ODEFSEY Drug Patent Profile

Which patents cover Odefsey, and what generic alternatives are available?

Odefsey is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and thirty-two patent family members in fifty-eight countries.

The generic ingredient in ODEFSEY is emtricitabine; rilpivirine hydrochloride; 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; rilpivirine hydrochloride; tenofovir alafenamide fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Odefsey

Odefsey was eligible for patent challenges on November 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 15, 2033. This may change due to patent challenges or generic licensing.

There have been fifteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ODEFSEY

International Patents:	332
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	153
Drug Prices:	Drug price information for ODEFSEY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ODEFSEY
What excipients (inactive ingredients) are in ODEFSEY?	ODEFSEY excipients list
DailyMed Link:	ODEFSEY at DailyMed

See drug prices for ODEFSEY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ODEFSEY

Constraining patent/regulatory exclusivity:

8,754,065*PED

NDA:

208351

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.

Pharmacology for ODEFSEY

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

Paragraph IV (Patent) Challenges for ODEFSEY

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 ODEFSEY

ODEFSEY is protected by four US patents.

This potential generic entry date is based on patent 8,754,065.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	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
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

Expired US Patents for ODEFSEY

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	8,101,629
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	6,838,464
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	5,814,639*PED
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	7,067,522

International Patents for ODEFSEY

When does loss-of-exclusivity occur for ODEFSEY?

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 ODEFSEY around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	036387	DERIVADOS DE PIRIMIDINA, SU USO EN LA PREPARACION DE MEDICAMENTOS, COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN DICHOS COMPUESTOS, PROCEDIMIENTO PARA PREPARAR DICHAS COMPOSICIONES, PROCEDIMIENTOS PARA PREPARAR DICHOS COMPUESTOS, PRODUCTOS QUE CONTIENEN DICHOS COMPUESTOS, E INTERMEDIARIOS
Nicaragua	200700068	CLORHIDRATO DE 4-[[4-[[4-(2-CIANOETENIL)-2,6- DIMETILFENIL]AMINO]-2- PIRIMIDINIL]AMINO] BENZONITRILO
Croatia	P20040096	HIV INHIBITING PYRIMIDINES DERIVATIVES
China	100396785
Hong Kong	1026419
Canada	2481078	METHODE ET COMPOSITIONS POUR LA SYNTHESE DE BCH-189 ET DE COMPOSES APPARENTES (METHOD AND COMPOSITIONS FOR THE SYNTHESIS OF BCH-189 AND RELATED COMPOUNDS)

Supplementary Protection Certificates for ODEFSEY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1663240	132016000129162	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME UN SALE FARMACEUTICAMENTE ACCETTABILE DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, EMTRICITABINA, E TENOFOVIR ALAFENAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL TENOFOVIR ALAFENAMIDE EMIFUMARATO(ODEFSEY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1112, 20160623
1663240	CA 2015 00056	Denmark		PRODUCT NAME: CERTIFIKAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
1663240	PA2015037,C1663240-2	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, TENOFOVIRO, YPAC TENOFOVIRO DIZOPROKSILIO FUMARATO, IR EMTRICITABINODERINYS; REGISTRATION NO/DATE: EU/1/11/737/001 2011-11-28, EU/1/11/737/002 20111128
1419152	162 5010-2012	Slovakia		PRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
1663240	1690061-5	Sweden		PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Odefsey

Last updated: July 27, 2025

Introduction

Odefsey, a once-daily, single-tablet combination therapy containing rilpivirine, emtricitabine, and tenofovir alafenamide (TAF), has gained prominence in managing HIV-1 infection since its approval by the U.S. Food and Drug Administration (FDA) in 2016. Its simplified dosing, favorable safety profile, and efficacy have positioned it as a key player in the antiretroviral therapy (ART) market. Understanding the evolving market dynamics and financial trajectory of Odefsey involves analyzing its competitive landscape, regulatory environment, patient population trends, and payer considerations. This report consolidates current insights to inform stakeholders’ strategic decision-making.

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Market Landscape and Competitive Positioning

Overview of the HIV Therapeutic Market

The global HIV treatment market is projected to reach approximately $30 billion by 2027, driven by increasing diagnoses, lifelong treatment requirements, and advancements in ART regimes (1). Key players include Gilead Sciences, ViiV Healthcare, and Merck & Co., with compelling portfolios of fixed-dose combinations (FDCs), including Odefsey.

Odefsey’s Market Position

Odefsey has positioned itself as a preferred ART option owing to its potent efficacy, favorable side effect profile, and once-daily dosing. Its main competitors are Gilead’s Biktarvy (bictegravir/emtricitabine/TAF) and ViiV’s Triumeq (abacavir/dolutegravir/lamivudine). While Biktarvy leads sales volume due to its broader applicability to treatment-naïve and -experienced patients, Odefsey continues to retain market share among specific subgroups, particularly patients with baseline viral suppression or certain resistance profiles (2).

Patient Demographics and Prescriber Preferences

Odefsey’s core demographic includes adults with well-controlled HIV-1 infection, often those switching from other regimens due to tolerability issues or convenience factors. Prescriptions are heavily influenced by considerations regarding renal function and bone mineral density, as TAF-based regimens like Odefsey are associated with fewer renal and bone adverse effects compared to tenofovir disoproxil fumarate (TDF) counterparts.

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Regulatory and Clinical Developments

Regulatory Updates

Since its approval, Odefsey has received several updates, including expanded indications for use in treatment-experienced patients with virological suppression and approvals for populations with specific comorbidities. Ongoing clinical trials continue to explore its long-term efficacy and safety, bolstering clinician confidence and market stability.

Clinical Innovations and Label Extensions

Recent data underscores Odefsey's ability to maintain viral suppression with limited adverse events, encouraging clinician adoption. Its simplified regimen reduces pill burden, facilitating compliance, especially for adherent populations (3).

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Market Dynamics Influencing Financial Trajectory

Pricing Strategies and Reimbursement Policies

Odefsey’s pricing aligns with its status as a branded, high-efficacy medication. Its annual wholesale acquisition cost (WAC) remains competitive within the FDC segment, but with ongoing pressure from biosimilar developments and generics in related niches, pricing strategies must adapt. Payer negotiations, formulary placements, and drug tiering significantly influence net revenue.

Patent and Exclusivity Outlook

The drug's primary patent protection extends until 2029, after which it faces potential generic competition. Patent litigation, reformulation strategies, and patent extensions may extend market exclusivity, impacting the financial landscape.

Market Penetration and Adoption Rates

Annual prescription volumes reflect steady growth but face limitations from competition and treatment guidelines favoring other regimens for broad populations. However, niche adoption among patients intolerant of TDF-based therapies sustains steady revenue streams.

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Financial Trajectory Analysis

Revenue Forecasts and Growth Drivers

Considering current prescription trends, market penetration rates, and competitive stability, Odefsey’s revenue is projected to grow modestly at a compound annual growth rate (CAGR) of 3–5% over the next five years (4). Growth drivers include:

• Increased diagnosis and treatment initiation globally.
• Rising adoption in treatment-experienced and maintenance populations.
• Expansion into emerging markets with rising HIV prevalence.

Cost Dynamics

Production costs are expected to decrease gradually due to manufacturing efficiencies, while marketing and distribution expenses remain stable. Price erosion may occur as biosimilars or generics approach patent expiry, emphasizing the significance of remaining patent protections.

Potential Risks Impacting Financials

• Competitive shifts towards more potent or better-tolerated regimens.
• Regulatory hurdles or adverse clinical data.
• Policy changes affecting drug reimbursement and formulary inclusion.
• Patient adherence challenges influenced by side effect profiles or dosing complexities.

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Impact of COVID-19 on Market Dynamics

The COVID-19 pandemic initially disrupted the supply chain and delayed clinical trials. However, telemedicine expansion and the emphasis on simplified regimens have reinforced Odefsey’s market appeal. Moving forward, digital health solutions may further influence prescribing practices and adherence monitoring.

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Long-Term Outlook and Strategic Considerations

As patent expiry approaches, Gilead and partners are evaluating life-cycle management strategies, including reformulations or combination therapies designed to extend market exclusivity. Investment in clinical trials to demonstrate long-term safety and efficacy will underpin future value. Moreover, geographic expansion into underserved markets holds potential for revenue growth.

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Key Takeaways

• Odefsey retains a strategic niche in the HIV treatment market, supported by its efficacy, safety profile, and patient-friendly dosing.
• Competitive dynamics are primarily influenced by emerging regimens like Biktarvy and evolving treatment guidelines.
• Revenue growth is expected to be moderate, with a focus on maintaining market share pre-patent expiry.
• Price pressures, patent protections, and payer strategies will shape profitability trajectories.
• Long-term success hinges on innovation, geographic expansion, and strategic lifecycle management.

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FAQs

Q1: When is Odefsey expected to face generic competition?
A1: Generic competition is anticipated post-2029 when patent protections potentially expire, barring legal extensions or new formulations.

Q2: How does Odefsey compare to other antiretroviral therapies regarding safety?
A2: Odefsey’s TAF component offers a better renal and bone safety profile compared to TDF-based regimens, making it suitable for patients with renal or bone concerns.

Q3: What factors influence the prescribing patterns of Odefsey?
A3: Factors include patient comorbidities, prior treatment history, tolerability, convenience preferences, and formulary access.

Q4: How has the COVID-19 pandemic affected Odefsey’s market performance?
A4: The pandemic initially disrupted supply chains but also increased demand for simplified, long-acting regimens, bolstering Odefsey’s market position through telemedicine adoption.

Q5: What strategic moves can Gilead pursue to prolong Odefsey’s market relevance?
A5: Strategies include clinical trial data expansion, patent extensions, developing next-generation formulations, and expanding into new geographic markets.

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References

1. MarketWatch. "HIV Drugs Market Size & Trends." 2022.
2. IQVIA. "Pharmaceutical Market Reports." 2022.
3. Gilead Sciences Inc. "Odefsey Prescribing Information." 2016.
4. Evaluate Pharma. "HIV Market Forecast." 2022.