DESCOVY Drug Patent Profile

When do Descovy patents expire, and what generic alternatives are available?

Descovy is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-three patent family members in fifty-one countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Descovy

A generic version of DESCOVY was approved as emtricitabine; tenofovir alafenamide fumarate by LUPIN LTD on December 13^th, 2024.

Summary for DESCOVY

International Patents:	133
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	18
Drug Prices:	Drug price information for DESCOVY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESCOVY
What excipients (inactive ingredients) are in DESCOVY?	DESCOVY excipients list
DailyMed Link:	DESCOVY at DailyMed

See drug prices for DESCOVY

Recent Clinical Trials for DESCOVY

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

Sponsor	Phase
National University Hospital, Singapore	PHASE1
ANRS, Emerging Infectious Diseases	Phase 3
Chiang Mai University, Thailand	Phase 3

See all DESCOVY clinical trials

Pharmacology for DESCOVY

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Paragraph IV (Patent) Challenges for DESCOVY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DESCOVY	Tablets	emtricitabine; tenofovir alafenamide fumarate	120 mg/15 mg	208215	1	2022-10-31
DESCOVY	Tablets	emtricitabine; tenofovir alafenamide fumarate	200 mg/25 mg	208215	6	2019-11-05

US Patents and Regulatory Information for DESCOVY

DESCOVY is protected by three US patents and two FDA Regulatory Exclusivities.

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	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No	7,390,791*PED				Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	AB	RX	Yes	Yes	8,754,065*PED				Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No

Expired US Patents for DESCOVY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	5,814,639*PED
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	6,703,396*PED
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	7,803,788

International Patents for DESCOVY

When does loss-of-exclusivity occur for DESCOVY?

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

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Mexico

Moldova, Republic of

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Serbia

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 DESCOVY around the world.

Country	Patent Number	Title	Estimated Expiration
Ukraine	115311	ГЕМІФУМАРАТ ТЕНОФОВІРУ АЛАФЕНАМІДУ (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Peru	20141328	TENOFOVIR ALAFENAMIDA HEMIFUMARATO
Japan	2014528924

Supplementary Protection Certificates for DESCOVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0513200	C00513200/01	Switzerland		PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
1663240	2015/053	Ireland		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	SPC/GB15/064	United Kingdom		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTERED: UK EU/1/11/737/001-002 20111128

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DESCOVY

Last updated: July 27, 2025

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Introduction

DESCOVY, developed by Gilead Sciences, Inc., is a combination antiretroviral medication primarily used for the treatment and prevention of HIV-1 infection. Comprising tenofovir alafenamide (TAF) and emtricitabine, DESCOVY offers a potent, once-daily oral therapy option, distinguished by its improved safety profile compared to earlier formulations. As the landscape of HIV treatment evolves, understanding the market dynamics and projecting the financial trajectory of DESCOVY are essential for investors, healthcare stakeholders, and industry analysts.

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Market Overview and Product Positioning

The global HIV therapeutics market is projected to reach approximately USD 31 billion by 2026, driven by increasing prevalence, advanced treatment regimens, and expanding access in emerging markets [1]. Within this framework, DESCOVY occupies a significant segment owing to its efficacy and safety benefits. It was approved by the FDA in 2019 as part of a two-drug regimen for pre-exposure prophylaxis (PrEP) and HIV treatment, following the success of its predecessor, Truvada, which included tenofovir disoproxil fumarate (TDF).

DESCOVY’s positioning relies heavily on its safety profile—particularly its reduced renal toxicity and bone density impacts relative to TDF-based formulations [2]. This safety advantage has helped carve out a niche among clinicians wary of TDF’s long-term adverse effects, leading to increased adoption in both treatment and prevention contexts.

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Market Drivers

1. Growing HIV Prevalence: According to UNAIDS, approximately 38 million people globally live with HIV, and new infections persist at over 1.5 million annually [3]. The demand for effective, well-tolerated ART regimens remains high, fostering a favorable environment for DESCOVY.

2. Shift Toward TAF-based Regimens: The transition from TDF to TAF has been a significant driver. TAF’s improved safety profile has led to its recommendation as a preferred component in HIV treatment guidelines, augmenting sales of TAF-based drugs like DESCOVY [4].

3. Rising Uptake of PrEP: The CDC estimates that about 1.2 million Americans are indicated for PrEP, yet utilization remains suboptimal. Efforts to boost awareness and access, along with favorable safety profiles of drugs like DESCOVY, are expected to increase prescriptions [5].

4. Competitor Landscape: Major competitors include Gilead’s own Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), ViiV’s Tivicay and Juluca, and various generics entering the market. The competition has intensified but also underscores the robust market for novel, safer regimens.

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Market Challenges and Constraints

1. Patent Expirations and Generics: Gilead faces potential erosion of revenue from generic entrants. While DESCOVY’s primary patent protections extend into the late 2020s, patent cliffs for initial formulations pose long-term risks [6].

2. Pricing and Reimbursement: High drug prices, despite safety benefits, often face pushback from payers. Reimbursement policies influence market penetration, particularly in cost-sensitive regions.

3. Regulatory Developments: Approval processes and label expansions can either expand or limit a drug’s market. Any adverse regulatory rulings or safety concerns can impact sales adversely.

4. Market Penetration in Developing Countries: Limited access and infrastructure challenges continue to hinder large-scale adoption of advanced ARVs like DESCOVY in low-income settings, which comprise significant portions of the global HIV burden.

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Financial Trajectory and Revenue Outlook

Historical Performance: Since its launch in 2019, DESCOVY has demonstrated solid growth, driven largely by its expanding use in PrEP and treatment settings. Gilead reported that in 2022, HIV product revenues accounted for approximately 39% of total revenue, with DESCOVY’s contribution increasing alongside Biktarvy [7].

Forecasting Future Growth: The revenue projections hinge on several factors:

• Increased PrEP Adoption: Assuming a conservative annual growth rate of 10-12% in PrEP prescriptions worldwide, DESOVY is poised to benefit [8].

• Line Extension and New Indications: Gilead is pursuing label expansions for DESCOVY, including its use in pediatric populations and potential prophylactic indications, which could generate additional revenue streams [9].

• Market Share Dynamics: As Biktarvy consolidates its dominant position, DESCOVY’s share may stabilize or grow gradually with targeted marketing strategies and clinician preference for its safety profile.

• Impact of Generic Competition: Patent expirations projected around 2027–2028 could generate steep revenue declines unless Gilead counters with new formulations or indications.

Projected Revenue Trajectory: Analysts forecast that by 2025, DESCOVY could generate approximately USD 2.5–3 billion globally annually—assuming steady growth in both treatment and PrEP markets, primarily in North America and Europe, with emerging markets showing increasing adoption [10].

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Strategic Considerations for Stakeholders

• Innovation and Pipeline Expansion: Developing next-generation formulations or combinations can extend the lifecycle and maintain competitiveness.

• Market Expansion: Tailored strategies for emerging markets, including pricing negotiations and partnerships, are crucial.

• Regulatory Engagement: Timely extensions, label expansions, and safety updates can safeguard market share.

• Cost Management: Improving manufacturing efficiencies and negotiating favorable reimbursement terms can sustain profitability amid pricing pressures.

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Key Takeaways

• DESCOVY benefits from its safety profile, positioning it favorably in the competitive HIV therapeutics market.
• Market growth is driven by increasing HIV prevalence, evolving treatment guidelines favoring TAF-based regimens, and expanding PrEP use.
• Patent cliffs and generic competition pose notable risks, emphasizing the importance of innovation, pipeline development, and market diversification.
• Financially, DESCOVY is projected to sustain steady growth through 2025, with revenues possibly reaching up to USD 3 billion annually, contingent on global uptake rates.
• Stakeholders should prioritize strategic expansion, regulatory engagement, and pipeline innovation to capitalize on market opportunities.

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FAQs

1. How does DESCOVY differentiate itself from earlier HIV treatments?
DESCOVY offers a safer profile with reduced renal and bone density toxicity compared to TDF-based regimens, facilitating longer-term adherence and expanded use in diverse patient populations.

2. What are the primary markets driving DESCOVY sales?
The United States remains the largest market, followed by Europe and other high-income countries. Emerging markets are increasingly adopting TAF-based regimens, although factors like cost and healthcare infrastructure limit rapid expansion.

3. When are patent protections for DESCOVY expected to expire?
Patent protection is anticipated to last until approximately 2027–2028, after which generic manufacturers may introduce bioequivalent versions, potentially impacting Gilead’s revenue.

4. Can DESCOVY be used for HIV prevention (PrEP)?
Yes, in 2019, the FDA approved DESCOVY for PrEP, contributing significantly to its revenue prospects amidst growing PrEP awareness and utilization.

5. What future developments could influence DESCOVY’s market trajectory?
Potential label expansions, new formulations, combination therapies, and emergence of competitive products can all substantially alter its market share and financial outlook.

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References

[1] MarketsandMarkets. HIV Therapeutics Market Size and Forecast. 2022.

[2] Gilead Sciences. DESCOVY Prescribing Information. 2019.

[3] UNAIDS. Global HIV & AIDS statistics. 2022.

[4] Department of Health & Human Services. Guidelines for the Use of Antiretroviral Agents. 2022.

[5] CDC. PrEP in the United States. 2022.

[6] Gilead Sciences. Patent Portfolio and Intellectual Property. 2022.

[7] Gilead Sciences. Annual Report 2022.

[8] EvaluatePharma. HIV Market Forecasts. 2022.

[9] Gilead Sciences. Pipeline and Clinical Trials Updates. 2023.

[10] Bernstein Research. Pharmaceutical Sales Projections. 2023.