ATAZANAVIR SULFATE; COBICISTAT - Generic Drug Details

What are the generic drug sources for atazanavir sulfate; cobicistat and what is the scope of patent protection?

Atazanavir sulfate; cobicistat is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Atazanavir sulfate; cobicistat has two hundred and ninety-five patent family members in forty countries.

One supplier is listed for this compound.

Summary for ATAZANAVIR SULFATE; COBICISTAT

International Patents:	295
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATAZANAVIR SULFATE; COBICISTAT
DailyMed Link:	ATAZANAVIR SULFATE; COBICISTAT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ATAZANAVIR SULFATE; COBICISTAT

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ATAZANAVIR SULFATE; COBICISTAT

Drug Class

Cytochrome P450 3A Inhibitor Protease Inhibitor

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors UDP Glucuronosyltransferases Inhibitors UGT1A1 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ATAZANAVIR SULFATE; COBICISTAT

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

V03AX	Other therapeutic products
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for ATAZANAVIR SULFATE; COBICISTAT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EVOTAZ	Tablets	atazanavir sulfate; cobicistat	300 mg/150 mg	206353	1	2017-09-13

US Patents and Regulatory Information for ATAZANAVIR SULFATE; COBICISTAT

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			Y
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015		RX	Yes	Yes			Y	Y

Expired US Patents for ATAZANAVIR SULFATE; COBICISTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015

International Patents for ATAZANAVIR SULFATE; COBICISTAT

Country	Patent Number	Title	Estimated Expiration
Singapore	10201706215U	Tablets for combination therapy
Ukraine	101193	ПРИМЕНЕНИЕ ЧАСТИЧЕК ТВЕРДОГО НОСИТЕЛЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА;ЗАСТОСУВАННЯ ЧАСТИНОК ТВЕРДОГО НОСІЯ ДЛЯ ПОЛІПШЕННЯ ТЕХНОЛОГІЧНИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧНОГО АГЕНТА (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Portugal	2487163
Australia	2010210598	Tablets for combination therapy
Cyprus	1118292
Argentina	061838	MODULADORES DE PROPIEDADES FARMACOCINETICAS DE TERAPEUTICOS
Australia	2016250470	THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

Supplementary Protection Certificates for ATAZANAVIR SULFATE; COBICISTAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	15C0078	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2487166	PA2016038	Lithuania		PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2487162	61/2016	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSVBESONDERE DARUNAVIR-ETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 (MITTEILUNG) 20141121
2487163	1790002-8	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/15/1025, 2015-07-15
2487166	300860	Netherlands		PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123
2487162	2016/063	Ireland		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE; REGISTRATION NO/DATE: EU/1/14/967 20141119
2049506	1590060-8	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF

ATAZANAVIR SULFATE; COBICISTAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Atazanavir Sulfate and Cobicistat

Introduction

Atazanavir sulfate, marketed as Reyataz, and cobicistat, a pharmacokinetic enhancer, have been pivotal in the treatment of HIV-1 infection. The combination of these two drugs has significant implications for market dynamics and financial trajectories in the pharmaceutical industry.

Historical Context of Atazanavir Sulfate

Atazanavir sulfate, developed by Bristol-Myers Squibb, was first approved in 2003 for the treatment of HIV-1 infection. Since its launch, it has been widely used, particularly in combination with other antiretroviral agents and the pharmacokinetic enhancer ritonavir[5].

Emergence of Cobicistat

Cobicistat, developed by Gilead Sciences, is a novel pharmacoenhancer that has been designed to boost the plasma levels of protease inhibitors like atazanavir without having antiretroviral activity itself. This distinguishes it from ritonavir, which has antiretroviral properties[2][4].

Clinical Efficacy and Safety

Clinical trials have demonstrated that cobicistat is noninferior to ritonavir when used to boost atazanavir in combination with emtricitabine and tenofovir disoproxil fumarate (FTC/TDF). These trials showed high rates of virologic success and comparable safety and tolerability profiles between the two regimens[2][4][5].

Market Impact of the Combination

The approval and subsequent marketing of a fixed-dose combination tablet of atazanavir sulfate and cobicistat have significant market implications. This single-tablet regimen simplifies treatment for patients, potentially increasing adherence and reducing the pill burden. This convenience can lead to higher patient satisfaction and better treatment outcomes, which in turn can drive market demand[5].

Financial Trajectory

Revenue and Market Share

Since its launch, atazanavir sulfate has generated substantial revenue for Bristol-Myers Squibb. With approximately 245,000 patients in the U.S. treated with Reyataz since 2003, it has established a strong market presence. The introduction of a fixed-dose combination with cobicistat is expected to further enhance revenue by offering a more convenient treatment option, potentially increasing market share in the HIV treatment market[5].

Licensing and Collaboration

The licensing agreement between Bristol-Myers Squibb and Gilead Sciences for the development and commercialization of the atazanavir sulfate and cobicistat combination has been a strategic move. This collaboration allows both companies to leverage their strengths in formulation, manufacturing, and distribution, potentially leading to increased financial returns through shared resources and expertise[5].

Cost-Benefit Analysis

The use of cobicistat instead of ritonavir offers several cost-benefit advantages. Cobicistat has fewer drug-drug interactions and better solubility, which can lead to better tolerability and potentially higher lifelong treatment adherence. This can result in lower long-term healthcare costs associated with managing side effects and complications, making the treatment more cost-effective for both patients and healthcare systems[1][4].

Competitive Landscape

The HIV treatment market is highly competitive, with several antiretroviral therapies available. However, the combination of atazanavir sulfate and cobicistat stands out due to its once-daily dosing regimen and the convenience of a single tablet. This differentiates it from other treatments that may require multiple tablets or more frequent dosing, giving it a competitive edge in the market[5].

Regulatory Approvals and Clinical Trials

The submission of the new drug application (NDA) for the fixed-dose combination of atazanavir sulfate and cobicistat to the U.S. FDA marked a significant step forward. Clinical trials, such as Study 114, have provided robust data supporting the efficacy and safety of this combination, which is crucial for regulatory approvals and subsequent market acceptance[5].

Patient Adherence and Treatment Outcomes

Patient adherence is a critical factor in the success of HIV treatment regimens. The simplicity of a once-daily, single-tablet regimen can significantly improve adherence rates, leading to better treatment outcomes. As Dr. Calvin J. Cohen noted, "Adhering to HIV treatment regimens can be challenging for some patients, and if the prescribed medications are not taken properly, it could result in treatment failure"[5].

Future Prospects

The combination of atazanavir sulfate and cobicistat is part of a broader strategy by pharmaceutical companies to simplify HIV treatment and improve patient outcomes. With ongoing research and development in antiretroviral therapies, this combination is likely to remain a significant player in the market. The financial trajectory is expected to be positive, driven by increased adoption and the potential for expanded indications, such as use in patients with cardiovascular disease and chronic kidney disease[1][5].

Key Takeaways

• Clinical Efficacy: Cobicistat is noninferior to ritonavir in boosting atazanavir, with high rates of virologic success and comparable safety profiles.
• Market Impact: The fixed-dose combination simplifies treatment, potentially increasing adherence and market demand.
• Financial Trajectory: Expected to enhance revenue through increased market share and cost-benefit advantages.
• Competitive Edge: Once-daily, single-tablet regimen differentiates it from other treatments.
• Regulatory Approvals: Supported by robust clinical trial data.
• Patient Adherence: Simplified regimen improves adherence rates, leading to better treatment outcomes.

FAQs

Q: What is the primary advantage of using cobicistat over ritonavir in HIV treatment?

A: Cobicistat has fewer drug-drug interactions, better solubility, and no antiretroviral activity, making it a more convenient and potentially more tolerable option.

Q: How does the combination of atazanavir sulfate and cobicistat impact patient adherence?

A: The once-daily, single-tablet regimen simplifies treatment, which can significantly improve patient adherence rates.

Q: What are the key clinical trials that support the use of atazanavir sulfate and cobicistat?

A: Study 114 and other phase 3 trials have demonstrated the efficacy and safety of this combination.

Q: How does this combination affect the financial trajectory for Bristol-Myers Squibb and Gilead Sciences?

A: The combination is expected to enhance revenue through increased market share and cost-benefit advantages, driven by the convenience and efficacy of the single-tablet regimen.

Q: Are there any specific patient populations that benefit more from this combination?

A: Patients with cardiovascular disease and chronic kidney disease may particularly benefit from the atazanavir sulfate and cobicistat combination due to its favorable tolerability and safety profile.

Sources

1. Atazanavir sulfate + cobicistat for the treatment of HIV infection - PubMed[1]
2. Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir ... - PubMed[2]
3. Bristol-Myers Squibb 2013 Annual Report - Bristol-Myers Squibb[3]
4. Cobicistat Versus Ritonavir as a Pharmacoenhancer of Atazanavir ... - Oxford Academic[4]
5. Bristol-Myers Squibb Submits New Drug Application to U.S. FDA for a Fixed-Dose Combination Tablet of Atazanavir Sulfate with Cobicistat for People Living with HIV-1 - Bristol-Myers Squibb[5]