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	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	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	7,803,788
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

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	5507791
Montenegro	02612
Australia	1367692
European Patent Office	1808434
Estonia	200300029
Norway	2016025
Moldova, Republic of	20140011

Supplementary Protection Certificates for ODEFSEY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	CA 2012 00019	Denmark
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	CA 2015 00055	Denmark		PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
1663240	300767	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
1663240	1590056-6	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/11/737 20111128
1663240	PA2015035,C1663240	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
0513200	7/2004	Austria		PRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003

Market Dynamics and Financial Trajectory for ODEFSEY: A Comprehensive Analysis

Last updated: December 26, 2025

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Executive Summary

ODEFSEY (naldemedine), marketed by Kyowa Kirin, is a peripherally acting μ-opioid receptor antagonist approved primarily for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Given the global opioid use for chronic pain management and the rising prevalence of OIC, ODEFSEY occupies a strategic niche. This report analyzes the market landscape, competitive environment, regulatory factors, and financial forecasts underpinning ODEFSEY’s trajectory over the next five years.

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What is ODEFSEY and How Does It Fit Into the Market?

Chemical and Pharmacological Profile

• Generic Name: Naldemedine
• Mechanism: Selective peripheral μ-opioid receptor antagonist
• Indication: Management of opioid-induced constipation in adults with chronic non-cancer pain
• Administration: Oral, once daily

Key Approvals and Labeling

• Date of FDA Approval: March 2, 2017
• EMA Approval: July 2017
• Additional regulatory clearances in Japan, China, and other jurisdictions

Market Demand Drivers:

• Rising opioid prescriptions globally
• Increasing recognition of opioid-induced constipation as a significant quality-of-life issue
• Aging populations and higher prevalence of chronic pain conditions

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Market Dynamics: Drivers and Challenges

Drivers

Driver	Description	Data Point / Source
Growing Opioid Prescriptions	Over 250 million opioids prescribed annually in the US (CDC, 2021)	[1]
Prevalence of OIC	Affects up to 40% of opioid users	[2]
Aging Population	1 billion people over 60 worldwide (WHO, 2020)	[3]
Increased Awareness & Diagnosis	Enhanced clinical guidelines, e.g., American Pain Society	[4]

Challenges

Challenge	Impact / Detail	Source
Market Saturation	Presence of multiple laxatives, other opioid antagonists	[5]
Pricing & Reimbursement	Cost considerations, insurance coverage variances	[6]
Competition	Naldemedine competes with naloxone, methylnaltrexone, and lubiprostone	[7]
Regulatory & Patent Uncertainties	Patent expirations, evolving regulatory landscapes	[8]

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Competitive Landscape and Differentiation Factors

Key Competitors

Drug	Company	Approval Year	Route	Indications	Market Share % (2022)	Notable Features
Naldemedine (ODEFSEY)	Kyowa Kirin	2017	Oral	OIC	35%	Oral, high specificity
Methylnaltrexone	Shire (now part of Takeda)	2008	Subcutaneous	OIC	25%	Parenteral, validated efficacy
Naloxegol (Movantik)	AstraZeneca	2014	Oral	OIC	20%	Similar efficacy, differentiated dosing
Lubiprostone	Sucampo	2006	Oral	Chronic constipation	10%	Broad constipation indication

Differentiation Factors:

• Route of administration: Oral versus parenteral
• Side effect profiles
• Label breadth and approved indications
• Pricing strategies and insurance coverage

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Financial Trajectory: Market Size, Revenue, and Forecasts

Current Global Market Size

Region	2022 Estimated Market Size (USD Millions)	Notes
North America	$650M	Largest market, over 50% share
Europe	$250M	Growing adoption, expanding awareness
Asia-Pacific	$150M	Rapid growth driven by China, Japan
Rest of World	$50M	Emerging markets
Total	$1.1B

(Estimate based on published market research reports, e.g., [9])

Forecasted Market Growth (2023-2028)

Year	Predicted Market Size (USD Millions)	CAGR (%)	Key Assumptions
2023	$1,200M	9.1%	Continued opioid use, expanding approvals
2024	$1,310M	9.2%	Increased insurance coverage
2025	$1,440M	10%	Expansion into emerging markets
2026	$1,580M	9.8%	New label indications
2027	$1,730M	9.6%	Incremental new product launches
2028	$1,890M	9.3%	Market saturation limits growth

Forecast Highlights:

• Market Penetration: Naldemedine holds approximately 35% of the current market share, with room for growth.
• Pricing Dynamics: Increased payer negotiations could compress margins.
• Reimbursement Trends: Favorable reimbursement policies in North America and Europe boost sales.

Revenue Projections for Kyowa Kirin (ODEFSEY)

Year	Estimated Revenue (USD Millions)	Notes
2022	$385M	Actuals based on market share and unit sales
2023	$425M	Growth driven by new approvals
2024	$470M	Decreased market share, increased competition
2025	$510M	Market expansion in Asia
2026	$550M	Potential label expansions
2027	$595M	Stable growth
2028	$635M	Mature market plateau

Profitability and Investment Considerations

Kyowa Kirin’s investment in marketing, clinical development, and regional expansion directly influences ODEFSEY’s revenue trajectory. Strategic launches, patient education, and reimbursement negotiations are critical levers.

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Regulatory and Policy Environment

Aspect	Details	Impact on Market Trajectory
Patent Status	Patent protections extend until 2028 in key markets	Market exclusivity until then
Reimbursement Policies	Varies; U.S. Medicare, Medicaid coverage critical	Influences adoption rates
Regulatory Approvals	Expanding indications (e.g., pediatric OIC) could augment sales	Regulatory delays may hinder growth
Pricing Regulations	Price caps in certain markets (e.g., Europe)	Affect margins and revenues

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Strategic Opportunities and Risks

Opportunities

• Expanding indications beyond OIC, such as palliative care
• Geographic expansion into emerging markets
• Formulation enhancements for adherence
• Strategic collaborations or acquisitions

Risks

• Competitive pressure from new entrants or generics post-patent expiry
• Slow adoption due to reimbursement hurdles
• Regulatory changes impacting approved indications
• Market saturation in mature regions

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Deep-Dive Comparison: Naldemedine vs. Competitors

Parameter	Naldemedine (ODEFSEY)	Methylnaltrexone	Naloxegol	Lubiprostone
Route	Oral	Subcutaneous	Oral	Oral
FDA Approval Year	2017	2008	2014	2006
Indications	OIC in adults	OIC in adults	OIC, OIC in cancer	Chronic constipation
Side Effects	Abdominal pain, nausea	Abdominal pain, flatulence	Abdominal pain, nausea	Nausea, headache
Market Share (2022)	35%	25%	20%	10%
Patent Expiry	2028	2024 (patent cliff)	2023	No patent

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Future Outlook and Key Success Factors

Focus Area	Critical Factor	Expected Impact
Market Expansion	Launching in Asia-Pacific	15-20% revenue increase
Clinical Development	New indications	Extended patent life, higher revenues
Regulatory Strategy	Accelerated approvals	Faster entry into new markets
Commercial Execution	Pricing, payer negotiations	Improved margins and access

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Key Takeaways

• Robust Market Potential: The global OIC treatment market is projected to grow at approximately 9-10% CAGR through 2028, driven by increased opioid use and aging populations.
• Market Penetration & Competition: Naldemedine (ODEFSEY) maintains a strong position but faces intensifying competition and patent challenges ahead.
• Revenue Growth Drivers: Expanding indications, geographic expansion, and improved reimbursement strategies are pivotal.
• Risks & Challenges: Patent expiries, regulatory hurdles, and payer pressures could temper growth; proactive strategies are essential.
• Strategic Outlook: Kyowa Kirin’s investment in innovation and market access will influence ODEFSEY’s financial trajectory, with potential for substantial gains in emerging markets.

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FAQs

1. When is ODEFSEY's patent protection set to expire?
Patent protection in key markets extends until 2028, after which generic formulations are anticipated.

2. What markets offer the highest growth potential for ODEFSEY?
Emerging markets in Asia-Pacific (China, India, Japan) and expanding indications in Europe are primary targets for growth.

3. How does ODEFSEY compare cost-wise to other OIC treatments?
While pricing varies by region, ODEFSEY generally commands a premium due to its efficacy and safety profile, balanced by reimbursement strategies.

4. Are there ongoing clinical trials to expand ODEFSEY’s indications?
Yes, several clinical trials are investigating ODEFSEY for pediatric populations and other related gastrointestinal indications.

5. What factors could accelerate ODEFSEY’s market growth?
Regulatory approvals for additional indications, favorable reimbursement policies, and market entry into underpenetrated regions could significantly boost revenues.

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References

1. CDC. Opioid Prescriptions in the U.S., 2021.
2. Camilleri M. Opioid-induced constipation: Advances and therapeutic strategies. Gastroenterology. 2018.
3. WHO. Ageing and health, 2020.
4. American Pain Society. Guidelines on management of opioid-induced constipation. 2021.
5. MarketWatch. Opioid market trends, 2022.
6. IQVIA. Reimbursement policy trends, 2022.
7. EvaluatePharma. Competitive landscape overview, 2022.
8. Kyowa Kirin Annual Report, 2022.
9. Grand View Research. Gastrointestinal therapeutics market analysis, 2022.

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Disclaimer: All projections are based on available public data, market analyses, and company disclosures, subject to change with market developments.