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 eight patents protecting this drug.

This drug has sixty-four patent family members in forty-one 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:	64
US Patents:	8
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
Yale University	Phase 4
Stanford University	Phase 4
Alexion Pharmaceuticals	Phase 1

See all OLYSIO clinical trials

US Patents and Regulatory Information for OLYSIO

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

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
Israel	176848	תרכובות מעכבות 3- hcv ns סרין פרוטאז, תכשירים רוקחיים המכילים אותן ושימושים בהן (Hcv ns-3 serine protease inhibiting compounds, pharmaceutical compositions comprising them and uses thereof)
Portugal	2322516
South Korea	20120090077	HCV NS-3 SERINE PROTEASE INHIBITORS
China	103030636	Macrocyclic inhibitors of hepatitis c virus
Japan	2007524670

Supplementary Protection Certificates for OLYSIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713823	132014902308868	Italy		PRODUCT NAME: SIMEPREVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, COMPRESO IL SALE SODICO(OLYSIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/924, 20140516
1713823	CR 2014 00059	Denmark		PRODUCT NAME: SIMEPREVIR ELLER ET FARMACEUTISK SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140516
1912999	14C0076	France		PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516
1713823	C300703	Netherlands		PRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140514
1912999	2014/058	Ireland		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516

Market Dynamics and Financial Trajectory for OLYSIO (Simeprevir)

Last updated: January 9, 2026

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Summary

OLYSIO (simeprevir) is an oral NS3/4A protease inhibitor developed by Janssen Pharmaceuticals, primarily indicated for chronic hepatitis C virus (HCV) infections. Approved in 2013, OLYSIO contributed to the shift towards direct-acting antivirals (DAAs), which significantly enhanced cure rates and reduced treatment durations. This analysis examines the evolving market landscape, sales performance, competitive positioning, and future prospects for OLYSIO, considering recent trends in hepatitis C therapies and patent considerations.

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Introduction to OLYSIO (Simeprevir): Clinical and Regulatory Background

Mechanism of Action & Indication

Attribute	Details
Pharmacology	NS3/4A protease inhibitor
Indication	Chronic HCV genotype 1 and 4 infections (approved in several countries)
Approval Date	Japan (Jan 2013), US (Nov 2013), EU (Dec 2013)
Dosing	150 mg once daily, with peginterferon and ribavirin (prior to interferon-free regimens)

Regulatory Status

Region	Status	Notes
United States (FDA)	Approved	Marked as one component of HCV combination therapies, later phased out due to newer direct-acting antivirals
European Union	Approved	Similar to US, primarily used until newer regimens emerged
Japan	Approved	Widely prescribed before patent expiry

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Market Dynamics

Historical Sales Performance and Decline

Following its initial success, OLYSIO's market share was notably strong between 2013-2017, driven by the demand for effective HCV treatments. However, the rapid advent of newer DAAs has profoundly affected its trajectory.

Year	Global Sales (USD million)	Key Trends & Events
2013	~$325	Launch year, high uptake using traditional combination therapies
2014	~$460	Peak sales; integration into various regimens
2015	~$370	Early signs of decline as newer agents emerge
2016	~$200	Clearance accelerated due to competition
2017	~$120	Significantly reduced, nearly phased out in key markets

Source: EvaluatePharma, Nov 2022

Influence of Competitive Landscape

OLYSIO faced stiff competition from prominent DAAs such as:

• Sofosbuvir (Harvoni, Sovaldi) by Gilead Sciences
• Viekira Pak (AbbVie)
• Mavyret (Glecaprevir/Pibrentasvir, AbbVie)
• Epclusa (Sofosbuvir/Velpatasvir, Gilead)

The superior efficacy, shorter treatment durations, and better side effect profiles of these agents led to OLYSIO's decline.

Competition Factor	OLYSIO	Major Competitors	Advantages
Efficacy	Moderate (~90-95% SVR in combination regimens)	Higher (often >95%)	Newer agents demonstrate broader genotypic coverage and better SVR rates
Duration	Up to 24 weeks	8-12 weeks	Shorter therapies with higher convenience
Side Effects	Photosensitivity, rash	Less severe	Improved tolerability of competitors

Patent and Patent Expiry Impact

• Patent expiry in key markets: 2019-2020
• Generic Availability: Increased pressure on prices and margins
• Impact: Accelerated sales decline post-patent expiration

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Financial Trajectory Analysis

Revenue Decline and Profitability Trends

Year	Approximate Revenue (USD million)	Cumulative Impact	Implication
2013	$325	Launch year	High initial revenues, foundation for growth
2014	$460	Peak sales	Market expansion and adoption
2015	$370	Growth plateau	Beginning of competitive pressure
2016	$200	Rapid decline	Patent expiry pressures materialize
2017	$120	Declining	Market exit expected

Profit Margins and R&D Investment

OLYSIO's profit margins shrank concomitantly with sales decline:

• Gross Margins: ~85% initially, fell to ~50% by 2017 due to generic competition
• R&D Allocation: Focus shifted to pipeline development, notably NS5A and NS5B inhibitors for HCV and other antiviral agents
• Cost of Goods Sold (COGS): Reduced as manufacturing scaled down

Forecasting Future Revenue

Given patent expiration and market saturation:

Scenario	Market Penetration	Estimated Residual Revenue (2023-2025)	Notes
Conservative	5-10% of initial peak	<$20 million annually	In markets with limited generics or specific niche use
Optimistic	None	Approaching zero	Unless repositioned for new indications

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Current Market Position and Future Outlook

Status as of 2023

• Limited off-label usage in certain regions
• Generic availability in many markets
• Commercial discontinuation declared by Janssen in some geographies

Potential for Repositioning or Pediatric Use

While the primary HCV indication is being phased out rapidly, opportunities exist in:

• Drug combination testing
• Research for resistant HCV strains

However, no significant new indications have been approved or are in late-stage development.

Strategic Considerations

Factor	Implication	Strategy
Patent expiry	Revenue erosion	Focus on pipeline diversification
Competition	Market share loss	Improve formulations, explore new indications
Therapy landscape	Favorable shift	Emphasize newer, pan-genotypic DAAs

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Comparative Analysis: OLYSIO vs. Core Competitors

Criteria	OLYSIO (Simeprevir)	Gilead’s Harvoni	Viekira Pak	Mavyret
Approval Year	2013	2014	2014	2017
Efficacy (SVR12)	~90-95%	~95-99%	~90-95%	~98%
Treatment Duration	Up to 24 weeks	8-12 weeks	12-24 weeks	8 weeks
Genotype Coverage	1 & 4	1, 4, 2, 3	1, 4	1-6
Side Effects	Rash, photosensitivity	Fatigue, headache	Fatigue, nausea	Well tolerated
Market Peak Revenue	~$460 million	Over $10 billion (initial)	Several hundred million	Several hundred million

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FDA and Global Regulatory Policies Impacting Market Trajectory

• FDA’s shift towards pan-genotypic regimens led to deprioritization of drugs like simeprevir.
• Market Entry Barriers: Strict approval processes and evolving treatment guidelines emphasizing newer agents.
• Pricing and Reimbursement: Cost-containment measures favor newer, more effective drugs with broader coverage.

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Key Drivers and Challenges

Drivers	Challenges
Rapid development of highly efficacious DAAs	Patent expiration reducing exclusivity
Favorable treatment outcomes	Competition from generics
Shifts towards interferon-free, shorter regimens	Limited future indication pipeline

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Key Takeaways

• Market Entry & Success: OLYSIO initially gained substantial market share due to its efficacy in HCV genotype 1, but was quickly overshadowed by more effective, shorter, and better-tolerated therapies.
• Sales Decline: From a peak of approximately $460 million in 2014 to near obsolescence post-2019, with residual revenues primarily from legacy or niche uses.
• Competitive Landscape: Dominated by pan-genotypic DAAs that offer streamlined treatment, eroding OLYSIO’s relevance.
• Patent & Market Exit: Patent expiry facilitated generic entry, eroding pricing power and profitability.
• Future Outlook: Minimal revenue prospects barring new indications; strategic focus has shifted to R&D pipelines.
• Lessons for Stakeholders: Emphasize innovation and diversification to sustain long-term value amid rapid therapeutic advancements.

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FAQs

1. Why did OLYSIO (simeprevir) fail to sustain long-term market leadership?
The advent of pan-genotypic, interferon-free DAAs offering higher SVR rates, shorter treatment durations, and better tolerability rendered simeprevir obsolete, leading to rapid sales decline and market exit post-patent expiry.

2. What are the main competitors that replaced OLYSIO in hepatitis C therapy?
Gilead’s Harvoni and Epclusa, AbbVie's Viekira Pak and Mavyret, and Sofosbuvir-based combinations dominate current markets due to superior efficacy and broader genotypic coverage.

3. Has OLYSIO been approved for any new indications?
As of 2023, no new indications have been approved. The primary focus remains on existing legacy uses, which are declining.

4. How does patent expiry affect the revenue trajectory of drugs like OLYSIO?
Patent expiry allows generic manufacturers to enter the market, drastically reducing prices and sales volumes, effectively ending the original patent holder’s revenue stream from the molecule.

5. Are there ongoing efforts to repurpose or reposition simeprevir?
Current efforts are limited; research into resistant HCV strains or combination therapies exists but has not resulted in new approved indications.

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References

1. EvaluatePharma, "World Preview 2022," 2022.
2. US FDA, "Approval Package for Simeprevir," 2013-2014.
3. European Medicines Agency, "Summary of Product Characteristics," 2013.
4. Gilead Sciences, "Sofosbuvir and Ledipasvir (Harvoni) Market Data," 2022.
5. Janssen Pharmaceuticals, "OLYSIO (Simeprevir) Label," 2013, 2018.