Simeprevir sodium - Generic Drug Details

What are the generic drug sources for simeprevir sodium and what is the scope of patent protection?

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

Simeprevir sodium has one hundred and forty patent family members in forty-three countries.

Summary for simeprevir sodium

International Patents:	140
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	46
DailyMed Link:	simeprevir sodium at DailyMed

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

Constraining patent/regulatory exclusivity:

8,148,399

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.

Medical Subject Heading (MeSH) Categories for simeprevir sodium

Antiviral Agents

Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for simeprevir sodium

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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	7,671,032		Y	Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	8,148,399		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	9,856,265		Y	Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	8,754,106			Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	9,040,562		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	7,671,032

International Patents for simeprevir sodium

Country	Patent Number	Title	Estimated Expiration
Cyprus	1112006
Japan	4902361
South Korea	101217036
South Africa	200607214	HCV NS-3 SERINE PROTEASE INHIBITORS
Singapore	163617	MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS
Japan	2007524670

Supplementary Protection Certificates for simeprevir sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1912999	C01912999/01	Switzerland		PRODUCT NAME: SIMEPREVIR; REGISTRATION NO/DATE: SWISSMEDIC 63215 04.03.2015
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	204 5025-2014	Slovakia		FORMER OWNER(S): JANSSEN R&D IRELAND, IE; MEDIVIR AB, SE; DATUM ZAPISU DO REGISTRA: 20161206
1912999	PA2014036	Lithuania		PRODUCT NAME: SIMEPREVIRUM; REGISTRATION NO/DATE: EU/1/14/924 20140514
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Simeprevir Sodium

Last updated: July 27, 2025

Introduction

Simeprevir sodium, marketed under the brand name Olysio among others, is an orally administered protease inhibitor used in combination therapies for hepatitis C virus (HCV) infection. Approved by the U.S. Food and Drug Administration (FDA) in 2013, simeprevir’s significance lies in its targeted antiviral activity, which marked a notable advance in hepatitis C treatment. Nonetheless, with the rapidly evolving therapeutic landscape, understanding its current market dynamics and financial trajectory is crucial for stakeholders.

Overview of Simeprevir Sodium

Simeprevir sodium functions by inhibiting the NS3/4A protease essential for HCV replication. As part of a direct-acting antiviral (DAA) regimen, it was positioned as an alternative to interferon-based treatments, offering improved efficacy and tolerability. Typically used in combination with other antivirals like sofosbuvir, simeprevir contributed to high cure rates—up to 85-95%—particularly in genotype 1 HCV infections [1].

Market Dynamics

1. Competitive Landscape Evolution

Since its approval, simeprevir faced a swiftly transforming market environment. The emergence of next-generation DAAs, such as glecaprevir/pibrentasvir and velpatasvir/sofosbuvir, challenged its position. These newer agents offer broader genotypic coverage, shorter treatment durations, and fewer adverse effects [2].

The alternative therapies' superior efficacy and simplified regimens led to a decline in demand for simeprevir. Additionally, some formulations faced regulatory hurdles or manufacturing discontinuations as newer, fixed-dose combinations dominated the market.

2. Regulatory and Patent Considerations

Pfizer, the original developer, voluntarily withdrew simeprevir (brand Olysio) from the market in 2018, primarily due to reduced demand and the availability of better options [3]. The patent landscape also shifted, with patent expirations impacting exclusivity periods and generic entry, further attenuating profit margins.

3. Market Penetration and Geographic Factors

Initially, simeprevir achieved significant penetration in North America and Europe. However, as newer treatments gained approval, formulary restrictions and reimbursement policies shifted, limiting access. Developing countries exhibited limited uptake due to affordability and regulatory delays, constraining broader market expansion.

4. Pricing Strategies and Reimbursement Policies

Pricing of simeprevir was competitive at launch, aligning with market expectations for innovative antivirals. Nonetheless, health authorities in high-income countries negotiated substantial price reductions over time as competition intensified. Reimbursement policies increasingly favored combination therapies with proven superior efficacy and safety profiles, reducing the attractiveness of older agents like simeprevir.

5. Impact of COVID-19 Pandemic

The COVID-19 pandemic injected additional uncertainty, diverting healthcare resources and delaying hepatitis C screening and treatment programs. This downturn negatively influenced sales and delayed market recovery for residual simeprevir formulations [4].

Financial Trajectory

1. Revenue Trends

Following its peak post-approval, simeprevir experienced a steady decline in sales volume. Pfizer’s decision to exit the simeprevir market in 2018 reflects this contraction. Prior to withdrawal, annual sales in key markets ranged around several hundred million dollars; however, by 2017, revenues had declined markedly, undermined by competitive pressures and market saturation [5].

2. Cost of Goods Sold (COGS) and Profitability

Reduced sales volume, coupled with the withdrawal from active marketing and reduced promotional expenses, led to dwindling profit contributions from simeprevir. Manufacturing costs decreased over time, but fixed costs and patent-related expenses persisted until patent expiry, adversely impacting margins.

3. Patent and Generic Entry Impact

The patent landscape significantly affected financial prospects. Patent expiration or challenges facilitated entry of generic competitors in some jurisdictions, further eroding profitability potential. As Pfizer exited the market, the financial trajectory shifted from revenue growth to decline, driven largely by residual sales until market exhaustion.

4. Residual Market and Licensing

While Pfizer ceased direct marketing, licensing agreements or third-party sales in emerging markets may sustain limited residual revenues. However, these are insufficient to counter the overarching downward trajectory driven by newer therapies.

Current and Future Market Outlook

Given Pfizer's withdrawal, the immediate outlook for simeprevir is predominantly de minimis. Its role remains confined in niche markets or as part of salvage therapy, with the broader hepatitis C market dominated by highly efficacious, pan-genotypic agents. Nonetheless, residual interest persists for formulation-specific or research applications, though commercial viability appears minimal.

Strategic Insights for Stakeholders

• Pharmaceutical companies should recognize the rapid obsolescence of hepatitis C treatments post-launch, emphasizing pipeline innovation.
• Investors should evaluate declining revenue streams and patent expirations influencing long-term valuation.
• Healthcare policymakers should prioritize access to newer, more effective therapies, reducing reliance on older agents like simeprevir.

Key Market Segments

• Emerging Markets: Limited penetration; potential for generic or biosimilar development, but constrained by low demand.
• Developed Markets: Significantly diminished sales post-2018; residual revenue mainly from contractual or niche uses.
• Research & Development: Limited ongoing clinical development involving simeprevir due to obsolescence.

Regulatory Considerations

Regulatory bodies have largely phased out approval statuses of older hepatitis C agents as new therapeutics supersede them. Pfizer’s active withdrawal reflects this trend. Any residual licensing or off-label use is carefully monitored and declining.

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Key Takeaways

• The market for simeprevir sodium has experienced a sharp decline, driven by competition from superior, pan-genotypic DAAs and patent expirations.
• Pfizer’s withdrawal in 2018 signals the conclusion of its commercial viability, with residual revenues expected to diminish rapidly.
• Market dynamics illustrate the importance of continuous innovation and adaptation within pharmaceutical therapeutics, especially for rapidly evolving indications like hepatitis C.
• Future prospects for simeprevir are limited; focus has shifted toward next-generation therapies, rendering older agents obsolete in mainstream treatment guidelines.
• Stakeholders should prioritize pipeline development and market adaptation strategies aligned with current standard-of-care paradigms.

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FAQs

1. Why did Pfizer withdraw simeprevir from the market?
Pfizer withdrew simeprevir mainly due to declining sales, heightened competition from newer DAAs with better efficacy profiles, and strategic market realignment, aligning with their focus on more profitable therapeutic areas [3].

2. What factors led to the decline in simeprevir’s market share?
The advent of pan-genotypic DAAs, improved safety profiles, simplified regimens, patent expirations, and regulatory shifts rendered simeprevir less attractive, causing its market share to plummet [2].

3. Are there any remaining patents protecting simeprevir?
Most patent protections have expired or faced patent challenges in major markets, facilitating generic entry and further diminishing the drug’s commercial prospects [5].

4. Can simeprevir still be used in hepatitis C treatment today?
While off-label or salvage use may occur, simeprevir is largely obsolete in standard treatment protocols, replaced by more effective, pan-genotypic agents.

5. What lessons can pharmaceutical companies learn from simeprevir’s market trajectory?
Innovation, timely adaptation to evolving standards of care, and proactive patent management are critical. Reliance on first-generation agents in rapidly advancing therapeutic areas risks obsolescence.

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References

[1] US Food and Drug Administration. (2013). FDA Approves Simeprevir for Hepatitis C.

[2] European Medicines Agency. (2014). Summary of Product Characteristics for Olysio.

[3] Pfizer Inc. Press Release. (2018). Discontinuation of Olysio in select markets.

[4] World Health Organization. (2021). Hepatitis C: Global epidemiology and treatment access issues.

[5] MarketLine. (2017). Pharmaceutical Industry Profile: Hepatitis C Virus Treatments.