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 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:	49
Clinical Trials:	7
Patent Applications:	702
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

Constraining patent/regulatory exclusivity:

8,148,399

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
Alexion Pharmaceuticals	Phase 1

See all OLYSIO clinical trials

US Patents and Regulatory Information for OLYSIO

OLYSIO is protected by nine US patents.

This potential generic entry date is based on patent 8,148,399.

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	8,349,869		Y	Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	9,353,103
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	9,040,562		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:

African Regional IP Organization (ARIPO)

Argentina

Australia

Austria

Brazil

Canada

China

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Germany

Guatemala

Honduras

Hong Kong

Hungary

Israel

Japan

Luxembourg

Malaysia

Montenegro

New Zealand

Nicaragua

Norway

Peru

Poland

Portugal

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 OLYSIO around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4902361
Portugal	1912999
South Korea	20070009571	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	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
1912999	PA2014036	Lithuania		PRODUCT NAME: SIMEPREVIRUM; REGISTRATION NO/DATE: EU/1/14/924 20140514

Market Dynamics and Financial Trajectory for Olysio

Introduction

Olysio, also known as simeprevir, is a protease inhibitor used in the treatment of Hepatitis C Virus (HCV) infection. Developed by Janssen, the pharmaceutical arm of Johnson & Johnson, Olysio has been a significant player in the HCV treatment market, but its trajectory is influenced by several market dynamics and competitive factors.

Approval and Initial Success

Olysio was approved by the FDA in 2013 for the treatment of HCV, specifically in combination with Sovaldi (sofosbuvir) and sometimes with ribavirin. This approval marked a significant milestone in HCV treatment, offering patients an interferon-free regimen[4].

Market Performance

In its initial years, Olysio saw substantial sales. For instance, in the second quarter of its launch year, Olysio generated $831 million in sales, setting it on course to clear $2 billion in its first full year on the market. This pent-up demand was driven by the need for effective HCV treatments among patients[5].

Competitive Landscape

The HCV treatment market is highly competitive, and Olysio faces significant challenges from other pharmaceutical companies. Gilead Sciences, with its combination pill Harvoni (sofosbuvir and ledipasvir), poses a major threat. Harvoni, approved shortly after Olysio, combines two drugs into one pill, making it a more convenient option for patients. Additionally, AbbVie's three-drug combo was another competitor that entered the market, further intensifying the competition[4][5].

Pricing and Cost

Olysio is one of the more expensive treatments for HCV. The projected cost of Olysio is approximately $23,600 per month, with treatment periods ranging from 24 to 48 weeks. This high cost, similar to other antiviral drugs like Sovaldi, strains healthcare budgets and limits access, especially in low- and middle-income countries[1].

Market Dynamics and Price Stability

Despite the high costs, the HCV market dynamics suggest that significant price erosion is unlikely in the near future. The disease prevalence and high treatment rates in many countries, combined with low incidence rates and high sustained virologic response (SVR) rates achieved by current direct-acting antivirals (DAAs), mean that the patient population seeking treatment is decreasing. This stability in patient numbers, along with the fact that none of the currently marketed DAAs will lose patent protection in the next decade, supports the premium pricing of new pan-genotypic drugs[3].

Regional Impact

The global antiviral drugs market, including Olysio, is influenced by regional factors. North America, particularly the U.S., is a significant market due to the launch of effective products and advanced production facilities. However, the Asia Pacific region is expected to grow at the fastest rate during the forecast period, driven by an increasing geriatric population, improving healthcare infrastructure, and the entry of new players[1].

Financial Trajectory

The financial performance of Olysio has been impacted by the competitive landscape and market dynamics. While it saw initial success with high sales figures, the competition from other drugs, especially Harvoni, has posed significant challenges. Johnson & Johnson's CEO, Alex Gorsky, acknowledged that the pace of growth for Olysio would not be sustainable due to upcoming competition. The sales of Olysio have been overshadowed by the fading sales of J&J's former hepatitis C blockbuster Incivo (telaprevir), which fell more than 45% in the first half of the year[5].

Distribution and Access

The distribution of Olysio, like other antiviral drugs, is primarily through hospital pharmacies, which held the largest share of the overall revenue in 2022. Hospital pharmacies focus on improving supply chain management to ensure a consistent supply of antiviral drugs, especially during global health emergencies[1].

Future Outlook

The future outlook for Olysio is complex. While it remains an effective treatment for HCV, the market is expected to decline due to the surge in COVID-19 drug sales and the subsequent decline in demand for other antiviral drugs. However, the increasing prevalence of viral diseases and the growing awareness about vaccines could have a positive impact on the market. The introduction of generic versions of antiviral medicines may also affect Olysio's market share, although the lack of patent expiration for current DAAs in the near future suggests that Olysio will maintain its premium pricing[1].

Key Takeaways

• Initial Success: Olysio saw significant sales in its initial years due to pent-up demand for effective HCV treatments.
• Competitive Challenges: The drug faces intense competition from Gilead's Harvoni and AbbVie's three-drug combo.
• Pricing: Olysio is expensive, with a monthly cost of $23,600, straining healthcare budgets.
• Market Dynamics: The HCV market is stable in terms of pricing due to disease prevalence and patent protection.
• Regional Impact: North America and the Asia Pacific are key regions influencing the market.
• Financial Trajectory: Olysio's sales have been impacted by competition, and its growth is not expected to be sustainable.

FAQs

What is Olysio used for?

Olysio, or simeprevir, is used in the treatment of Hepatitis C Virus (HCV) infection, typically in combination with other drugs like Sovaldi and ribavirin.

How expensive is Olysio?

The projected cost of Olysio is approximately $23,600 per month, with treatment periods ranging from 24 to 48 weeks.

What are the main competitors to Olysio?

The main competitors to Olysio include Gilead's Harvoni (sofosbuvir and ledipasvir) and AbbVie's three-drug combo.

Why is the pricing of Olysio stable despite competition?

The pricing of Olysio remains stable due to the disease prevalence, high treatment rates, and the fact that none of the currently marketed DAAs will lose patent protection in the near future.

How does the regional market impact Olysio's sales?

North America, particularly the U.S., and the Asia Pacific region are significant markets for Olysio, with the latter expected to grow at the fastest rate due to an increasing geriatric population and improving healthcare infrastructure.

Sources

1. Grand View Research: Antiviral Drugs Market Size, Share & Growth Report, 2030
2. Olympus Global: Consolidated Financial Results for Fiscal 2024 and Full-Year
3. Drug Development & Delivery: Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies
4. HepFree NYC: Olysio-Sovaldi Combo Becomes 2nd FDA-approved All-oral HCV Treatment
5. PMLiVE: Olysio leads charge at J&J but competition is on the way