Simeprevir sodium - Generic Drug Details

What are the generic 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 thirty-nine patent family members in forty-three countries.

Summary for simeprevir sodium

International Patents:	139
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	46
Patent Applications:	1,708
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	9,040,562		Y	Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	9,623,022
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	7,671,032		Y	Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	9,856,265		Y	Y

International Patents for simeprevir sodium

Country	Patent Number	Title	Estimated Expiration
Ukraine	84050	ІНГІБІТОРИ СЕРИН-ПРОТЕАЗИ NS-3 HCV[ИНГИБИТОРЫ СЕРИН-ПРОТЕАЗЫ NS-3 HCV (HCV NS-3-SERINE PROTEASE INHIBITORS)
Poland	2322516
European Patent Office	1912999	INHIBITEURS MACROCYCLIQUES DU VIRUS DE L'HÉPATITE C (MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS)
Japan	2011140488	HCV NS-3 SERINE PROTEASE INHIBITOR
Slovenia	1713823

Supplementary Protection Certificates for simeprevir sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713823	92595	Luxembourg		PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 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	122014000098	Germany		PRODUCT NAME: SIMEPREVIR ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/924 20140514
1912999	CA 2014 00053	Denmark		PRODUCT NAME: SIMEPREVIR ELLER ET SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140514
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

Simeprevir sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Simeprevir Sodium

Introduction to Simeprevir Sodium

Simeprevir sodium, marketed under the brand name Olysio, is a nonstructural protein 3 (NS3)/4A protease inhibitor used in the treatment of chronic hepatitis C (CHC) genotype 1 and genotype 4 infections. It is administered in combination with other medicinal products such as pegylated interferon and ribavirin (PR)[4].

Clinical Efficacy and Market Position

Clinical Trials and Efficacy

Simeprevir has demonstrated significant efficacy in clinical trials. Phase 2b studies (C205 and C206) showed that simeprevir 150 mg once daily (QD) provided higher sustained virologic response rates (SVR) compared to lower doses, particularly in harder-to-treat patient subgroups such as those with the HCV Q80K mutation or more severe liver fibrosis and inflammation[1].

In Phase 3 trials, simeprevir in combination with PR consistently demonstrated superior efficacy to PR therapy alone, with SVR rates significantly higher in both treatment-naive and treatment-experienced patients[1].

Market Impact

The introduction of simeprevir and other direct-acting antivirals (DAAs) has revolutionized the treatment landscape for HCV, offering higher cure rates and fewer contraindications compared to traditional therapies. This shift has increased demand for these newer treatments, despite their higher costs[2].

Cost-Effectiveness and Financial Considerations

Cost-Effectiveness Analysis

Studies have shown that while new HCV treatments, including simeprevir, are cost-effective per person treated, they pose significant financial challenges due to the high costs and pent-up demand for treatment. For instance, treating HCV with simeprevir and sofosbuvir increased quality-adjusted life-years (QALYs) and reduced deaths, but at an incremental cost of $80.1 billion, with an incremental cost-effectiveness ratio (ICER) of $72,169 per QALY gained[2].

Manufacturing and Pricing

The manufacturing costs of simeprevir are relatively high due to the complexity of its chemical synthesis. Predicted manufacturing costs for a 12-week course of simeprevir range from $130 to $270. However, large-scale manufacture could reduce these costs, making widespread access to HCV treatment more feasible, especially in low- and middle-income countries[3].

Market Pricing

At the time of its launch, the US price for a 12-week treatment course of simeprevir was approximately $66,000, which is significantly higher than the estimated minimum manufacturing costs. This pricing has been a barrier to access in many regions, particularly in low- and middle-income countries where the cost of treatment is a major constraint[3].

Financial Trajectory

Revenue and Sales

The financial trajectory of simeprevir has been influenced by its clinical efficacy, market demand, and competition from other DAAs. Initially, simeprevir generated significant revenue due to its superior efficacy and the lack of alternative treatments. However, the market has become increasingly competitive with the introduction of other DAAs and combination therapies.

Competition and Market Share

The HCV treatment market has seen a rapid evolution with multiple DAAs entering the market. Simeprevir, while effective, faces competition from other treatments like sofosbuvir and combination regimens such as Viekira Pak and Harvoni. This competition has impacted the market share of simeprevir, as healthcare providers and patients opt for newer, potentially more convenient, and sometimes more cost-effective options[2].

Access and Affordability

Efforts to improve access and affordability are ongoing. Large-scale manufacturing and generic versions could reduce costs, making simeprevir more accessible globally. However, current pricing remains a significant barrier, especially in regions with limited healthcare budgets[3].

Regulatory and Pharmacovigilance Aspects

Regulatory Approval

Simeprevir was approved by regulatory bodies such as the FDA and the Australian Therapeutic Goods Administration (TGA) for the treatment of CHC genotype 1 and genotype 4 infections. The approval process was based on extensive clinical data demonstrating its efficacy and safety profile[1][4].

Risk-Benefit Assessment

The risk-benefit assessment of simeprevir highlights its efficacy but also notes potential drug interactions and side effects. Simeprevir can affect and be affected by a wide range of drugs, necessitating careful management in patients with multiple medications[4].

Future Outlook

Evolving Treatment Landscape

The HCV treatment landscape continues to evolve with new therapies and combination regimens being developed. Simeprevir, while an important part of this landscape, must compete with newer treatments that offer potentially better efficacy, convenience, and cost profiles.

Global Access Initiatives

Initiatives to reduce the cost of HCV treatments, including simeprevir, are crucial for increasing global access. Large-scale manufacturing, generic versions, and public health programs aimed at reducing treatment costs could make simeprevir more accessible in the future[3].

Key Takeaways

• Clinical Efficacy: Simeprevir has demonstrated high efficacy in treating CHC, particularly in combination with PR.
• Cost-Effectiveness: Despite high costs, simeprevir is cost-effective per person treated but poses financial challenges due to pent-up demand.
• Market Dynamics: The market is highly competitive with multiple DAAs available, impacting simeprevir's market share.
• Regulatory and Safety: Simeprevir has been approved by regulatory bodies but requires careful management due to potential drug interactions.
• Future Outlook: Global access initiatives and large-scale manufacturing could improve affordability and access to simeprevir.

FAQs

Q: What is simeprevir used for?

A: Simeprevir is used for the treatment of chronic hepatitis C (CHC) genotype 1 and genotype 4 infections, typically in combination with other medicinal products.

Q: How effective is simeprevir in treating HCV?

A: Simeprevir has shown high efficacy in clinical trials, particularly in harder-to-treat patient subgroups, with sustained virologic response rates significantly higher than traditional therapies.

Q: Why is simeprevir expensive?

A: The high cost of simeprevir is due to the complexity of its chemical synthesis and the current market pricing, which is significantly higher than the estimated minimum manufacturing costs.

Q: How does simeprevir compare to other HCV treatments?

A: Simeprevir faces competition from other DAAs and combination regimens, which may offer better efficacy, convenience, and cost profiles.

Q: What are the potential side effects and interactions of simeprevir?

A: Simeprevir can affect and be affected by a wide range of drugs, and it has potential side effects, necessitating careful management in patients with multiple medications[4].

Sources

1. FDA Clinical Pharmacology Review: "205123Orig1s000 - accessdata.fda.gov"
2. Cost-Effectiveness Study: "The cost-effectiveness, health benefits, and financial costs of new treatments for hepatitis C virus infection" - PubMed
3. Manufacturing Costs Analysis: "Minimum Costs for Producing Hepatitis C Direct-Acting Antivirals for Global Access" - Academic.oup.com
4. Australian Public Assessment Report: "Australian public assessment report for simeprevir (as sodium)" - TGA.gov.au