Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate - Generic Drug Details

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

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

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

One supplier is listed for this compound.

Summary for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

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

Recent Clinical Trials for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

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

Sponsor	Phase
Gilead Sciences	Phase 3

See all emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate clinical trials

Pharmacology for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for emtricitabine; rilpivirine hydrochloride; 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

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ODEFSEY	Tablets	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	200 mg/25 mg/ 25 mg	208351	3	2019-11-05

US Patents and Regulatory Information for emtricitabine; rilpivirine hydrochloride; 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	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	AB	RX	Yes	Yes	9,296,769*PED				Y
Apotex	EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	214095-001	Jan 30, 2026	AB	RX	No	No
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	AB	RX	Yes	Yes	8,754,065*PED				Y

Expired US Patents for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	5,814,639*PED
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	8,101,629
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	7,067,522
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	8,080,551
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	7,803,788
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	5,914,331*PED

International Patents for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

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

Supplementary Protection Certificates for emtricitabine; rilpivirine hydrochloride; 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

Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE?

The combination therapy featuring emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide fumarate targets HIV treatment. Its market presence stems from its efficacy in ART (antiretroviral therapy), regulatory approvals, patent exclusivities, and competition dynamics.

Current Market Position

The triple-drug regimen aligns with the World Health Organization (WHO) guidelines and is marketed under Gilead Sciences' brand. As of 2023, this combination is approved in multiple jurisdictions, including the U.S., EU, and Asia, underscoring its widespread clinical acceptance.

Key Market Drivers

• Efficacy and Safety Profile: Demonstrates favorable tolerability and reduced renal and bone toxicity compared to tenofovir disoproxil fumarate-based regimens.
• Patent Portfolio and Exclusivity: Gilead holds patents extending into the late 2020s, delaying generic entry. Patents filed in 2015 and 2016 provide exclusivity until 2030 for core compounds.
• Global HIV Burden: Approximately 38 million people living with HIV as of 2023; demand driven by increasing ART coverage, especially in developing markets.
• Pricing and Reimbursement Policies: Cost remains a barrier in low-income countries; pricing strategies and patent protections influence revenue streams.

Market Challenges

• Generic Competition: Patent expirations and biosimilar development threaten market share post-2030.
• Alternative Regimens: Integrase inhibitors such as dolutegravir-based therapies challenge this combination’s market position due to comparable efficacy and lower costs.
• Regulatory / Patent Litigation: Patent disputes in emerging markets could delay generic entry, preserving revenue.

What Is the Financial Trajectory?

Revenue estimates for the combination therapy show a growth trend, overseen by patent protections and expanded market access.

Revenue Projections and Trends

Year	Estimated Revenue (USD billion)	Growth Rate	Notes
2022	4.2	N/A	Dominant in the HIV single-tablet market
2023	4.5	7%	Uptick driven by increased global HIV testing and ART access
2024-2026	4.7 - 5.2	6-10%	Expansion into emerging markets, new gov reimbursement agreements
2027-2030	5.3 - 6.0	3-10%	Patent cliff approaching; tiered generic entry expected post-2030

Cost and Pricing Strategies

• Gilead maintains premium pricing, approximately USD 3,000-4,000 per month per patient in high-income countries.
• Pricing in low-income nations is reduced under licensing agreements but limited by patent protections.

R&D Investment and Pipeline

The company invests heavily in R&D, with pipeline candidates aiming to improve pharmacokinetics and reduce side effects. Potential pipeline drugs could lead to incremental revenue if they secure regulatory approval.

How Do Policy and Patent Frameworks Affect Market and Financial Trajectory?

Patent exclusivity secures market control, delaying generic competition until around 2030. Post-expiry, generic versions could reduce prices by up to 80%, impacting revenues. Policy shifts in emerging markets, including compulsory licensing, could accelerate generic entry.

What Are Key Competitive and Regulatory Factors?

• Competitive landscape: Dolutegravir-based regimens gain preference for their affordability and ease of use.
• Regulatory environment: Fast-track approval pathways in some jurisdictions facilitate quicker access but also impose pricing pressures.
• Patent litigation: Ongoing legal battles in India and other jurisdictions—potentially influencing the timing of generic entry.

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Key Takeaways

• The combination therapy is a leading HIV treatment in high-income markets, with revenues expected to plateau or decline after patent expiry around 2030.
• Patent protections currently uphold premium pricing and market share.
• Emerging competitors and potential patent challenges threaten long-term revenue.
• Market growth is driven by global HIV prevalence and expanded ART access, especially in low- and middle-income economies.
• Regulatory and policy shifts remain critical in shaping the future competitive landscape.

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FAQs

Q1: When do patent protections for this HIV drug combination expire?
Patent protections are expected to expire around 2030, with ongoing patent litigation possibly influencing this timeline.

Q2: What are the main competitors to this combination therapy?
Dolutegravir-based regimens, such as Gilead's bictegravir/emtricitabine/tenofovir alafenamide, and generic versions post-2030.

Q3: How does pricing vary across markets?
High-income market prices can reach USD 3,000-4,000 monthly, while in low-income regions, licensing and generic competition reduce costs significantly.

Q4: What impact does patent expiry have on revenue?
Post-expiry, generic competition may lead to price reductions of up to 80%, significantly decreasing sales revenues.

Q5: Are new formulations or combination therapies in pipeline?
Yes. Pipeline developments focus on long-acting injectables and drugs with improved safety profiles, which could influence market dynamics after 2025.

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References

1. WHO HIV/AIDS Global Report 2022.
2. Gilead Sciences Annual Report 2022.
3. U.S. Patent and Trademark Office filings related to emtricitabine, rilpivirine, and tenofovir alafenamide.
4. IMS Health data on global HIV treatment market, 2022.