DESCOVY Drug Patent Profile

Which patents cover Descovy, 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
Gilead Sciences	Phase 3
ANRS, Emerging Infectious Diseases	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					Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	AB	RX	Yes	Yes					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
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016

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
Australia	1367692
European Patent Office	1808434
Australia	2012296622

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	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
1301519	CA 2016 00012	Denmark		PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123

Market Dynamics and Financial Trajectory for DESCOVY: An In-Depth Analysis

Last updated: December 28, 2025

Summary

DESCOVY (emtricitabine/tenofovir alafenamide) stands as a prominent HIV-1 treatment with a favorable safety profile compared to its predecessor, Truvada. This analysis explores the evolving market landscape, competitive positioning, regulatory status, sales performance, and future growth prospects of DESCOVY. Leveraging recent data, industry trends, and policy insights, this report provides a comprehensive view suitable for investors, healthcare executives, and strategic planners.

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What Are the Market Dynamics Surrounding DESCOVY?

How Has the HIV Treatment Market Evolved in Recent Years?

The global HIV therapeutics market, valued at approximately $21.8 billion in 2022, is projected to reach $34.7 billion by 2030, expanding at a CAGR of roughly 6%[1]. The increasing prevalence of HIV, particularly in underserved markets, alongside innovations in antiretroviral therapy (ART), fuels this growth.

Key Drivers:

• Rising HIV Incidence: According to UNAIDS, there were approximately 38 million people living with HIV globally in 2022, with new infections persisting, particularly in regions like Sub-Saharan Africa.
• Shift Toward Simplified Regimens: Patients and providers favor once-daily, combination pills with minimal side effects.
• Expanding Use of Pre-Exposure Prophylaxis (PrEP): Growing awareness and approval of PrEP prevent new infections, indirectly supporting pharmaceutical sales.

What Is the Position of DESCOVY in the Competitive Landscape?

DESCOVY, introduced in 2019, is positioned as a safer alternative to Truvada, primarily distinguished by:

• Reduced Renal and Bone Toxicity: Due to the tenofovir alafenamide (TAF) formulation, which lower the renal and bone mineral density risks.
• Indication Expansion: Approved for both HIV-1 treatment and PrEP.

Major Competitors:

Drug Name	Active Ingredients	Market Share (2022)	Notable Features
DESCOVY	Emtricitabine / TAF	~25%	Improved safety profile
Truvada	Emtricitabine / TDF	~60%	Established, broader label indications
Biktarvy	Bictegravir / Emtricitabine / TAF	~10%	All-in-one, high efficacy
Dovato	Dolutegravir / Lamivudine	~5%	Simplified two-drug regimen

Source: IQVIA, 2022.

How Have Regulatory and Policy Changes Affected DESCOVY?

• FDA Approvals: In 2019, the FDA approved DESCOVY for HIV-1 treatment and pre-exposure prophylaxis (PrEP).
• WHO Guidelines: Support the use of TAF-based regimens for PrEP, but WHO still recommends TDF-based options for certain populations, influencing market adoption.
• Pricing & Reimbursement: Payers increasingly favor TAF over TDF due to safety advantages, but cost considerations influence prescribing behaviors.

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What Is the Financial Trajectory for DESCOVY?

How Have Sales Evolved Since Launch?

Year	Estimated Global Sales (USD millions)	Key Market Highlights
2019	$150 million	Launch year, rapid uptake
2020	$300 million	Expanded indications, increased adoption
2021	$420 million	Growth driven by PrEP and treatment use
2022	$470 million	Plateau nearing saturation in key markets

Notes:

• Sales growth reflects increased utilization for both treatment and PrEP indications.
• Market penetration remains strong in North America, with emerging markets in Europe and Asia-Pacific showing rising adoption.

What Are the Financial Drivers and Risks?

Driver / Risk	Details
Market Expansion	Growing global awareness and access improve sales prospects
Pricing Strategies	Competitive pricing and rebates influence revenue margins
Patent Expirations	Patent expiry of DESCOVY's key formulations is anticipated around 2028, risking generic erosion
Regulatory Changes	Restrictions on PrEP in certain regions may limit growth
Competition	Emergence of novel agents and fixed-dose combinations could impact market share

How Will Patent Expiry and Generic Competition Affect Revenue?

Patent expiration, expected in 2028, may lead to generics entering markets like the US and Europe, potentially reducing revenue by up to 80% over subsequent years, based on typical generic market erosion scenarios[2].

What Are Future Growth Opportunities?

• Expanding PrEP Access in Emerging Markets: Growing awareness campaigns and subsidized pricing enhance adoption.
• New Indications: Potential for DESCOVY to be explored in additional viral or co-infection contexts.
• Combo Regimens: Integration into all-in-one pills enhances adherence and market share.

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How Do Policy and Reimbursement Factors Shape DESCOVY's Market Trajectory?

Policy Aspect	Impact on DESCOVY	Current Status
Reimbursement	Favorable for TAF-based regimens	Increasing coverage in developed markets
Pricing Policies	Push for competitive pricing to maximize access	Price negotiations ongoing
Generic Entry Policies	Accelerate access post-patent expiry	Evolving, with stricter regulation in some regions

Comparative Analysis: DESCOVY vs. Competitors

Aspect	DESCOVY	Truvada	Biktarvy	Dovato
Formulation	Emtricitabine + TAF	Emtricitabine + TDF	Bictegravir + Emtricitabine + TAF	Dolutegravir + Lamivudine
Safety Profile	Excellent (renal/bone)	Good but riskier	Excellent	Good
Indications	HIV treatment & PrEP	HIV treatment & PrEP	HIV treatment	HIV treatment
Market Share (2022)	~25%	~60%	~10%	~5%
Patent Expiry	Expected 2028	2028	2028	2028

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Deep Dive: Future Outlook and Strategic Considerations

Influx of Generics and Pricing Pressures

Post-patent expiry, the entry of generics could precipitate pricing declines. Manufacturers will need to differentiate DESCOVY via:

• Brand loyalty
• Enhanced safety profiles
• Expanded indications

Role of Biosimilars and Innovative Regimens

While biosimilars are less relevant to small molecule drugs like DESCOVY, the emergence of novel combination therapies (e.g., long-acting injectables) presents a competitive challenge exploring new treatment paradigms.

Global Access and Equity

Efforts by Gilead Sciences to license DESCOVY in low- and middle-income countries could unlock additional markets, supporting revenue growth despite impending patent cliffs.

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Concluding Remarks: What Are the Key Takeaways?

• Market Positioning: DESCOVY benefits from its improved safety profile and expanding indications, positioning it well in a competitive HIV therapeutics market.
• Financial Outlook: Sales are trending upward through 2022 but face future decline due to patent expiration, with potential for renewed growth if new indications or formulations emerge.
• Regulatory & Policy Influence: Reimbursement policies favor TAF-based drugs, bolstering DESCOVY's adoption.
• Competitive Risks: Patent expiry in 2028 invites generic entry, necessitating strategic differentiation.
• Growth Opportunities: Increasing global PrEP access and potential new indications remain significant growth vectors.

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Frequently Asked Questions (FAQs)

1. When is DESCOVY’s patent set to expire, and how will this impact sales?
Patent protection is expected to expire around 2028, which could lead to significant generic competition and a potential decline in revenues by 50-80% over subsequent years unless strategies for differentiation or new indications are implemented.

2. How does DESCOVY compare to Truvada in terms of safety and efficacy?
DESCOVY employs TAF, which offers a better safety profile with reduced renal and bone mineral density risks compared to TDF-based Truvada, while maintaining comparable efficacy for HIV treatment and PrEP.

3. What market segments are driving DESCOVY sales?
Primarily North America, with significant contributions from HIV treatment and PrEP segments. Emerging markets in Europe and Asia also contribute as awareness and access increase.

4. Are there any upcoming approvals or indications that could boost DESCOVY’s market?
Potential expansion into other co-infections (e.g., hepatitis B) or longer-acting formulations could foster growth, pending regulatory approvals.

5. How does global policy influence DESCOVY’s adoption?
Favorable policies in developed countries promote access and reimbursement, while regions with restrictive policies may delay or limit usage, impacting sales trajectories.

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References

[1] Global HIV Therapeutics Market Report, 2023. MarketWatch.
[2] IQVIA, 2022. "Pharmaceutical Market Trends and Patent Data."
[3] WHO Guidelines on HIV Treatment and PrEP, 2021.
[4] Gilead Sciences. Strategic filings and patent timelines, 2023.

Note: Data and projections are based on recent industry reports and may evolve with market and regulatory developments.