviral agents, primarily INSTIs, has reduced atazanavir’s market dominance.
• Ongoing innovations in drug delivery and fixed-dose formulations could revitalise its market segment.
• Regional differences influence market dynamics, with developing countries showing sustained demand due to affordability and accessibility.

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FAQs

1. How does patent expiry influence atazanavir’s market share?
Patent expiry allows generic manufacturers to produce cost-effective versions, leading to significant price reductions. This increases accessibility but decreases revenue for original developers, thus shifting market share toward generics in many regions.

2. What are the primary clinical advantages of atazanavir compared to other protease inhibitors?
Atazanavir is associated with once-daily dosing and a lower incidence of lipid abnormalities and gastrointestinal side effects, improving patient adherence and tolerability.

3. Why are newer classes of antiretrovirals supplanting atazanavir in treatment regimens?
Integrase inhibitors like dolutegravir offer superior efficacy, better tolerability, fewer drug interactions, and simplified dosing, making them preferred over protease inhibitors in many cases.

4. What future innovations could sustain atazanavir’s market presence?
Development of long-acting formulations, co-formulated fixed-dose combinations, and strategic licensing agreements could extend its lifecycle and maintain demand in targeted markets.

5. How does the global HIV epidemic influence atazanavir’s market outlook?
Growing HIV prevalence and expanding treatment access in underserved regions offer ongoing demand, particularly where cost-effective options are prioritized. international health initiatives continue to support broader access to antiretroviral medications, benefiting atazanavir’s market sustainability.

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Sources

[1] U.S. Food and Drug Administration. (2003). FDA approves atazanavir for HIV infection. FDA.gov.

[2] GlobalData Healthcare. (2023). HIV drug market analysis.

[3] UNAIDS. (2022). Global HIV/AIDS statistics and treatment data.

[4] IQVIA. (2022). Global pharmaceutical sales reports.

[5] Research and Markets. (2022). Protease inhibitor market outlook.