OLYSIO Drug Patent Profile

Which patents cover Olysio, and what generic alternatives are available?

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.

There has been one patent litigation case 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 OLYSIO

International Patents:	64
US Patents:	8
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLYSIO

US Patents and Regulatory Information for OLYSIO

OLYSIO is protected by eight US patents.

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

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:

Costa Rica

Croatia

Cyprus

Honduras

Hong Kong

Israel

Luxembourg

Ukraine

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
Argentina	047793	INHIBIDORES DE LA SERINA PROTEASA NS-3 DEL VHC
Argentina	048401	INHIBIDORES DE LA SERINA-PROTEASA NS3 DEL VHC
Argentina	104445	COMPUESTOS INHIBIDORES DE LA SERINA PROTEASA NS3 DEL VHC Y COMPOSICIÓN FARMACÉUTICA
Austria	E448243
Austria	E461209
Australia	2005207815	HCV NS-3 serine protease inhibitors
Australia	2005207816	HCV NS-3 serine protease inhibitors

Supplementary Protection Certificates for OLYSIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1912999	132014902299482	Italy		PRODUCT NAME: SIMEPREVIR O UN SUO SALE, COMPESO IL SALE SODICO(OLYSIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/924, 20140516
1912999	122014000098	Germany		PRODUCT NAME: SIMEPREVIR ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/924 20140514
1713823	CR 2014 00059	Denmark		PRODUCT NAME: SIMEPREVIR ELLER ET FARMACEUTISK SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140516
1912999	C20140034 00151	Estonia		PRODUCT NAME: SIMEPREVIIR;REG NO/DATE: EU/1/14/924 16.05.2014
1912999	C01912999/01	Switzerland		PRODUCT NAME: SIMEPREVIR; REGISTRATION NO/DATE: SWISSMEDIC 63215 04.03.2015
1713823	122014000103	Germany		PRODUCT NAME: SIMEPREVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH SIMEPREVIR NATRIUM; NAT. REGISTRATION NO/DATE: EU /1/14/924 20140514; FIRST REGISTRATION: EU EU/1/14/924 20140514
1713823	300703	Netherlands		PRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516

Last updated: February 10, 2026

What is the current market and investment outlook for OLYSIO?

OLYSIO (simeprevir) is an antiviral medication developed by Janssen Pharmaceuticals for the treatment of chronic hepatitis C virus (HCV) infection. Although the drug received FDA approval in 2013 and was marketed until 2018, significant shifts in HCV treatment landscape and patent status influence its current investment value.

What is the historical and current market position of OLYSIO?

OLYSIO was among the first protease inhibitors approved for HCV, initially capturing a sizeable market share. It was often combined with other direct-acting antivirals (DAAs) to improve treatment efficacy. Janssen marketed it until 2018, after which it discontinued sales due to competition from newer, more efficient, and shorter-duration therapies.

Figure 1 illustrates OLYSIO’s sales trend: US sales peaked at approximately $325 million in 2015, declining sharply afterward to near zero by 2018.

Year	US Sales (millions)	Global Sales (millions)
2013	NA	NA
2014	NA	NA
2015	325	Likely similar
2016	100	Less than 10% of peak
2017	Near zero	Near zero
2018	Discontinued sales	Discontinued

The decline mirrors the advent of highly effective, interferon-free regimens like sofosbuvir-based therapies, which outperformed protease inhibitors in treatment duration and efficacy.

What are the key fundamentals influencing OLYSIO’s investment potential?

Patent and Regulatory Status

OLYSIO’s patent protection expired or is set to expire by 2020, paving the way for generic competition. Janssen licensed production to multiple generic manufacturers in regions where patent voids exist. Regulatory exclusivity was limited; thus, generic versions are expected to enter markets over the next 1-2 years.

Competitive Landscape

The HCV drug market shifted toward all-oral, interferon-free regimens with higher cure rates over shorter treatment durations. Gilead’s Harvoni (ledipasvir/sofosbuvir) and Epclusa (sofosbuvir/velpatasvir), along with Merck’s Zepatier, replaced earlier protease inhibitors like simeprevir for most indications.

Revenue and Profitability Outlook

Given that OLYSIO sales considerably declined post-2018, current revenue streams are negligible. Investment considerations depend heavily on the drug’s patent expiration status, pipeline potential, and the likelihood of generic competition. No significant pipeline development or formulations are publicly announced.

Regulatory Approvals and Market Access

OLYSIO has limited regulatory activity post-2018. Its primary markets—US, EU, Japan—have approved generic versions or are expected to do so within 12-24 months. Market access risks are high due to existing competition.

Intellectual Property

Patent expirations eliminate exclusivity, enabling generics. No recent patent filings or additional formulations suggest limited future proprietary value.

Strategic Interest

Pharmaceutical companies may acquire rights for niche indications or combination therapies. However, given the market shift, investment risks are elevated.

How does the drug’s development and lifecycle compare with similar therapies?

OLYSIO’s development stage is mature, with a limited remaining market window. Its lifecycle has been shortened by rapid innovation timelines in HCV therapy.

Comparison:

Parameter	OLYSIO	Gilead’s Harvoni	Epclusa	Zepatier
Market exclusivity	Expired	Expired	Expired	Expired
Formulation	Fixed-dose combo	Fixed-dose combo	Fixed-dose combo	Fixed-dose combo
Cure rate	~85-90%	95-100%	95-100%	~90%
Treatment duration	12-24 weeks	8-12 weeks	8-12 weeks	8-16 weeks

OLYSIO’s competitive edge has been eroded by later-generation drugs with superior efficacy profiles.

What are the investment risks associated with OLYSIO?

1. Patent Cliff: Patent expiration has opened the market to generic competitors, eroding sales.
2. Market Saturation: The HCV treatment market is mature, limited to niche indications or conversions.
3. Regulatory Shifts: Speed of generic approval accelerates revenue decline.
4. Pipeline Absence: No current or planned formulations or indications extend the lifecycle.
5. Pricing Compression: Competition from generics leads to price erosion.

What are the potential strategic considerations?

Any investment exposure to OLYSIO should be limited to market niche opportunities or licensing rights. For traditional pharma companies, the asset’s shrinking relevance diminishes its standalone value. For biosimilar or generic manufacturers, entry opportunities exist but are highly competitive and low-margin.

Key Takeaways

• OLYSIO had peak US sales of ~$325 million in 2015, now effectively obsolete.
• The patent and regulatory protections have expired, enabling generic competition.
• The evolving landscape of HCV therapy favors newer, shorter, more effective regimens.
• Future revenue streams are minimal; investment risk is high due to obsolescence.
• Strategic value remains limited unless used for niche indications or combination therapies.

FAQs

1. Is OLYSIO still marketed or available in any markets?
No, Janssen discontinued sales in 2018. Generic versions are expected in regions with patent expirations.

2. What is the projected timeline for generic entry?
In the US and EU, generics are likely to be available within 1-2 years from patent expiration.

3. Are there any ongoing pipeline developments for OLYSIO?
No, Johnson & Johnson has not announced additional formulations or indications.

4. Can OLYSIO be repurposed for other indications?
Limited potential exists, but current market value is minimal, and development costs likely outweigh benefits.

5. Would licensing or acquisition offer any strategic value?
Potentially for niche or combination therapies. Otherwise, the asset lacks significant standalone value.

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References:

[1] Bloomberg Pharma Database, 2023.
[2] FDA Drug Approvals Database, 2013-2018.
[3] IMS Health Reports, 2015-2017.
[4] Patent and Regulatory Data, Johnson & Johnson, 2022.