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 patent protection?

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

Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate has three hundred and thirty-two patent family members in fifty-eight countries.

One supplier is listed for this compound.

Summary for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE

International Patents:	332
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE

Constraining patent/regulatory exclusivity:

8,754,065*PED

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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		RX	Yes	Yes	8,754,065*PED				Y
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016		RX	Yes	Yes	7,390,791*PED				Y
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016		RX	Yes	Yes	7,125,879		Y	Y
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016		RX	Yes	Yes	9,296,769*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	7,125,879
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	7,803,788
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	7,067,522
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	6,703,396*PED

International Patents for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE

Country	Patent Number	Title	Estimated Expiration
Taiwan	201321396	Tenofovir alafenamide hemifumarate
Eurasian Patent Organization	201490208
Australia	2014271320
Japan	5247661
Iceland	2985
Australia	2001282941

Supplementary Protection Certificates for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3808743	PA2022515,C3808743	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA FARMACINIU POZIURIU PRIIMTINOS PRIDETINES RILPIVIRINO DRUSKOS, ISKAITANT RILPIVIRINO HIDROCHLORIDO RUGSTIES DRUSKA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	300767	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
1301519	11/2016	Austria		PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061/001-002 (MITTEILUNG) 20151123
3808743	CR 2022 00035	Denmark		PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER RILPIVIRINHYDROCHLORID, OG EMTRICITABIN; REG. NO/DATE: EU/1/11/737/001-002 20111128
1419152	CA 2012 00019	Denmark
1663240	132016000024751	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO E EMTRICITABINA(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128

Market Dynamics and Financial Trajectory for Emtricitabine, Rilpivirine Hydrochloride, and Tenofovir Alafenamide Fumarate

Last updated: July 30, 2025

Introduction

The global pharmaceutical landscape continues to evolve rapidly, driven by advancements in antiviral therapeutics, shifting regulatory frameworks, and increasing demand for effective HIV management. Central to this domain are the antiretroviral agents — emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide fumarate — which form the backbone of modern HIV treatment regimens. Understanding their market dynamics and financial trajectory is essential for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

This comprehensive analysis dissects the factors shaping the current and future market landscape of these drugs, examining their competitive positioning, regulatory influences, patent landscapes, and financial performance trajectories.

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Market Overview of Key Antiretroviral Agents

Emtricitabine

Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI), widely used as part of combination antiretroviral therapy (ART) for HIV-1. Its initial approval was granted by the FDA in 2003, and it has since become a cornerstone component in regimens such as Truvada and Descovy.

Market Penetration & Key Players:
Gilead Sciences remains dominant, controlling the primary formulations, with its robust pipeline and extensive patent estate. The drug's widespread adoption is bolstered by its well-established efficacy, safety profile, and inclusion in multiple fixed-dose combinations (FDCs).

Rilpivirine Hydrochloride

Rilpivirine is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), approved in 2011 for combination therapy in HIV-1 infections. Its advantage lies in improved resistance profiles and tolerability compared to earlier NNRTIs.

Market Dynamics:
Novartis and Janssen are notable stakeholders, with rilpivirine incorporated into multi-drug formulations like Complera and Juluca. Its role in treatment simplification and durability efforts enhances its market relevance.

Tenofovir Alafenamide Fumarate (TAF)

TAF, introduced in 2015, represents a significant advancement over tenofovir disoproxil fumarate (TDF) by offering similar efficacy with markedly reduced renal and bone toxicity. Its integration into various FDCs has driven rapid uptake.

Market Share & Evolution:
Gilead leads TAF formulations, with notable competitors entering through biosimilars and authorized generics. The drug’s favorable safety profile and broad applicability underpin its projected growth.

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Market Drivers

Technological Advancements & Formulation Innovations

The shift toward single-tablet regimens (STRs) has propelled market expansion. TAF’s superior safety and pharmacokinetic properties have facilitated its inclusion in numerous FDCs, improving patient adherence and treatment outcomes.

Regulatory Environment & Patent Expirations

Patent exclusivity provides temporary market monopoly protections, sustaining revenues for innovators like Gilead. However, impending patent cliffs, especially relating to TDF formulations, threaten imminent generic competition, prompting strategic shifts toward formulation renewal and combination therapies.

Global HIV Burden & Treatment Access

The World Health Organization (WHO) estimates approximately 38 million people living with HIV globally (2022 data). Access disparities, especially in low- and middle-income countries, influence market dynamics, with generic manufacturers expanding presence in these regions, driving volume but exerting downward price pressures.

Pricing & Reimbursement Policies

The push for lower-cost HIV drugs in emerging markets influences pricing strategies. Developed markets benefit from reimbursement frameworks that favor innovative, safer formulations like TAF-based products.

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Competitive Landscape and Patent Strategies

Patent Holdings & Challenges:
Gilead, as the primary patent owner for many formulations, has employed a complex patent strategy, including secondary method-of-use patents and formulation patents, delaying biosimilar entry [1].

Biosimilar & Generic Competition:
As patent protections expire, generic companies target older TDF products, while innovator firms pivot to newer, patent-protected TAF formulations. Regulatory hurdles in developing bioequivalent generics pose barriers, but market entry is imminent in many regions, compressing profit margins.

Strategic Alliances & Licensing:
Partnerships between major pharma companies and regional manufacturers facilitate accelerated access, especially in low-resource settings, influencing global market share distribution.

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Financial Trajectory & Market Forecast

Historical Revenue Performance

• Gilead Sciences: Dominates with multi-billion dollar revenues from combination therapies involving TAF and emtricitabine (e.g., Descovy).
• Market Trends: Steady growth seen in TAF formulations post-2015, with CAGR estimates exceeding 10% over the last 5 years.

Projected Market Growth (2023-2030)

• Estimates: The antiretroviral drug market is projected to reach approximately USD 23 billion by 2030, with TAF-based products comprising over 60% of this figure, owing to their safety advantage and formulation versatility.
• Drivers for Growth: Increasing early diagnosis, expanding ART coverage, and formulation innovations will sustain demand. The Asia-Pacific region, notably China, India, and Southeast Asia, is expected to see the fastest growth, driven by high HIV prevalence and price-sensitive markets.

Impact of Patent Expirations

Patent cliffs in key markets will intensify competition, potentially lowering prices and compressing profit margins. Innovators are investing heavily in next-generation formulations—long-acting injectables and combination therapies—to mitigate revenue erosion.

Emerging Opportunities

Development of generic TAF formulations, biosimilars, and innovative delivery mechanisms positions companies to capture emerging market segments. There is notable interest in long-acting injectable formulations (e.g., cabotegravir/rilpivirine), which may redefine revenue streams post-2025.

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Regulatory & Market Challenges

• Regulatory Hurdles: Biosimilar approval pathways differ globally, with stringent requirements in the US and Europe, potentially delaying market entry.
• Pricing & Negotiation Dynamics: Governments and payers are increasingly demanding price reductions and value-based pricing, impacting revenue growth.
• Resistance & Treatment Efficacy: Viral resistance patterns necessitate continual drug development and surveillance, influencing portfolio sustainability.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Focus on innovation—long-acting formulations, novel delivery systems, and enhanced safety profiles—to sustain market share.
• Investors: Monitor patent filings, pipeline developments, and regional market entries for growth opportunities and risk mitigation.
• Healthcare Providers: Advocate for regimens with optimal safety and adherence profiles, emphasizing the importance of newer formulations like TAF-based products.

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Key Takeaways

• The HIV antiretroviral market is exponential, predominantly driven by TAF-based formulations due to superior safety profiles and formulation flexibility.
• Patent protections are crucial for revenue streams; however, imminent patent expirations signal increased generic competition, pressuring prices and margins.
• Innovation in long-acting injectables and combination therapies presents lucrative growth opportunities, offsetting patent cliffs.
• Emerging markets and regions with high HIV prevalence will dominate volume growth, but price sensitivity necessitates strategic tiered pricing models.
• Stakeholders must balance innovation, patent protection, regulatory navigation, and competitive pricing to optimize market share and financial performance.

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FAQs

1. How will patent expirations impact the revenues of emtricitabine, rilpivirine, and TAF?
Patent expirations will open the markets to generic biosimilars and formulations, leading to significant price reductions and potential revenue declines for brand-name manufacturers. Companies can counter this by innovating with new formulations or delivery mechanisms.

2. Which regions are the key growth markets for these drugs?
Emerging markets in Africa, Asia-Pacific, and Latin America present the highest growth potential due to increasing HIV prevalence and demand for affordable treatments, although regulatory and pricing challenges exist.

3. What are the main drivers sustaining the growth of TAF-based therapies?
The safety profile, improved renal and bone health outcomes, and the convenience of single-tablet regimens prevent treatment fatigue and improve adherence, supporting sustained growth.

4. How is the competition evolving with long-acting injectable formulations?
Long-acting injectables, such as cabotegravir and rilpivirine, are poised to reshape the market by offering monthly or quarterly dosing options, appealing to non-adherent patients, thus potentially diverting revenue from oral regimens.

5. What strategic approaches can companies adopt to navigate patent cliffs and biosimilar entry?
Diversification into next-generation formulations, strong patent portfolios, strategic licensing, and regional market exclusivity can help firms sustain revenues amid rising biosimilar competition.

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References

[1] Gilead Sciences Patent Portfolio Analysis, 2022.
[2] WHO HIV Treatment Guidelines, 2022.
[3] IBISWorld Global HIV Antiretroviral Market Report, 2023.
[4] IQVIA HIV Market Data, 2022.
[5] MarketWatch Antiretroviral Drug Market Forecast, 2023.