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. Eight 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:	8
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	1
Patent Applications:	47
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
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015		RX	Yes	Yes	8,148,374		Y	Y
Cipla	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	200626-004	Aug 9, 2018		DISCN	No	No
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-003	Jun 20, 2003	AB	RX	Yes	No
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-001	Jun 20, 2003		DISCN	Yes	No
Cipla	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	200626-003	Aug 9, 2018		DISCN	No	No
Cipla	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	200626-001	Aug 9, 2018		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	POWDER;ORAL	206352-001	Jun 2, 2014	6,087,383*PED
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-003	Jun 20, 2003	6,087,383*PED
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-004	Oct 16, 2006	6,087,383*PED
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-003	Jun 20, 2003	5,849,911*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/000494 Reyataz 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 Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Atazanavir Sulfate

Introduction

Atazanavir sulfate, marketed under the brand name REYATAZ, is a protease inhibitor used in the treatment of HIV-1 infection. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting its current status, growth prospects, and key factors influencing its market performance.

Market Size and Growth Prospects

The global Atazanavir sulfate market is anticipated to experience significant growth over the forecast period. According to market research reports, the market is expected to grow at a Compound Annual Growth Rate (CAGR) of 10.9% during the forecast period, reflecting a robust growth trajectory[3].

Current Market Value

As of recent estimates, the global Atazanavir sulfate market size was valued at a substantial amount in 2018 and is projected to expand further from 2019 to 2025. The exact figures indicate a steady increase in market value, driven by increasing demand for effective HIV treatments[4].

Therapeutic Indications and Mechanism

Atazanavir sulfate is specifically indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. It functions as an HIV-1 protease inhibitor, which is crucial for the replication of the virus. This mechanism makes it an essential component in the treatment regimen for HIV patients[5].

Regulatory Approvals and History

Atazanavir sulfate was first approved by the US FDA on June 20, 2003. Since then, it has undergone several supplemental approvals, including the most recent in 2009, which expanded its dosing and usage guidelines. These approvals have been instrumental in its market acceptance and growth[5].

Clinical Trials and Phases

The drug has been involved in numerous clinical trials across various phases. For instance, Phase 3 trials have been conducted to evaluate its efficacy in combination with other antiretroviral agents, such as ritonavir, tenofovir, and FTC. These trials have demonstrated its safety and efficacy, contributing to its market stability[2].

Market Drivers

Several factors drive the growth of the Atazanavir sulfate market:

• Increasing Prevalence of HIV: The rising number of HIV cases globally increases the demand for effective antiretroviral therapies.
• Advancements in Treatment Regimens: Continuous improvements in treatment protocols and the introduction of combination therapies have boosted the market.
• Government Initiatives: Public health initiatives and funding for HIV research and treatment also contribute to market growth.

Market Restraints

Despite the growth prospects, there are several challenges:

• Side Effects and Adverse Reactions: Atazanavir sulfate is associated with side effects such as nausea, jaundice, rash, and cardiac conduction abnormalities, which can impact patient compliance and market growth[5].
• Drug Interactions: The drug interacts with various other medications, which can complicate treatment regimens and affect market performance.
• Generic Competition: The potential entry of generic versions could reduce the market share of branded Atazanavir sulfate.

Financial Performance

The financial trajectory of Atazanavir sulfate is influenced by its sales performance and market share. The drug has been a significant contributor to the revenue of its manufacturer, Bristol-Myers Squibb. The approval of supplemental indications and the expansion of its market reach have positively impacted its financial performance.

Competitive Landscape

The antiretroviral market is highly competitive, with several other protease inhibitors and combination therapies available. Atazanavir sulfate competes with drugs like lopinavir/ritonavir and darunavir. However, its unique dosing regimen and once-daily administration have helped it maintain a strong market position.

Regional Market Analysis

The market for Atazanavir sulfate varies by region, with significant demand in areas with high HIV prevalence. Regions such as North America, Europe, and certain parts of Africa and Asia are key markets due to their large patient populations and advanced healthcare systems.

Future Outlook

The future outlook for Atazanavir sulfate is promising, driven by ongoing research and development in HIV treatment. The drug's inclusion in various combination therapies and its potential use in new indications, such as hyperlipidemias, further enhance its market prospects[2].

Key Takeaways

• Growth Prospects: The Atazanavir sulfate market is expected to grow at a CAGR of 10.9% during the forecast period.
• Therapeutic Indications: It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.
• Regulatory Approvals: First approved in 2003, with subsequent supplemental approvals.
• Market Drivers: Increasing HIV prevalence, advancements in treatment regimens, and government initiatives.
• Market Restraints: Side effects, drug interactions, and potential generic competition.
• Financial Performance: Significant revenue contributor for Bristol-Myers Squibb.

FAQs

What is Atazanavir sulfate used for?

Atazanavir sulfate is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

When was Atazanavir sulfate first approved?

Atazanavir sulfate was first approved by the US FDA on June 20, 2003.

What are the common side effects of Atazanavir sulfate?

Common side effects include nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, and peripheral neurologic symptoms[5].

How does Atazanavir sulfate work?

It functions as an HIV-1 protease inhibitor, which is crucial for the replication of the HIV virus.

What are the potential market restraints for Atazanavir sulfate?

Potential restraints include side effects, drug interactions, and the potential entry of generic versions.