simeprevir sodium - Profile

What are the generic drug sources for simeprevir sodium and what is the scope of freedom to operate?

Simeprevir sodium is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Simeprevir sodium has sixty-four patent family members in forty-one countries.

Summary for simeprevir sodium

International Patents:	64
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1

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

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.

US Patents and Regulatory Information for simeprevir sodium

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				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
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			Y	Y

Expired US Patents for simeprevir sodium

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 simeprevir sodium

Country	Patent Number	Title	Estimated Expiration
Spain	2555230
Portugal	1912999
Argentina	099345	INHIBIDORES MACROCÍCLICOS DEL VIRUS DE LA HEPATITIS C, COMPOSICIONES FARMACÉUTICAS QUE LOS COMPRENDEN, USO DE LOS MISMOS Y PROCESO PARA PREPARARLOS
Croatia	P20110237
Japan	4797067
Eurasian Patent Organization	015131	МАКРОЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ВИРУСА ГЕПАТИТА С (MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS)

Supplementary Protection Certificates for simeprevir sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
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
1912999	C20140034 00151	Estonia		PRODUCT NAME: SIMEPREVIIR;REG NO/DATE: EU/1/14/924 16.05.2014
1912999	PA2014036,C1912999	Lithuania		PRODUCT NAME: SIMEPREVIRAS; REGISTRATION NO/DATE: EU/1/14/924 20140514
1912999	204 5025-2014	Slovakia		FORMER OWNER(S): JANSSEN R&D IRELAND, IE; MEDIVIR AB, SE; DATUM ZAPISU DO REGISTRA: 20161206
1713823	CA 2014 00059	Denmark		PRODUCT NAME: SIMEPREVIR ELLER ET FARMACEUTISK SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140514

Investment Scenario and Fundamentals Analysis of Simeprevir Sodium

Last updated: February 10, 2026

What is Simeprevir Sodium?

Simeprevir sodium is an antiviral drug, a protease inhibitor approved for the treatment of hepatitis C virus (HCV) infection. Developed by Janssen Pharmaceuticals, it targets the NS3/4A protease—a key enzyme in HCV replication. Its primary indication was for combination therapy in genotype 1 HCV infection.

Market Overview and Competitive Position

The global hepatitis C market has declined since the advent of direct-acting antivirals (DAAs). Several blockbuster drugs, including sofosbuvir and ledipasvir, have achieved high cure rates reducing the demand for earlier therapies like simeprevir.

• Market Size: The hepatitis C drug market was valued at approximately $10.8 billion in 2019, declining due to newer drugs.
• Key Competitors: Sofosbuvir (Gilead Sciences), ledipasvir (Gilead), velpatasvir (Gilead), and combinations like Epclusa.
• Market Trends: The shift to pan-genotypic, interferon-free regimens with higher cure rates and shorter duration has rendered simeprevir less favorable.

Patent and Regulatory Data

• Patent Expiry: Janssen’s patent for simeprevir expired in the U.S. in 2019 and in Europe in 2021. Generic manufacturing is feasible post-expiry.
• Regulatory Status: Withdrawn from the U.S. market in 2018 due to declining sales and patent expiration. Remaining markets primarily include certain regions where the drug is still prescribed.

Development and Approval Pathway

Simeprevir was approved in 2013. It did not receive continued approval in the U.S. after 2018 due to declining use. No recent filings for new indications or formulations are noted, indicating limited future R&D focus on this compound.

Financial and Investment Fundamentals

Revenue and Sales Data

• Peak Sales: Estimated at $690 million in 2015 during its initial launch phase.
• Transition: Sales declined sharply post-2016 as new therapies entered the market.
• Current Revenue: Minimal or no ongoing revenue in major markets; some residual sales in select regions.

Patent Landscape and Generic Competition

With patents expiring, generic versions are available in several regions, driving down prices. This decreases profitability and reduces potential financial upside for rights holders.

R&D and Market Potential

The return on investment diminishes due to:

• Obsolete patent protection.
• Market share loss to newer, more effective therapies.
• Decreased prescription volumes.

Investment Risks and Outlook

Risks include:

• Further decline in sales due to generic competition.
• Limited pipeline development for simeprevir-related treatments.
• Regulatory withdrawal signals low future commercial potential.

Strategic Considerations for Investors

• Divestment: The drug’s business value has likely peaked; strategic divestment or licensing deals may be available.
• Patent Litigation and Licensing: Opportunities may exist in markets where the patent still holds or licensing for generic manufacturing.
• Pipeline Focus: Investors should monitor Janssen’s pipeline for hepatitis C or broad-spectrum antivirals for signs of renewed focus.

Conclusion

Simeprevir sodium presents limited investment prospects due to patent expiry, market decline, and competition from newer DAAs. The initial commercialization phase provided high revenue, but current fundamentals suggest minimal long-term growth potential. The key is to evaluate residual licensing income or market-specific opportunities in regions where the drug remains prescribed.

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Key Takeaways

• Simeprevir sodium’s global revenue has diminished to near negligible levels post-2018.
• Patent expiration and generics have eroded barriers to entry, intensifying price competition.
• Market shift to pan-genotypic drugs with higher cure rates has rendered simeprevir obsolete in key markets.
• Limited pipeline activity reduces future development prospects.
• Investment focus should shift toward newer antivirals or licensing opportunities rather than simeprevir itself.

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FAQs

1. Is there any ongoing research for simeprevir?
No prominent clinical trials or new indications are currently underway for simeprevir.

2. Can investors profit from licensing or generic manufacturing of simeprevir?
Potential exists in regions with licensing agreements or where patents are still active, but profitability is limited due to low market demand.

3. How does simeprevir compare to other hepatitis C drugs?
It was less effective and shorter-acting compared to newer pan-genotypic therapies with higher cure rates and fewer side effects.

4. What regulatory changes impacted simeprevir’s sales?
Withdrawal from the U.S. market in 2018 and patent expiry in 2019/2021 significantly limited commercial opportunities.

5. Should companies hold or divest simeprevir-related assets?
Given the declining market, divestment or licensing is advisable unless in specific emerging markets with residual demand.

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References

1. [1] Bloomberg Intelligence: Hepatitis C Market Report (2022).
2. [2] FDA approvals and withdrawal records.
3. [3] Janssen Pharmaceuticals Press Releases (2018–2022).
4. [4] PharmaMarketWatch: Viral Infectious Disease Therapeutics overview.
5. [5] PatentScope Database for patent expiry dates.