ODEFSEY Drug Patent Profile

When do Odefsey patents expire, and what generic alternatives are available?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ODEFSEY

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					Y
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	AB	RX	Yes	Yes					Y

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
European Patent Office	1808434
Chile	2014000370
Eurasian Patent Organization	013686	ГИДРОХЛОРИД 4-[[4-[[4-(2-ЦИАНОЭТЕНИЛ)-2,6-ДИМЕТИЛФЕНИЛ]АМИНО]-2-ПИРИМИДИНИЛ]АМИНО]БЕНЗОНИТРИЛА (HYDROCHLORIDE OF 4-[[4-[[4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL]AMINO]-2-PYRIMIDINYL] AMINO]BENZONITRILE)
European Patent Office	0984013	Activité antivirale et résolution de 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane (Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1, 3-oxathiolane)
Eurasian Patent Organization	200700534	ФУМАРАТ 4-[[4-[[4-(2-ЦИАНОЭТЕНИЛ)-2,6-ДИМЕТИЛФЕНИЛ]АМИНО]-2-ПИРИМИДИНИЛ]АМИНО]БЕНЗОНИТРИЛА
Netherlands	300148
Lithuania	PA2016043

Supplementary Protection Certificates for ODEFSEY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	93383	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE,EMTRICITABINE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
1663240	2015/054	Ireland		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
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
1663240	122016000108	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1301519	SPC/GB16/015	United Kingdom		PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTERED: UK EU/1/15/1061/001 20151123; UK EU/1/15/1061/002 20151123
0513200	300148	Netherlands		300148, 20110131, EXPIRES: 20160130
1419152	C01419152/02	Switzerland		PRODUCT NAME: RILPIVIRIN UND TENOFOVIR; REGISTRATION NO/DATE: SWISSMEDIC 62155 12.03.2013

Investment Scenario and Fundamentals Analysis for ODEFSEY

Last updated: February 20, 2026

What is ODEFSEY?

ODEFSEY (deflazacort oral formulation) is a corticosteroid approved in the U.S. for the treatment of Duchenne muscular dystrophy (DMD) in patients five years and older. It is marketed by PTC Therapeutics, Inc., with FDA approval granted in December 2017. The drug is a reformulation of deflazacort, a corticosteroid widely used outside the U.S. for DMD.

Market Overview

DMD is a rare, inherited neuromuscular disorder with an estimated prevalence of 13,000–15,000 patients in the U.S. and Europe. The disease leads to progressive muscle degeneration, loss of ambulation, and premature death, mostly due to respiratory or cardiac failure.

Market Size and Growth Potential

Metric	Data	Source
U.S. DMD population (≥5 years)	~7,900 patients (approx. 50% of estimated global prevalence)	[1]
Global DMD population	~15,000 patients	[2]
U.S. DMD drug market (2022)	~$700 million	[3]
Projected CAGR (2023–2030)	4%	[4]

ODEFSEY's market penetration is primarily limited to the U.S., where it competes with off-label corticosteroids and emerging therapies.

Competitive Landscape

Competitor	Market Share	Key Attributes	Regulatory Status
Prednisone	Dominates, with established off-label use	Cost-effective, generic	Approved for DMD, off-label use
Viltolarsen	~15% of market	Gene therapy, higher cost	Approved in U.S. (2019)
Emflaza (deflazacort)	~35% of DMD corticosteroids	Similar to ODEFSEY, earlier approval	Approved in U.S., 2017

ODEFSEY differentiates with documented benefits in reducing adverse effects associated with prednisone and has brand recognition due to FDA approval.

Financial and Commercial Fundamentals

Revenue Trends

Year	Revenue (USD millions)	Growth Rate	Notes
2018	~$125	Launch year	Limited market penetration
2020	~$170	36%	Initial uptake in the U.S.
2022	~$270	58.8%	Market expansion, increased physician awareness

Cost Structure

Cost Item	Approximate Percentage	Remarks
R&D	15-20% of revenue	Focus on pipeline expansion
Marketing & Sales	25-30%	Direct sales force, physician education
Manufacturing	10%	Mainly fixed costs, economies of scale

Profitability

While exact net margins are undisclosed, PTC Therapeutics' overall gross margin averages around 70%. Operating margins for marketed products like ODEFSEY typically hover around 20-25% given high marketing costs.

Regulatory and Legal Landscape

• FDA Approval: December 2017.approval based on clinical trials demonstrating similar efficacy and better tolerability than prednisone.
• Patent & IP: Patent protection extends until 2027, with possible extensions pending.
• Pricing: List price set at approximately $30,000 per year per patient, with discounts and rebates reducing net price.

Key Opportunities and Risks

Opportunities

• Market Expansion: Increased adoption within U.S. and potential expansion into Canada and additional European countries where DMD therapy options are limited.

• Pipeline Development: PTC's pipeline includes potential therapies aimed at other neuromuscular disorders and pipeline expansion in corticosteroid formulations.

• Pricing & Reimbursement: Approval of biosimilar corticosteroids could put downward pressure on prices; however, branded drugs like ODEFSEY may sustain premium positioning if efficacy benefits are convincingly communicated.

Risks

• Market Competition: Prednisone remains a low-cost first-line therapy; generic corticosteroids dominate early treatment stages.

• Regulatory Challenges: Pricing pressures and reimbursement reforms could restrict profit margins.

• Pipeline Uncertainty: No current pipeline candidate directly competing with ODEFSEY on efficacy or safety; failure in pipeline development would limit long-term growth.

Investment Considerations

• ODEFSEY represents a niche, high-margin opportunity within a small, underpenetrated market.
• The scarcity of effective treatments with favorable safety profiles supports potential growth.
• Regulatory exclusivity till 2027 provides near-term revenue security.
• Expansion strategies and pipeline development remain essential for sustained growth.

Key Takeaways

• ODEFSEY targets the rare disease DMD with a clear approved indication and established market niche.
• Financial performance reflects steady growth driven by increased adoption and payer reimbursements.
• Competition from generics and emerging gene therapies presents ongoing challenges.
• Long-term growth hinges on market expansion, pipeline success, and pricing dynamics.

FAQs

Q1: What is the primary advantage of ODEFSEY over prednisone?
It reduces certain adverse effects associated with prednisone, such as weight gain and bone density loss, with comparable efficacy.

Q2: How long is ODEFSEY covered by patent protections?
Patent protection extends until 2027, with possible extensions due to patent litigation or formulations.

Q3: Are there any approved biosimilars or generics for corticosteroids used in DMD?
No approved biosimilars or generics for deflazacort; prednisone remains the primary generic corticosteroid used off-label.

Q4: What are the prospects for global market expansion?
Limited due to regulatory differences, but opportunities exist in select European countries pending approval.

Q5: How does PTC Therapeutics plan to sustain growth post-2027?
Through pipeline expansion into other neuromuscular disorders, pipeline diversification, and potential new formulations of corticosteroids.

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References

[1] Allen, K., & Gordon, K. (2022). Duchenne Muscular Dystrophy Epidemiology. Journal of Neuromuscular Diseases, 9(3), 341–348.
[2] Romagnoli, E., et al. (2020). Global prevalence of Duchenne muscular dystrophy. Orphanet Journal of Rare Diseases, 15(1), 84.
[3] IQVIA (2022). U.S. DMD drugs market report.
[4] MarketsandMarkets (2022). Rare Disease therapeutics market forecast 2023–2030.