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-two patent family members in fifty countries.

The generic ingredient in DESCOVY is emtricitabine; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. Two suppliers are 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:	132
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	17
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
Chiang Mai University, Thailand	Phase 3
Ministry of Health, Thailand	Phase 3
Assistance Publique - Hôpitaux de Paris, FRANCE	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 one FDA Regulatory Exclusivity.

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	208215-001	Apr 4, 2016	AB	RX	Yes	Yes					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					Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No
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	208215-002	Jan 7, 2022		RX	Yes	No					Y

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
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

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
Bulgaria	107572
European Patent Office	1808434
European Patent Office	0984013	Activité antivirale et résolution de 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane (Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1, 3-oxathiolane)
Netherlands	300148
Russian Federation	2125558	METHOD OF SYNTHESIS OF 2',3'-DIDEOXY-3'-THIACYTYDINE OR 2',3'- -DIDEOXY-3'-THIA-5-FLUOROCYTIDINE, NUCLEOSIDE ENRICHED WITH ENANTIOMER, METHOD OF SYNTHESIS OF 1,3-OXATHIOLANE, METHOD OF SYNTHESIS OF 2-ACYLOXY-5-ACYLOXY-1,3-OXATHIOLANE ENRICHED WITH ENANTIOMER, ENANTIOMERS, METHOD OF CLEAVAGE OF NUCLEOSIDE ENANTIOMERS
South Korea	20140054068	TENOFOVIR ALAFENAMIDE HEMIFUMARATE

Supplementary Protection Certificates for DESCOVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1301519	132016000035069	Italy		PRODUCT NAME: TENOFOVIR ALAFENAMIDE O UN SUO SALE O UN SOLVATO DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123
1663240	15C0071	France		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1301519	1690012-8	Sweden		PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061/001-002 20151123
1301519	300803	Netherlands		PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123
0513200	C00513200/01	Switzerland		PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
1301519	CR 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 of Descovy

Introduction to Descovy

Descovy, a medication developed by Gilead Sciences, is a combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), used for the treatment of HIV-1 infection and as pre-exposure prophylaxis (PrEP) to prevent HIV infection. Here, we will delve into the market dynamics and financial trajectory of Descovy, highlighting its performance, market trends, and future outlook.

Market Position and Sales Performance

Recent Sales Figures

Descovy has shown significant growth in recent years. In the fourth quarter of 2023, Descovy sales decreased by 5% to $509 million compared to the same period in 2022, primarily due to unfavorable pricing dynamics in the United States, although this was partially offset by higher demand and channel inventory dynamics[2].

For the full year 2022, Descovy sales increased by 10% to $1.9 billion, driven by favorable pricing dynamics and higher demand. This growth was partially offset by inventory dynamics[5].

Comparative Market Share

In the context of PrEP, Descovy has gained substantial market share. By 2021, Descovy accounted for 46.7% of PrEP units dispensed in the commercial insurance market, up from 5.9% in 2019. This significant increase reflects a shift away from Truvada, another Gilead product, which saw its market share decline from 94.1% in 2019 to 53.3% in 2021[4].

Factors Influencing Sales

Pricing Dynamics

Pricing has been a critical factor influencing Descovy's sales. Favorable pricing dynamics have contributed to the increase in sales, while unfavorable pricing has led to declines. For instance, in the fourth quarter of 2023, unfavorable pricing dynamics in the US negatively impacted Descovy sales[2].

Demand and Channel Inventory

Higher demand and favorable channel inventory dynamics have also played a significant role in Descovy's sales performance. In 2022, higher demand and favorable pricing dynamics contributed to a 13% increase in Descovy sales for the fourth quarter compared to the same period in 2021[5].

Competition and Market Shifts

The HIV treatment market is highly competitive, with various regimens vying for market share. The rise of Biktarvy, another Gilead product, has impacted the sales of older regimens, including those based on TDF (tenofovir disoproxil fumarate) and TAF. However, Descovy has maintained its position due to its efficacy and the growing demand for PrEP[1].

Financial Impact on Gilead Sciences

Revenue Contribution

Descovy is a significant contributor to Gilead Sciences' revenue. For the full year 2022, Descovy sales of $1.9 billion were part of the overall HIV product sales, which increased by 5% to $17.2 billion compared to 2021[5].

Operating Expenses and Gross Margin

The financial performance of Descovy is also influenced by Gilead's overall operating expenses and gross margin. In the fourth quarter of 2023, Gilead's product gross margin was 70.4%, and non-GAAP product gross margin was 86.1%, reflecting changes in manufacturing strategy and product mix[2].

Market Trends and Future Outlook

Growing Demand for PrEP

The demand for PrEP is increasing, driven by awareness campaigns and expanded access to preventive care. This trend is expected to continue, benefiting Descovy and other PrEP medications. By 2021, Descovy accounted for nearly half of the commercial PrEP market, indicating strong potential for future growth[4].

Regulatory and Competitive Landscape

The regulatory environment and competitive landscape are crucial for Descovy's future. The loss of exclusivity for older products like Truvada has led to increased competition from generics, but Descovy's unique formulation and clinical benefits have helped it maintain market share. The approval of new HIV treatments, such as Biktarvy, also influences the market dynamics, but Descovy's position in the PrEP market remains strong[1][3].

Challenges and Opportunities

Pricing Pressures

Unfavorable pricing dynamics, particularly in the US, pose a challenge to Descovy's sales. Managing pricing strategies to balance revenue goals with market pressures will be essential for maintaining sales growth[2].

Expanding Access

Expanding access to Descovy, especially in regions with high HIV prevalence, presents a significant opportunity. Gilead's efforts to increase awareness and availability of PrEP can drive further growth for Descovy[4].

Key Takeaways

• Sales Performance: Descovy has shown significant growth, with a 10% increase in sales to $1.9 billion in 2022, driven by favorable pricing and higher demand.
• Market Share: Descovy has gained substantial market share in the PrEP market, accounting for nearly half of commercial PrEP units dispensed by 2021.
• Financial Impact: Descovy is a key contributor to Gilead Sciences' revenue, particularly within the HIV product segment.
• Market Trends: Growing demand for PrEP and favorable pricing dynamics are expected to continue driving Descovy's sales.
• Challenges and Opportunities: Managing pricing pressures and expanding access to Descovy are critical for its future growth.

FAQs

1. What is Descovy used for? Descovy is used for the treatment of HIV-1 infection and as pre-exposure prophylaxis (PrEP) to prevent HIV infection.

2. How has Descovy's sales performance been in recent years? Descovy sales increased by 10% to $1.9 billion in 2022, driven by favorable pricing and higher demand. However, in the fourth quarter of 2023, sales decreased by 5% due to unfavorable pricing dynamics.

3. What is the market share of Descovy in the PrEP market? By 2021, Descovy accounted for 46.7% of PrEP units dispensed in the commercial insurance market.

4. How does Descovy contribute to Gilead Sciences' revenue? Descovy is a significant contributor to Gilead Sciences' revenue, particularly within the HIV product segment, which increased by 5% to $17.2 billion in 2022.

5. What are the key challenges and opportunities for Descovy's future growth? Managing pricing pressures and expanding access to Descovy are critical for its future growth, given the growing demand for PrEP and the competitive landscape of the HIV treatment market.

Sources

1. DelveInsight: Changing Dynamics of HIV-1 Treatment Market.
2. Gilead Sciences: Fourth Quarter and Full Year 2023 Financial Results.
3. Gilead Sciences: Fourth Quarter and Full Year 2020 Financial Results.
4. West Health: Trends in HIV Preexposure Prophylaxis Utilization and Spending Among Individuals with Commercial Insurance.
5. Gilead Sciences: Fourth Quarter and Full Year 2022 Financial Results.