ODEFSEY Drug Patent Profile

When do Odefsey patents expire, and when can generic versions of Odefsey launch?

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

This drug has fifty-eight patent family members in forty-two 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.

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:	58
US Patents:	2
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

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 two US patents.

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	8,754,065*PED				Y
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

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	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

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
Japan	2014528924
Canada	2398887	2,4,DI-(HETERO-) ARYLAMINO (-OXY)-5 PYRIMIDINES SUBSTITUTEESUTILISEES COMME AGENTS ANTINEOPLASIQUES (2,4,DI(HETERO-)ARYLAMINO(-OXY)-5-SUBSTITUTED PYRIMIDINES AS ANTINEOPLASTIC AGENTS)
South Korea	20110132475	피리미딘 함유 ＮＮＲＴＩ와 ＲＴ 저해제의 배합물 (COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS)
Eurasian Patent Organization	200700536	ГИДРОХЛОРИД 4-[[4-[[4-(2-ЦИАНОЭТЕНИЛ)-2,6-ДИМЕТИЛФЕНИЛ]АМИНО]-2-ПИРИМИДИНИЛ]АМИНО]БЕНЗОНИТРИЛА

Supplementary Protection Certificates for ODEFSEY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	C20150039 00166	Estonia		PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA EMTRITSITABIINI;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
0513200	91073	Luxembourg		91073, EXPIRES: 20160131
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
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

ODEFSEY (GL-7734) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

ODEFSEY (GL-7734) is a nucleoside analog reverse transcriptase inhibitor (NRTI) approved for the treatment of chronic hepatitis C virus (HCV) infection. The drug's market penetration and financial performance are influenced by its efficacy, safety profile, pricing, competition, and regulatory landscape.

What is ODEFSEY's Approved Indication and Mechanism of Action?

ODEFSEY is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 4, 5, or 6 infection, without cirrhosis or with compensated cirrhosis. It is a fixed-dose combination of sofosbuvir 400 mg and ledipasvir 94 mg.

The mechanism of action involves both components. Sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B RNA-dependent RNA polymerase, an enzyme essential for viral replication. Ledipasvir inhibits the HCV NS5A protein, which is critical for viral RNA replication, assembly, and release. This dual mechanism targets key steps in the HCV life cycle, leading to viral suppression [1].

What is ODEFSEY's Clinical Efficacy and Safety Profile?

Clinical trials have demonstrated high sustained virologic response (SVR) rates for ODEFSEY across different HCV genotypes and patient populations.

Key Efficacy Data:

• HCV Genotype 1: In the ION-1 study, ODEFSEY (ledipasvir/sofosbuvir) with or without ribavirin achieved SVR12 rates of 94% to 99% in treatment-naive and treatment-experienced patients with genotype 1 HCV, without cirrhosis [2].
• HCV Genotypes 4, 5, 6: The ION-4 study showed ODEFSEY achieved SVR12 rates of 97% in treatment-naive and treatment-experienced patients with genotype 4 HCV, without cirrhosis [3]. Data for genotypes 5 and 6, while less extensive, also indicate high efficacy [4].
• Patients with Compensated Cirrhosis: ODEFSEY administered for 12 or 24 weeks demonstrated high SVR12 rates (up to 96%) in patients with genotype 1 HCV and compensated cirrhosis, though longer treatment duration was sometimes recommended [5].

Safety Profile:

ODEFSEY is generally well-tolerated. Common adverse events observed in clinical trials include fatigue, headache, nausea, and insomnia. The incidence of serious adverse events is low.

• Most Common Adverse Events (incidence ≥ 5%):
  • Fatigue
  • Headache
  • Nausea
  • Diarrhea
  • Insomnia
  • Anemia (when used with ribavirin)
• Serious Adverse Events: Rare cases of bradycardia have been reported, particularly when ODEFSEY is co-administered with amiodarone [1].

What is ODEFSEY's Market Positioning and Competitive Landscape?

ODEFSEY entered a rapidly evolving market for direct-acting antiviral (DAA) agents for HCV. Its positioning is defined by its efficacy, safety, and fixed-dose combination formulation, simplifying treatment regimens.

Key Competitors:

The competitive landscape for ODEFSEY includes other DAA regimens, primarily targeting the same HCV genotypes. These include:

• Harvoni (ledipasvir/sofosbuvir): Also developed by Gilead Sciences, Harvoni was one of the first pan-genotypic DAAs and a direct predecessor to ODEFSEY, offering a similar mechanism with a slightly different ledipasvir dose in some formulations.
• Viekira Pak (ombitasvir/paritaprevir/ritonavir + dasabuvir): A combination regimen approved for genotype 1 HCV, requiring multiple pills and specific dosing instructions.
• Zepatier (elbasvir/grazoprevir): Developed by Merck, Zepatier is approved for genotypes 1 and 4 and offers a pan-genotypic option.
• Epclusa (sofosbuvir/velpatasvir): Another Gilead Sciences product, Epclusa is a pan-genotypic DAA approved for all HCV genotypes (1-6) and is a key competitor, especially for broader genotype coverage.
• Mavyret (glecaprevir/pibrentasvir): Developed by AbbVie, Mavyret is a pangenotypic DAA with a short treatment duration option, making it a significant competitor.

ODEFSEY's competitive advantage lies in its established efficacy and a simplified pill burden (one tablet once daily) compared to older interferon-based therapies and some early DAA combinations. However, newer pan-genotypic options like Epclusa and Mavyret offer broader genotype coverage and in some cases, shorter treatment durations, posing significant competitive pressure.

What is ODEFSEY's Pricing Strategy and Reimbursement Landscape?

The pricing of ODEFSEY, like other DAAs, has been a subject of significant debate. The initial list price reflected the substantial R&D investment and the perceived value in curing a chronic, debilitating disease.

Pricing:

• List Price: The list price for a 12-week course of ODEFSEY has historically been in the range of \$90,000 to \$100,000 in the United States [6].
• Net Price: Actual prices paid by payers (governments, insurers) are significantly lower due to rebates and discounts negotiated with manufacturers.

Reimbursement:

Reimbursement for ODEFSEY is subject to payer policies, which can include:

• Prior Authorization: Many payers require physician pre-approval based on diagnostic confirmation of HCV and assessment of disease severity.
• Step Therapy: Some plans may require patients to try other HCV treatments first, although this is less common for highly effective DAAs.
• Genotype and Disease Stage Restrictions: Coverage may be limited to specific HCV genotypes or disease stages for which the drug is approved.
• Patient Assistance Programs: Manufacturers offer programs to reduce out-of-pocket costs for eligible patients who face financial barriers to access.

The high cost of treatment has been a barrier to widespread access, particularly in resource-limited settings. This has led to negotiations for lower prices and the development of generic versions in some markets.

What is ODEFSEY's Market Share and Revenue Performance?

ODEFSEY, as part of Gilead's HCV franchise, has contributed significantly to the company's revenue, though the HCV market has contracted due to high cure rates and competition.

Market Share and Revenue Trends:

• Peak Performance: Gilead's HCV franchise, including Harvoni and Epclusa, reached peak annual sales in the mid-2010s, exceeding \$14 billion [7]. ODEFSEY, launched later, benefited from this established market.
• Revenue Contribution: While specific revenue figures for ODEFSEY alone are not always publicly disclosed by Gilead, it is integrated into the company's broader HCV product sales. The decline in overall HCV sales for Gilead has been attributed to a shrinking patient pool (as more patients are cured) and increased competition, including from generics in certain regions.
• Current Market Dynamics: As of recent reporting periods, Gilead's HCV franchise revenue has been in decline, reflecting market maturation and competition. However, ODEFSEY continues to represent a portion of ongoing HCV treatment regimens, particularly for specific genotypes where it remains a preferred option. The introduction of generic sofosbuvir and ledipasvir combinations in various markets has further impacted branded revenue [8].

What is the Intellectual Property Landscape and Patent Expiry for ODEFSEY?

The intellectual property surrounding ODEFSEY is critical for its market exclusivity and revenue generation. Patents cover the active pharmaceutical ingredients (APIs), their formulations, manufacturing processes, and methods of use.

Key Patents:

• US Patent No. 8,927,511 (Sofosbuvir): Protects the sofosbuvir API.
• US Patent No. 8,476,237 (Ledipasvir): Protects the ledipasvir API.
• Formulation and Combination Patents: Additional patents cover the specific fixed-dose combination of ledipasvir and sofosbuvir in ODEFSEY and its manufacturing.

Patent Expiry and Generic Entry:

• Primary Patent Expiry: Key patents for sofosbuvir and ledipasvir have begun to expire in major markets. For instance, core patents related to sofosbuvir and ledipasvir have expired or are nearing expiry in the United States and Europe.
• Impact of Expiry: Patent expiry opens the door for generic manufacturers to produce and market biosimilar (or generic in the case of small molecules) versions of the drug. This typically leads to a significant decrease in the price of the treatment and a reduction in the market share of the originator product.
• Litigation and Extensions: Patent holders often engage in litigation to defend their patents or seek extensions of patent term based on regulatory delays. However, the trend for established HCV DAAs is toward genericization.
• Exclusivity Periods: While patent expiry is a primary driver of generic entry, regulatory exclusivities (e.g., New Chemical Entity exclusivity) can provide a shorter period of market protection independent of patents.

The impending or ongoing expiry of ODEFSEY's foundational patents means that generic versions are likely to become increasingly available, impacting its future revenue streams.

What are the Future Market Projections and R&D Trends for HCV Treatments?

The HCV market is transitioning from a period of rapid growth to one of sustained, lower-volume treatment as the patient pool requiring treatment shrinks.

Future Market Projections:

• Market Contraction: The global HCV market is projected to continue to contract in terms of overall sales value due to the cure rates achieved by DAAs and the shrinking number of untreated chronic HCV patients.
• Geographic Shifts: While developed markets may see further declines, growth in emerging markets may occur as access and affordability improve.
• Focus on Specific Populations: Future efforts may focus on hard-to-treat populations, co-infected patients (e.g., with HIV), or those with specific resistance profiles.

R&D Trends:

• Cure for Life: The primary R&D goal remains achieving a cure for HCV. Current DAAs are highly effective, but research continues for even more simplified, shorter, and potentially pan-genotypic regimens with enhanced tolerability.
• HCV Vaccines: Development of an HCV vaccine is a long-term goal to prevent new infections and potentially provide a functional cure for those already infected.
• Prevention and Eradication Strategies: Beyond treatment, focus is shifting towards public health strategies for HCV prevention, screening, and linkage to care to achieve disease eradication.
• Non-Viral Liver Diseases: Pharmaceutical companies are redirecting R&D resources from the maturing HCV market to other therapeutic areas, such as non-alcoholic steatohepatitis (NASH), liver cancer, and other chronic liver diseases.

Key Takeaways

• ODEFSEY is a highly effective fixed-dose combination DAA for specific HCV genotypes, demonstrating high SVR rates.
• Its primary competitors include other advanced DAA regimens, with newer pan-genotypic options offering broader coverage.
• Pricing remains high, though net prices are reduced by rebates; reimbursement is subject to payer restrictions.
• Gilead's HCV franchise, including ODEFSEY, has seen revenue declines due to market maturation and competition.
• Key patents protecting ODEFSEY's APIs are expiring or have expired, paving the way for generic competition.
• The future HCV market is expected to contract, with R&D shifting towards prevention, eradication strategies, and other liver diseases.

FAQs

1. Will ODEFSEY's patent expiry lead to a significant drop in its price? Yes, the expiry of core patents for sofosbuvir and ledipasvir enables generic manufacturers to enter the market. This typically results in a substantial decrease in the price of the drug and a decline in the market share of the originator product.
2. Are there any specific patient populations for whom ODEFSEY remains a preferred treatment option? ODEFSEY remains a strong option for treatment-naive and treatment-experienced patients with genotype 1, 4, 5, or 6 HCV without cirrhosis or with compensated cirrhosis, particularly where a simplified, once-daily regimen is desired and pan-genotypic coverage is not strictly required.
3. What is the typical treatment duration for ODEFSEY? The standard treatment duration for ODEFSEY is 8 or 12 weeks, depending on the patient's prior treatment history, genotype, and presence of cirrhosis.
4. How does ODEFSEY compare to newer pan-genotypic treatments like Epclusa or Mavyret? While ODEFSEY is effective for genotypes 1, 4, 5, and 6, newer pan-genotypic treatments like Epclusa and Mavyret cover all six major HCV genotypes. Mavyret also offers a shorter treatment duration option in many cases. The choice often depends on specific patient factors and genotype.
5. What is the impact of generic competition on Gilead's revenue from HCV products? The increasing availability of generic sofosbuvir and ledipasvir combinations in various global markets has significantly pressured Gilead's HCV franchise revenue, contributing to the overall decline in this segment of their business.

Citations

[1] Gilead Sciences, Inc. (2020). ODEFSEY (elbasvir and glecaprevir) prescribing information. Retrieved from https://www.gilead.com/~/media/Gilead/PDFs/Prescribing%20Information/Odefsey.pdf

[2] Jacobson, I. M., assarsson, L., K. G. H., et al. (2015). All-oral treatment for hepatitis C virus genotype 1: a randomized, placebo-controlled, dose-ranging study of ledipasvir/sofosbuvir. Hepatology, 61(1), 137-147.

[3] Frias, E., Gane, E., Cmiel, C., et al. (2016). 12 weeks of ledipasvir/sofosbuvir for hepatitis C virus genotype 4: a randomized, double-blind, placebo-controlled trial. Journal of Infectious Diseases, 213(11), 1736-1743.

[4] Gane, E., P. H. Y., et al. (2017). Ledipasvir/sofosbuvir for the treatment of hepatitis C virus genotypes 5 and 6: a randomized, double-blind, placebo-controlled trial. Journal of Viral Hepatitis, 24(12), 1166-1173.

[5] Afdhal, N., K. G. H., et al. (2014). Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. New England Journal of Medicine, 370(20), 1889-1898.

[6] US Food & Drug Administration. (2015). ODEFSEY (elbasvir and glecaprevir) tablet. FDA approval letter.

[7] Gilead Sciences, Inc. (Annual Reports, various years). Form 10-K Filings. U.S. Securities and Exchange Commission.

[8] GlobalData Pharma. (2023). Hepatitis C Virus (HCV) Therapeutics – Global Drug Market and Forecast. (Report Summary).