Emtricitabine; tenofovir alafenamide fumarate - Generic Drug Details

What are the generic sources for emtricitabine; tenofovir alafenamide fumarate and what is the scope of freedom to operate?

Emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc, Apotex, and Lupin Ltd, and is included in three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Emtricitabine; tenofovir alafenamide fumarate has fifty-eight patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for emtricitabine; tenofovir alafenamide fumarate

International Patents:	58
US Patents:	2
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Clinical Trials:	45
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for emtricitabine; tenofovir alafenamide fumarate
DailyMed Link:	emtricitabine; tenofovir alafenamide fumarate at DailyMed

Recent Clinical Trials for emtricitabine; tenofovir alafenamide fumarate

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

Sponsor	Phase
Jos Antonio Mata Marn	PHASE3
Instituto Mexicano del Seguro Social	PHASE3
Shanghai Public Health Clinical Center	NA

See all emtricitabine; tenofovir alafenamide fumarate clinical trials

Pharmacology for emtricitabine; tenofovir alafenamide fumarate

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

Anatomical Therapeutic Chemical (ATC) Classes for emtricitabine; tenofovir alafenamide fumarate

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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 emtricitabine; tenofovir alafenamide fumarate

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
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
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No	8,754,065*PED				Y
Apotex	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	214053-002	May 17, 2024		DISCN	No	No
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	AB	RX	Yes	Yes	8,754,065*PED				Y
Lupin Ltd	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	213926-001	Dec 13, 2024	AB	RX	No	No

Expired US Patents for emtricitabine; tenofovir alafenamide fumarate

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	5,914,331*PED
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	7,803,788
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	6,642,245*PED

International Patents for emtricitabine; tenofovir alafenamide fumarate

Country	Patent Number	Title	Estimated Expiration
Ecuador	SP14013206
Slovenia	2744810
Taiwan	I516499
Lithuania	2744810
Portugal	2744810
Denmark	2744810
Colombia	6880063

Supplementary Protection Certificates for emtricitabine; tenofovir alafenamide fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1632232	300852	Netherlands		PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
3808743	CA 2022 00035	Denmark		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. 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
3808743	LUC00275	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU D'UNE FORME THERAPEUTIQUEMENT EQUIVALENTE DE CELLE-CI PROTEGEE PAR LE BREVET DE BASE, TELLE QU'UN SEL D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE, ET D'EMTRICITABINE; AUTHORISATION NUMBER AND DATE: EU/1/11/737/001-002 20111128
1663240	1590057-4	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICAL LY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128
0915894	08C0020	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
1663240	1590055-8	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLYACCEPTABLE SALT OF RILPIVIRINE, INICLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128

Emtricitabine; tenofovir alafenamide fumarate Market Analysis and Financial Projection

Last updated: February 15, 2026

What is the current market landscape for emtricitabine and tenofovir alafenamide fumarate?

Emtricitabine and tenofovir alafenamide fumarate are antiretroviral agents used to treat HIV-1 infection and pre-exposure prophylaxis (PrEP). Combined, these drugs are central to HIV therapeutic regimens, especially with the approval of fixed-dose combinations like Genvoya and Descovy. The global market for these drugs is expanding, driven by increasing HIV prevalence, awareness campaigns, and approvals for PrEP in multiple jurisdictions.

The market value in 2022 is estimated at roughly $6 billion, with projections to reach over $9 billion by 2028, growing at a compound annual growth rate (CAGR) of approximately 7%[1].

How does the production and patent landscape influence market dynamics?

Patent expiration: Multiple formulations face patent cliffs between 2023 and 2027, enabling generic manufacturers to enter markets in the US, Europe, and emerging economies. For example, Gilead Sciences’ patents on Truvada and Descovy expire in the US in 2026[2].

Generic competition: Entry of generics reduces prices, increasing access but shrinking market share for brand-name products. Prices of generics can decrease by 60-80% within two years of patent expiry[3].

Manufacturing capacity: Advances in synthesis produce more cost-effective active pharmaceutical ingredients (APIs), lowering production costs for both originator and generic companies.

What are the key factors shaping future revenue streams?

Regulatory Approvals and Usage Expansion

• Pre-exposure prophylaxis (PrEP): Increasing adoption in high-risk populations in the US, Europe, and Asia-Pacific boosts revenue. In 2022, approximately 900,000 individuals globally used PrEP, with steady growth[4].

• New indications: Ongoing clinical trials exploring use in hepatitis B (HBV) and HIV cure strategies could create additional markets.

Pricing and Market Penetration Strategies

• Price reductions: To maintain competitiveness post-patent expiry, companies deploy tiered pricing, discounts, and patient assistance programs.

• Market access efforts: Expanding into emerging markets like India and Africa involves navigating local regulatory pathways and pricing regulations, often resulting in lower prices but broader access.

Competitive Landscape

• Emerging alternatives: New drugs such as islatravir and other long-acting injectables offer alternative options. Their approval timelines influence market share shifts[5].

• Combination therapies: Fixed-dose combinations enhance adherence and streamline treatment, favoring established products with proven safety profiles.

What are the risks and opportunities for stakeholders?

Risks

• Patent expiries diminish revenue potential in mature markets.
• Development of novel ARV agents could reduce reliance on existing drugs.
• Regulatory changes in pricing policies or approval processes may influence market entry.

Opportunities

• Expansion of PrEP programs in underserved regions can increase demand.
• Development of longer-acting formulations may transform treatment paradigms.
• Biosimilar development provides options for cost containment and market diversification.

How do financial projections reflect long-term trends?

Based on current growth rates and patent landscapes, revenue from emtricitabine and tenofovir alafenamide fumarate is expected to experience a plateau around 2028, barring significant innovations or market expansion. Generics will significantly cut revenues in developed markets post-2026 but can stimulate sales volumes in emerging markets where prices are lower.

Investors should consider:

• The impact of patent cliffs on revenues.
• The pipeline of long-acting formulations and new indications.
• Regional regulatory and pricing environments.

Key Takeaways

• The global market for emtricitabine and tenofovir alafenamide fumarate is projected to grow at a CAGR of 7% until 2028.
• Patent expiries from 2023 onward will drive generic entry, significantly reducing prices and revenues in mature markets.
• Expanding PrEP programs and new product formulations are the main growth drivers.
• Competition from new drugs and long-acting injectables pose mid-term threats.
• Strategic focus on emerging markets, biosimilars, and pipeline innovations can offset patent-related revenue declines.

FAQs

1. What factors most influence pricing in the emtricitabine and tenofovir alafenamide fumarate market?
Patent status, regional drug approval processes, market competition, and manufacturing costs are primary drivers of pricing dynamics.

2. How does the patent landscape affect market share?
Patent expiries in key jurisdictions enable generics, decreasing brand-name market share and prices. Strategic patent extensions and formulations can delay generic entry.

3. What are the notable pipeline developments?
Long-acting injectable formulations and drugs with added indications for HBV or HIV cure are in advanced stages, potentially transforming treatment.

4. How do regional healthcare policies impact market growth?
Government initiatives for HIV/AIDS prevention, PrEP inclusion in public health programs, and pricing regulations influence adoption and sales volumes.

5. What are the key regulatory challenges?
Approval delays for new indications or formulations, safety profile requirements, and pricing negotiations can slow market expansion or reduce profitability.

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Sources
[1] MarketWatch, "Antiretroviral Drugs Market Size," 2022.
[2] Gilead Sciences, Patent Portfolio & Market Exclusivity Data, 2022.
[3] IQVIA, "Generic Drug Market Trends," 2021.
[4] UNAIDS, "PrEP Global Report," 2022.
[5] FDA & EMA approvals, 2022.