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. Eight 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:	84
Clinical Trials:	67
Patent Applications:	5,261
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	CAPSULE;ORAL	021567-001	Jun 20, 2003
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	POWDER;ORAL	206352-001	Jun 2, 2014

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/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

International Patents for REYATAZ

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

Country	Patent Number	Title	Estimated Expiration
Norway	20003692
Estonia	04434	HIV proteaasi inhibiitori bisulfaatsool
Lithuania	4780	ŽIV PROTEAZĖS INHIBITORIAUS RŪGŠTUSIS SULFATAS (BISULFATE SALT OF HIV PROTEASE INHIBITOR)

Supplementary Protection Certificates for REYATAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	2016/062	Ireland		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REGISTRATION NO/DATE: EU/1/15/1025 20160713
2487163	CA 2017 00003	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG ATAZANAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER ATAZANAVIRSULFAT; REG. NO/DATE: EU/1/15/1025/001-002 20150715
0900210	SPC023/2005	Ireland		SPC023/2005, 20060612, EXPIRES: 20190301

REYATAZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for REYATAZ

Introduction

REYATAZ, a protease inhibitor containing the active substance atazanavir, is a crucial medication in the treatment of HIV-1 infection. Here, we delve into the market dynamics and financial trajectory of REYATAZ, examining its performance, clinical efficacy, and market impact.

Clinical Efficacy of REYATAZ

REYATAZ has been extensively studied in various clinical trials to assess its efficacy in treating HIV-1 infection. The drug is indicated for use in combination with other antiretroviral agents and has shown significant effectiveness in reducing viral loads and improving immune system parameters.

• Adult Studies: In patients who had not received HIV treatment before, ritonavir-boosted REYATAZ was as effective as ritonavir-boosted lopinavir, with 78% of patients achieving viral loads below 50 copies/ml after 48 weeks[4][5].
• Pediatric Studies: In children aged between 6 and 18 years, REYATAZ also demonstrated efficacy, with 81% of treatment-naive patients and 24% of treatment-experienced patients achieving undetectable viral loads after 48 weeks[4].

Market Positioning

REYATAZ is part of the broader HIV drug market, which has seen significant growth and innovation in recent years.

• US HIV Drug Market: The US HIV drug market is characterized by high growth rates, driven by the success of antiretroviral therapies and the continuous development of new treatments. The market is expected to exceed billions of dollars in the coming years, with a high compound annual growth rate (CAGR)[1].

Financial Performance

The financial performance of REYATAZ can be inferred from the broader context of the HIV drug market and the sales data of similar antiviral medications.

• Sales Trends: While specific quarterly sales data for REYATAZ are not provided, antiviral drugs like REYATAZ generally follow a trend of increasing sales in the initial years after launch, followed by a plateau or slight decline as other drugs enter the market. For example, Avycaz, another antiviral, reached $99.54 million in its 24th quarter on the market[3].
• Revenue Growth: The overall revenue from HIV drugs, including REYATAZ, is driven by factors such as increased uptake of novel products and favorable market dynamics. The net manufacturer revenue generated by the HIV drug market is expected to grow significantly, contributing to the market's exponential CAGR[1].

Competitive Landscape

REYATAZ operates within a competitive landscape dominated by several key players in the pharmaceutical industry.

• Key Players: Companies like Bristol-Myers Squibb, the sponsor of REYATAZ, play a significant role in the HIV drug market. These companies invest heavily in research and development, leading to the launch of novel products and therapies that drive market growth[2][5].
• Market Segments: The HIV drug market is segmented based on the type of antiretroviral therapy, patient population, and geographic region. REYATAZ, being a protease inhibitor, competes within the segment of combination therapies that include other antiretroviral agents[1].

Regulatory Environment

The regulatory environment is crucial for the approval and continued use of REYATAZ.

• FDA Approval: REYATAZ was approved by the FDA in 2003 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. The approval process involved comprehensive clinical trials and reviews by regulatory bodies[5].
• European Approval: REYATAZ is also approved by the European Medicines Agency (EMA), which has assessed its efficacy and safety in various patient populations[4].

Patient-Centric Approaches

The success of REYATAZ and other HIV drugs is also influenced by patient-centric approaches adopted by pharmaceutical companies.

• Patient Care: Bio-pharmaceutical companies are increasingly focusing on patient-centric strategies to improve healthcare outcomes. This includes better access to medications, patient support programs, and innovative delivery mechanisms[1].

Technological Advancements

Technological advancements in drug development and delivery are further enhancing the market dynamics for REYATAZ.

• Innovative Formulations: The availability of REYATAZ in various formulations, such as capsules and oral powder, makes it more accessible and convenient for patients. This technological development is a democratizing force, enabling more patients to benefit from the treatment[4].

Market Growth Drivers

Several factors drive the growth of the market in which REYATAZ operates.

• Research and Development: The continuous investment in research and development is a key driver, leading to the launch of novel products and therapies. This has resulted in a high success rate for antiretroviral treatments, including REYATAZ[1].
• High Potent Antiretrovirals: The favorable dynamics for high potent antiretrovirals, such as REYATAZ, contribute to the market's exponential growth. The high exchange rate dynamics and increased spending on HIV treatments also play significant roles[1].

Challenges and Opportunities

Despite the positive market dynamics, there are challenges and opportunities that affect the financial trajectory of REYATAZ.

• Competition: The HIV drug market is highly competitive, with numerous antiretroviral therapies available. This competition can impact the sales and market share of REYATAZ[1].
• Emerging Therapies: The emergence of new therapies and treatment regimens presents both challenges and opportunities. While new drugs can compete with REYATAZ, they also drive overall market growth and innovation[1].

Key Takeaways

• Clinical Efficacy: REYATAZ has demonstrated significant efficacy in reducing viral loads and improving immune system parameters in both adult and pediatric populations.
• Market Growth: The US HIV drug market, where REYATAZ operates, is expected to grow exponentially, driven by the success of antiretroviral therapies and continuous innovation.
• Financial Performance: The financial performance of REYATAZ is influenced by its sales trends, competitive landscape, and the overall growth of the HIV drug market.
• Regulatory and Technological Factors: Regulatory approvals and technological advancements in drug formulations and delivery mechanisms are crucial for the market success of REYATAZ.

FAQs

What is REYATAZ used for?

REYATAZ is a protease inhibitor used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Who is the sponsor of REYATAZ?

REYATAZ is sponsored by Bristol-Myers Squibb Company.

How effective is REYATAZ in reducing viral loads?

In clinical trials, REYATAZ has shown to be highly effective in reducing viral loads, with 78% of treatment-naive patients achieving viral loads below 50 copies/ml after 48 weeks.

What are the available formulations of REYATAZ?

REYATAZ is available as capsules (100 mg, 150 mg, 200 mg, and 300 mg) and oral powder.

How does the competitive landscape affect REYATAZ?

The competitive landscape of the HIV drug market, with numerous antiretroviral therapies available, can impact the sales and market share of REYATAZ, but it also drives overall market growth and innovation.

Sources

1. United States HIV Infection Drug Market Report 2021-2026 - ResearchAndMarkets.com
2. Our People | Biohaven - Biohaven
3. MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs - NCBI
4. Reyataz | European Medicines Agency (EMA)
5. REYATAZ Atazanavir Sulfate - FDA Access Data