OLYSIO Drug Patent Profile

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

Olysio is a drug marketed by Janssen Prods and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and forty patent family members in forty-three countries.

The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this compound. Additional details are available on the simeprevir sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Olysio

Olysio was eligible for patent challenges on November 22, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 5, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OLYSIO

International Patents:	140
US Patents:	9
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	7
Patent Applications:	1,537
Drug Prices:	Drug price information for OLYSIO
DailyMed Link:	OLYSIO at DailyMed

See drug prices for OLYSIO

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

NDA:

205123

Dosage:

CAPSULE;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 OLYSIO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Stanford University	Phase 4
Yale University	Phase 4
Alios Biopharma Inc.	Phase 1

See all OLYSIO clinical trials

US Patents and Regulatory Information for OLYSIO

OLYSIO is protected by nine US patents.

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
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No			Y	Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No			Y	Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No

Expired US Patents for OLYSIO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013

International Patents for OLYSIO

When does loss-of-exclusivity occur for OLYSIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Brazil

Canada

China

Costa Rica

Croatia

Cyprus

Denmark

El Salvador

Eurasian Patent Organization

European Patent Office

Honduras

Hong Kong

Hungary

Israel

Luxembourg

Montenegro

Portugal

Serbia

Slovenia

South Korea

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 OLYSIO around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2342944
European Patent Office	2322516	Composés intermédiaires pour la préparation d'inhibiteurs macrocycliques du virus de l'hépatite C (Intermediates for the preparation of Macrocyclic inhibitors of hepatitis c virus)
Hong Kong	1116771	MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS
Ukraine	95245	МАКРОЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ВИРУСА ГЕПАТИТА С;МАКРОЦИКЛІЧНІ ІНГІБІТОРИ ВІРУСУ ГЕПАТИТУ С (MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS)

Supplementary Protection Certificates for OLYSIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1912999	122014000098	Germany		PRODUCT NAME: SIMEPREVIR ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/924 20140514
1912999	C 2014 040	Romania		PRODUCT NAME: SIMEPREVIR SAU O SARE A ACESTUIA, INCLUSIV SIMEPREVIRSODIU; NATIONAL AUTHORISATION NUMBER: EU/1/14/924; DATE OF NATIONAL AUTHORISATION: 20140514; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/924; DATE OF FIRST AUTHORISATION IN EEA: 20140514
1713823	92595	Luxembourg		PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516

Market Dynamics and Financial Trajectory for OLYSIO (Simeprevir)

Last updated: July 27, 2025

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Introduction

OLYSIO (simeprevir) is an antiviral medication developed by Johnson & Johnson’s Janssen Pharmaceuticals. Approved in 2013 for the treatment of chronic hepatitis C virus (HCV) infection, OLYSIO represents a significant advancement in direct-acting antiviral (DAA) therapies. As the landscape of hepatitis C treatment evolves rapidly, understanding the market dynamics and financial trajectory of OLYSIO is essential for stakeholders, including pharmaceutical companies, investors, healthcare providers, and policymakers.

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Market Overview

HCV Therapeutic Landscape

The global hepatitis C treatment market comprises various DAAs, with a focus on high efficacy, shorter treatment durations, and minimal side effects. Since the approval of OLYSIO, the market has been characterized by intense competition from other DAAs such as Harvoni (ledipasvir/sofosbuvir), Epclusa (sofosbuvir/velpatasvir), and Mavyret (glecaprevir/pibrentasvir). The evolution reflects a paradigm shift towards simplified, pan-genotypic, and highly effective treatment regimens.

OLYSIO’s Market Position

Initially, OLYSIO entered the market as a segment-specific HCV treatment, particularly targeting genotype 1, which is the most prevalent form globally. Its mechanism as a protease inhibitor positioned it as part of combination therapies rather than a standalone cure. However, with the advent of more potent, pan-genotypic regimens, OLYSIO’s market share experienced decline.

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Market Dynamics Influencing OLYSIO

1. Evolving Treatment Guidelines

Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) increasingly favor all-oral, pan-genotypic regimens with higher cure rates and fewer side effects. These developments diminish OLYSIO’s relative value, especially in markets where newer therapies are accessible and affordable.

2. Patent Status and Generic Competition

OLYSIO’s patent expired in many regions by 2018. This expiration enabled generic manufacturers to produce cost-effective versions, significantly impacting sales volume. The entry of generics has intensified price competition, especially in low- and middle-income countries, further eroding OLYSIO’s profitability.

3. Regulatory and Market Approvals

While initially approved in the U.S., Europe, and select markets, the subsequent regulatory landscape shifted favorably toward newer regimens. The reduced official indications for OLYSIO reflect its diminished role as a first-line therapy, influencing market access and reimbursement policies.

4. Pricing and Reimbursement Policies

Pricing strategies and reimbursement frameworks heavily influence sales trajectories. Governments and payers prioritize cost-effective therapy options, often favoring newer DAAs with broader indications. OLYSIO’s positioning as a legacy drug constrains its reimbursement prospects, though it remains affordable in generic form.

5. Clinical Efficacy and Side Effect Profile

While initially celebrated for its efficacy against genotype 1, the drug's safety and tolerability profile has been superseded by newer agents with fewer adverse events. Consequently, clinicians prefer newer therapies, limiting OLYSIO’s market penetration.

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Financial Trajectory Analysis

Historical Revenue Trends

• 2013-2015: Fast initial uptake and strong sales driven by the unmet need for effective HCV therapies.
• 2016-2017: Peak revenues, reaching hundreds of millions of dollars annually for Johnson & Johnson.
• Post-2018: Sharp decline as patent expirations and competition from next-generation DAAs gained prominence.

Current and Projected Revenue Outlook

Given the market’s shift, OLYSIO’s revenue stream has plateaued and declined significantly. In 2022, Johnson & Johnson’s contribution from OLYSIO likely dropped to low single-digit figures relative to earlier years. Future revenues for this drug are expected to be minimal, primarily derived from off-label uses, markets where generic penetration is limited, or as part of combination regimens in niche indications.

Profitability and Strategic Considerations

The declining market share challenges profitability. Johnson & Johnson has largely relegated OLYSIO to a legacy portfolio, reallocating resources toward innovative therapies and vaccines. This strategic pivot suppresses investments, further constraining the drug’s financial trajectory.

Investment and Acquisition Landscape

While direct investments in OLYSIO have waned, alternative opportunities lie in licensing and repurposing legacy antivirals within broader hepatitis C or other viral disease frameworks. Companies looking to enter emerging markets or utilize generic formulations might find niche value propositions.

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Market Opportunities and Challenges

Opportunities

• Generic Version Utilization: Cost-effective generics expand access in developing regions, potentially stabilizing sales in specific markets.
• Combination Therapy Components: Some markets may continue using OLYSIO as part of combination regimens for specific genotype cases.
• Legacy and Off-Label Uses: Targeted, off-label applications where newer therapies are unavailable or impractical could sustain limited revenue streams.

Challenges

• Market Obsolescence: Rapid move towards pan-genotypic, all-oral regimens limits the drug's relevance.
• Price Competition: Generic competition and pricing pressures make profitability challenging.
• Regulatory Barriers: Reduced official approvals restrict market access and reimbursement prospects.

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Conclusion: Strategic Outlook for OLYSIO

The pharmaceutical market landscape for OLYSIO is characterized by contraction rather than expansion. The drug’s initial success was driven by unmet medical needs and limited competitors; however, subsequent innovations have eclipsed its market position. With patent expirations, the influx of generics, and evolving treatment guidelines favoring newer modalities, OLYSIO’s financial trajectory is expected to remain in decline.

Stakeholders should consider leveraging its legacy position in specific markets or niche indications while investing in next-generation antivirals. For Johnson & Johnson, the strategic focus will likely shift toward novel therapeutics and combination regimens that offer better efficacy and safety profiles, leaving OLYSIO as a diminishing asset.

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Key Takeaways

• OLYSIO experienced peak sales shortly after approval in 2013 but faced rapid declines post-2018 due to patent expiry and competition.
• The global shift toward pan-genotypic, all-oral DAAs significantly reduced the drug’s market share.
• Generic entry has intensified price competition, especially in emerging markets, constraining profitability.
• The evolving hepatitis C treatment landscape favors newer therapies, relegating OLYSIO to a secondary or legacy status.
• Future prospects are limited, with the drug serving primarily in niche markets or as a component of combination therapies in resource-constrained settings.

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FAQs

1. Why did OLYSIO’s market share decline so rapidly after its initial success?
Its decline resulted from the advent of more effective, pan-genotypic DAAs with better safety profiles, shorter treatment durations, and broader indications. Additionally, patent expiration facilitated generic competition, further reducing market share.

2. Are there any ongoing clinical uses of OLYSIO?
Its primary clinical use has diminished significantly. While it may still be used in specific niche scenarios or off-label, such applications are limited and unlikely to sustain commercial viability.

3. How does patent expiration affect the financial trajectory of drugs like OLYSIO?
Patent expiration enables generic manufacturers to produce cost-effective versions, leading to substantial revenue declines for the originator drug and increasing market competition.

4. What are the main factors shaping the future of legacy antivirals like OLYSIO?
Market relevance depends on patent status, emerging treatment guidelines, availability of affordable generics, and ongoing demand in resource-limited settings.

5. Could OLYSIO regain market relevance through formulation or combination innovations?
Unlikely, given the dominance of newer therapies with superior efficacy and safety. Focus is more on developing next-generation antivirals than repositioning legacy drugs.

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Sources:
[1] PhRMA. “Hepatitis C: The Changing Landscape of Treatment.” 2022.
[2] FDA. “Olysio (Simeprevir) Approved in 2013.” 2013.
[3] IMS Health. “Global Hepatitis C Market Report.” 2021.
[4] Johnson & Johnson. “OLYSIO Product Information.” 2022.
[5] European Medicines Agency. “Simeprevir Marketing Authorisation Details.” 2013.