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GENVOYA Drug Patent Profile

Which patents cover Genvoya, and what generic alternatives are available?

Genvoya is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has five hundred and twenty-six patent family members in fifty-six countries.

The generic ingredient in GENVOYA is cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Genvoya

Genvoya was eligible for patent challenges on November 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 6, 2033. This may change due to patent challenges or generic licensing.

There have been twenty-three 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 GENVOYA

International Patents:	526
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	19
Drug Prices:	Drug price information for GENVOYA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GENVOYA
What excipients (inactive ingredients) are in GENVOYA?	GENVOYA excipients list
DailyMed Link:	GENVOYA at DailyMed

See drug prices for GENVOYA

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

Constraining patent/regulatory exclusivity:

10,039,718*PED

NDA:

207561

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 GENVOYA

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

Sponsor	Phase
St. Michael's Hospital, Toronto	Phase 2
CIHR Canadian HIV Trials Network	Phase 2
Unity Health Toronto	Phase 2

See all GENVOYA clinical trials

Pharmacology for GENVOYA

Drug Class	Cytochrome P450 3A Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for GENVOYA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GENVOYA	Tablets	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	150 mg/150 mg/ 200 mg/10 mg	207561	1	2023-04-12

US Patents and Regulatory Information for GENVOYA

GENVOYA is protected by ten US patents.

This potential generic entry date is based on patent 10,039,718.

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
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	8,754,065*PED				Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	7,635,704*PED				Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	9,891,239*PED				Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	8,148,374*PED				Y
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	8,981,103*PED				Y

Expired US Patents for GENVOYA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	5,814,639*PED
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	7,803,788
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	7,800,788
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	6,703,396*PED
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	5,914,331*PED

International Patents for GENVOYA

When does loss-of-exclusivity occur for GENVOYA?

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 GENVOYA around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	S1300066
Croatia	P20030047	PROLIJEKOVI KOJI SU FOSFONATNI ANALOZI NUKLEOTIDA I METODE NJIHOVOG ODABIRA TE NJIHOVA PRIPRAVA (PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME)
Spain	2329240
Israel	195488	תרכובות, תכשירים רוקחיים המכילים אותן ושימושים שלהם (Compounds, pharmaceutical compositions comprising the same and uses thereof)
European Patent Office	3070088	TÉNOFOVIR ALAFENAMIDE HÉMIFUMARATE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)

Supplementary Protection Certificates for GENVOYA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1564210	132013902209844	Italy		PRODUCT NAME: COMPRENDENTE IL PRODOTTO ELVITEGRAVIR COME UNO DEI PRINCIPI ATTIV(STRIBILD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/830/001-002, 20130524
3150586	PA2020508	Lithuania		PRODUCT NAME: KOBICISTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921
0513200	C00513200/01	Switzerland		PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
2487163	381 2-2017	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/ATAZANAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1025 20150715
1564210	PA2013018,C1564210	Lithuania		PRODUCT NAME: ELVITEGRAVIRUM; REGISTRATION NO/DATE: EU/1/13/830/001, 2013-05-24 EU/1/13/830/002 20130524

GENVOYA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Genvoya

Introduction

Genvoya, a single-tablet regimen developed by Gilead Sciences, has been a significant player in the HIV treatment market since its launch in 2015. This article delves into the market dynamics and financial trajectory of Genvoya, highlighting its impact on Gilead's portfolio and the broader HIV treatment landscape.

Launch and Initial Success

Genvoya was introduced in December 2015 as a quadruple-drug tablet, combining elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. Within six months of its launch, Genvoya became the most-prescribed HIV drug for patients new to antivirals and those switching from another regimen, marking the most successful HIV launch since the introduction of Atripla a decade earlier[1].

Sales Performance

In its first six months, Genvoya generated $302 million in worldwide sales, with sales nearly doubling in the second quarter compared to the first quarter. This rapid uptake contributed significantly to Gilead's HIV revenue, which grew to $3.1 billion for the period[1].

Market Share and Prescription Trends

Genvoya's success was largely driven by switches from other Gilead treatments, with more than 78% of Genvoya prescriptions coming from patients switching from Gilead's "quad" pill Stribild and its predecessor Atripla. Only 10% of these switches came from non-Gilead medications, indicating strong brand loyalty and a preference for Gilead's HIV treatment portfolio[1].

Competitive Landscape

Genvoya operates in a competitive HIV market, but its unique formulation and efficacy have helped it maintain a strong position. As of 2019, Gilead held a 53% market share in the HIV sector, significantly ahead of its closest competitor, GSK, which held a 23% share[4].

Financial Impact on Gilead

The success of Genvoya has been a key factor in Gilead's financial performance. In 2018, Genvoya sales reached $4.624 billion, contributing substantially to Gilead's revenue. This success, along with other HIV treatments like Biktarvy and Descovy, has helped offset declines in other product lines, such as those affected by the COVID-19 pandemic[4].

Full-Year Financial Performance

In the full year 2020, despite the challenges posed by COVID-19, Gilead's HIV product sales, including Genvoya, increased by 3% to $16.9 billion. This growth was driven by the continued patient uptake of Biktarvy and the growth of Descovy for pre-exposure prophylaxis (PrEP)[3].

Product Gross Margin and Costs

Genvoya's financial performance is also reflected in Gilead's product gross margin. In 2023, the product gross margin was 75.9%, slightly lower than the previous year due to restructuring expenses and increased amortization costs. However, the non-GAAP product gross margin remained robust at 86.3%, indicating the profitability of Genvoya and other HIV treatments[2].

Research and Development Expenses

Gilead's investment in research and development (R&D) has been crucial for the success of Genvoya and other HIV treatments. In 2023, R&D expenses increased to $5.7 billion, reflecting increased clinical activities across Gilead's Oncology and Virology programs, including those related to HIV[2].

Future Forecasts and Market Position

Looking ahead, Genvoya is expected to continue playing a significant role in Gilead's HIV portfolio. While newer treatments like Biktarvy are forecasted to achieve higher sales, Genvoya's established market presence ensures it will remain a key player. Forecasted sales of other HIV therapies, including Biktarvy, suggest that Gilead will maintain its leading position in the HIV market for years to come[4].

Challenges and Opportunities

Despite its success, Genvoya faces challenges such as competition from newer treatments and potential changes in market dynamics. However, Gilead's strong pipeline and continued innovation in HIV treatments position the company well to address these challenges. The company's ability to adapt to market changes, such as the impact of COVID-19 on healthcare, has also been a factor in its sustained success[3].

Key Takeaways

• Rapid Market Adoption: Genvoya became the most-prescribed HIV drug within six months of its launch.
• Strong Financial Performance: Genvoya contributed significantly to Gilead's HIV revenue, reaching $4.624 billion in sales in 2018.
• Market Share: Gilead held a 53% market share in the HIV sector as of 2019, driven partly by Genvoya's success.
• Financial Impact: Genvoya's success has helped offset declines in other product lines and contributed to Gilead's overall financial performance.
• Future Prospects: Genvoya is expected to continue playing a significant role in Gilead's HIV portfolio, despite the rise of newer treatments.

FAQs

What was the initial market response to Genvoya upon its launch?

Genvoya became the most-prescribed HIV drug for patients new to antivirals and those switching from another regimen within six months of its launch, marking the most successful HIV launch since the introduction of Atripla[1].

How has Genvoya impacted Gilead's financial performance?

Genvoya has significantly contributed to Gilead's HIV revenue, with sales reaching $4.624 billion in 2018. It has helped offset declines in other product lines and contributed to Gilead's overall financial performance[4].

What percentage of Genvoya prescriptions came from switches from other Gilead treatments?

More than 78% of Genvoya prescriptions came from patients switching from other Gilead treatments, such as Stribild and Atripla[1].

How does Genvoya compare to other HIV treatments in terms of market share?

As of 2019, Gilead held a 53% market share in the HIV sector, significantly ahead of its closest competitor, GSK, which held a 23% share. Genvoya's success has been a key factor in this market dominance[4].

What are the future prospects for Genvoya in the HIV market?

Genvoya is expected to continue playing a significant role in Gilead's HIV portfolio, although newer treatments like Biktarvy are forecasted to achieve higher sales. Gilead's strong pipeline and continued innovation ensure its leading position in the HIV market[4].

Sources

1. FiercePharma: Gilead's new launch Genvoya racks up big script growth in fastest HIV rollout since Atripla[1].
2. Gilead Sciences: Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results[2].
3. Gilead Sciences: Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results[3].
4. Clarivate: Biktarvy, the booming blockbuster, drives HIV market[4].