EVOTAZ Drug Patent Profile

Which patents cover Evotaz, and when can generic versions of Evotaz launch?

Evotaz is a drug marketed by Bristol and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and two patent family members in forty-one countries.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atazanavir sulfate; cobicistat profile page.

DrugPatentWatch^® Generic Entry Outlook for Evotaz

Evotaz was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 6, 2032. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for EVOTAZ

International Patents:	302
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Patent Applications:	98
Drug Prices:	Drug price information for EVOTAZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVOTAZ
What excipients (inactive ingredients) are in EVOTAZ?	EVOTAZ excipients list
DailyMed Link:	EVOTAZ at DailyMed

See drug prices for EVOTAZ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EVOTAZ

NDA:

206353

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.

Recent Clinical Trials for EVOTAZ

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

Sponsor	Phase
Gilead Sciences	Phase 3
Bristol-Myers Squibb	Phase 1
St Stephens Aids Trust	Phase 1

See all EVOTAZ clinical trials

Pharmacology for EVOTAZ

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

Paragraph IV (Patent) Challenges for EVOTAZ

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 EVOTAZ

EVOTAZ is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Expired US Patents for EVOTAZ

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 EVOTAZ

When does loss-of-exclusivity occur for EVOTAZ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Peru

Poland

Portugal

San Marino

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EVOTAZ around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2678907	MODULATEURS DE PROPRIETES PHARMACOCINETIQUES DE PRODUITS THERAPEUTIQUES (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS)
Cyprus	1118227
Finland	2049506
Poland	2487162
Singapore	173544	TABLETS FOR COMBINATION THERAPY
South Korea	101636221
Uruguay	25345	SAL DE BISULFATO DEL INHIBIDOR DE LA VIH-PROTEASA

Supplementary Protection Certificates for EVOTAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	132015000080648	Italy		PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(STRIBILD); AUTHORISATION NUMBER(S) AND DATE(S): C(2013)3210, 20130527
2049506	15C0078	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2487163	2016C/066	Belgium		PRODUCT NAME: COBICISTAT ET ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025 20150715
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	93352	Luxembourg		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVAT DE CELUI-CI ET DARUNAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SPLVAT DE CELUI-CI, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967
2049506	CR 2015 00060	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
2049506	SPC/GB15/067	United Kingdom		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527

Market Dynamics and Financial Trajectory of EVOTAZ

Introduction

EVOTAZ, a combination antiretroviral therapy consisting of atazanavir and cobicistat, is a crucial drug in the treatment of HIV-1 infection. To understand its market dynamics and financial trajectory, it is essential to delve into the broader context of the HIV-1 treatment market, as well as specific trends and data related to EVOTAZ.

HIV-1 Treatment Market Overview

The HIV-1 treatment market has undergone significant changes in recent years, driven by advancements in antiretroviral therapies (ARTs) and shifting preferences among patients and healthcare providers.

Shift from Multi-Tablet Regimens (MTRs) to Single-Tablet Regimens (STRs)

There has been a notable shift from MTRs to STRs due to the convenience, adherence benefits, and often superior efficacy of STRs. This trend is reflected in the declining market share of MTRs. For instance, the US market for MTRs for treatment-naïve HIV-1 patients decreased from $5,918 million in 2018 to $3,867 million in 2020, while the market for STRs increased from $10,305 million to $13,620 million during the same period[1].

EVOTAZ in the Market

Approval and Composition

EVOTAZ, approved by the FDA in 2014, combines atazanavir, a protease inhibitor, with cobicistat, a pharmacokinetic enhancer. This combination is often used in conjunction with other antiretroviral drugs.

Market Performance

While EVOTAZ has been a significant player in the HIV-1 treatment market, its sales have been impacted by the rise of newer, more preferred STRs. For example, the launch of Biktarvy (a combination of bictegravir, emtricitabine, and tenofovir alafenamide) in 2018 has significantly altered the market landscape. Biktarvy's excellent safety and efficacy profile, along with its convenience as a single-tablet regimen, have led to a decline in the sales of older regimens, including those involving EVOTAZ[1].

Sales Trends

Historical sales data for EVOTAZ is not as prominently highlighted in recent reports as that of newer drugs like Biktarvy. However, it is clear that the market share of EVOTAZ and similar drugs has been eroding. For example, the sales of Genvoya and Odefsey, both TAF-based regimens, declined after the launch of Biktarvy. This trend suggests that EVOTAZ, being an older regimen, would also face similar market pressures[1].

Competitive Landscape

Rise of Newer Therapies

The HIV-1 treatment market is highly competitive, with newer therapies continually gaining market share. Biktarvy, in particular, has become a market leader, capturing a significant portion of the market previously held by older regimens like EVOTAZ. By 2020, Biktarvy's sales in the US had reached $6,095 million, and it is projected to continue growing, reaching $10,673 million by 2024[1].

Patient and Physician Preferences

Patients and physicians increasingly prefer STRs due to their ease of use and improved adherence rates. This preference has driven the decline of MTRs, including those that involve EVOTAZ. The convenience and efficacy of STRs make them more attractive, further diminishing the market share of older regimens[1].

Financial Implications

Revenue Decline

The decline in market share for EVOTAZ and similar drugs translates into reduced revenue. As newer therapies capture more of the market, the financial performance of older regimens suffers. This is evident from the declining sales figures of other TDF-based and TAF-based regimens, which are likely to mirror the financial trajectory of EVOTAZ[1].

Impact on Pharmaceutical Companies

Pharmaceutical companies that rely heavily on older HIV-1 therapies are adapting to these market changes. For example, Gilead Sciences, the manufacturer of several prominent HIV-1 drugs, has been promoting newer therapies like Biktarvy aggressively. This shift in strategy reflects the need to stay competitive in a market dominated by newer, more preferred treatments[1].

Future Outlook

Market Projections

The US HIV drug market is expected to continue growing, driven by the uptake of novel antiretroviral therapies. However, this growth will likely be skewed towards newer STRs rather than older MTRs like EVOTAZ. The market is projected to exceed billions of dollars in the coming years, with a high compound annual growth rate driven by the adoption of high-potency antiretrovirals[4].

Technological Advancements

Technological advancements and patient-centric approaches by bio-pharmaceutical companies will continue to shape the market. These innovations will further marginalize older therapies, making it essential for companies to invest in research and development to stay competitive[4].

Key Takeaways

• The HIV-1 treatment market is shifting towards Single-Tablet Regimens (STRs) due to their convenience and efficacy.
• EVOTAZ, as an older Multi-Tablet Regimen (MTR), faces declining market share and revenue.
• Newer therapies like Biktarvy are capturing a significant portion of the market.
• Pharmaceutical companies are adapting by promoting newer therapies.
• The US HIV drug market is expected to grow, driven by the adoption of novel antiretroviral therapies.

FAQs

What is EVOTAZ?

EVOTAZ is a combination antiretroviral therapy consisting of atazanavir and cobicistat, used in the treatment of HIV-1 infection.

Why is the market share of EVOTAZ declining?

The market share of EVOTAZ is declining due to the preference for Single-Tablet Regimens (STRs) over Multi-Tablet Regimens (MTRs) and the rise of newer, more effective therapies like Biktarvy.

What are the key drivers of the US HIV drug market?

The key drivers include high exchange rate dynamics, favorable dynamics for high-potency antiretrovirals, and increasing technology development and patient-centric approaches.

How has the launch of Biktarvy impacted the HIV-1 treatment market?

The launch of Biktarvy has significantly altered the market landscape by capturing a large market share from older regimens, including those involving EVOTAZ, due to its excellent safety and efficacy profile.

What is the projected growth of the US HIV drug market?

The US HIV drug market is expected to exceed billions of dollars in the coming years, with a high compound annual growth rate driven by the adoption of novel antiretroviral therapies.

Sources

1. DelveInsight: Changing Dynamics of HIV-1 Treatment Market.
2. PR Newswire: Evofem Biosciences Announces Financial Results for the Third Quarter of 2024.
3. Bristol-Myers Squibb: 2017 Annual Report.
4. GlobeNewswire: United States HIV Infection Drug Market Report 2021-2026.