Ledipasvir; sofosbuvir - Generic Drug Details

What are the generic sources for ledipasvir; sofosbuvir and what is the scope of freedom to operate?

Ledipasvir; sofosbuvir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ledipasvir; sofosbuvir has five hundred and fifty-five patent family members in forty-eight countries.

Two suppliers are listed for this compound.

Summary for ledipasvir; sofosbuvir

International Patents:	555
US Patents:	17
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	98
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ledipasvir; sofosbuvir
DailyMed Link:	ledipasvir; sofosbuvir at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ledipasvir; sofosbuvir

Dosage:

PELLETS;ORAL

Dosage:

TABLET;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 ledipasvir; sofosbuvir

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mansoura University	Phase 3
Helwan University	Phase 4
Cairo University	Phase 2/Phase 3

See all ledipasvir; sofosbuvir clinical trials

Pharmacology for ledipasvir; sofosbuvir

Drug Class	Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors RNA Replicase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ledipasvir; sofosbuvir

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 ledipasvir; sofosbuvir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-001	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes					Y

International Patents for ledipasvir; sofosbuvir

Country	Patent Number	Title	Estimated Expiration
Croatia	P20151075
Chile	2014000630	Una composicion que comprende 1) un compuesto derivado de nucleosido denominado como compuesto 10 y 2) un compuesto derivado de acido 5-tiofeno-2-carboxilico denominado como compuesto 5 o un compuesto derivado del ester metilico del acido carbamico denominado como compuesto 6; y su uso para el tratamiento profilactico o terapeutico de una infeccion por vhc.
Hungary	E034239
European Patent Office	2933260	PROMÉDICAMENTS À BASE DE PHOSPHORAMIDATES NUCLÉOSIDIQUES (NUCLEOSIDE PHOSPHORAMIDATE PRODRUGS)
Portugal	3309157
Spain	2927501
Brazil	PI1010795	compostos antivirais

Supplementary Protection Certificates for ledipasvir; sofosbuvir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2430014	PA2016002	Lithuania		PRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141118
2430014	1690002-9	Sweden		PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141118
2203462	122014000108	Germany		PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2203462	C02203462/01	Switzerland		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
2203462	PA2014040	Lithuania		PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	14C0082	France		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2430014	2016004	Norway		PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141203

Ledipasvir; sofosbuvir Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sofosbuvir/Ledipasvir (Harvoni)

Introduction

The combination of sofosbuvir and ledipasvir, marketed as Harvoni, has been a groundbreaking treatment for Hepatitis C virus (HCV) infection. Since its introduction, it has significantly impacted the pharmaceutical market and patient outcomes. Here, we delve into the market dynamics and financial trajectory of this drug.

Clinical Efficacy and Cost-Effectiveness

Sofosbuvir/ledipasvir has demonstrated high efficacy in treating HCV, particularly in treatment-naive and treatment-experienced patients. Studies have shown that this regimen is not only effective but also cost-effective in certain contexts.

• In Germany, the incremental cost-effectiveness ratio (ICER) for sofosbuvir/ledipasvir was found to be €3,383 per quality-adjusted life year (QALY) for cirrhotic patients, indicating it is cost-effective compared to the previous standard of care[2].
• In China, the ICER varied by economic region, but it was cost-effective in treatment-experienced patients with an ICER of US$21,612. However, the probability of cost-effectiveness was lower for treatment-naive patients, highlighting the need for price adjustments to make the treatment universally affordable[1].

Market Success and Revenue

The launch of sofosbuvir (Sovaldi) and its combination with ledipasvir (Harvoni) marked a significant milestone in the pharmaceutical industry.

• Gilead Sciences, the manufacturer, saw its revenues skyrocket with the introduction of Sovaldi and Harvoni. In the first half of 2014, Gilead's revenues increased by over 110% year-on-year, reaching $11.5 billion, primarily driven by the uptake of Sovaldi[3].
• The commercial success of these drugs was unprecedented, with Sovaldi generating over $11 billion in its first full year on the market, far exceeding the $11 billion Gilead paid to acquire sofosbuvir[3].

Pricing and Affordability

The high price of sofosbuvir/ledipasvir has been a significant factor in its market dynamics.

• In the US, Sovaldi was launched at a retail price of $84,000 per year, and Harvoni followed with a similar pricing strategy. Despite these high prices, the drugs achieved substantial commercial success due to their clinical benefits[3].
• However, affordability remains a critical issue. In China, for example, the price of a 12-week sofosbuvir/ledipasvir treatment would need to be reduced by at least 81% to make it cost-effective for all patients. The estimated affordable price would be around $105 for a full course of treatment[1].

Competitive Landscape

The HCV market has become highly competitive with multiple direct-acting antivirals (DAAs) available.

• Gilead Sciences has maintained a dominant position in the market, with Harvoni being a key product. Other companies like Bristol-Myers Squibb (Daklinza), Janssen (Olysio), and Merck (Zepatier) have also entered the market but face challenges in gaining significant market share due to the strong recommendations for Gilead's products by medical guidelines[4].
• The competitive landscape is expected to remain intense, with newly launching pan-genotypic drugs likely to be priced at a premium relative to existing DAAs. However, the stability in prices is anticipated due to the high treatment rates, low incidence rates, and the lack of generic competition in the near future[4].

Budget Impact and Affordability Analysis

The budget impact of sofosbuvir/ledipasvir is substantial, particularly for healthcare systems.

• In China, treating all eligible patients with sofosbuvir/ledipasvir would require significant resources, with an estimated budget of $522 billion to cover the drug costs for 10 million eligible patients. This highlights the need for careful pricing strategies to ensure affordability and accessibility[1].
• The World Health Organization (WHO) suggests that treatments costing one day’s wage or less for a full course are generally considered affordable. By this metric, sofosbuvir/ledipasvir is far from being affordable in many regions, necessitating price reductions or alternative access models[1].

Sensitivity and Probabilistic Analysis

Sensitivity analyses have been conducted to assess the robustness of the cost-effectiveness of sofosbuvir/ledipasvir.

• In Germany, sensitivity analyses confirmed the robustness of the results, showing that the probability of sofosbuvir/ledipasvir being cost-effective at a willingness-to-pay threshold of €30,000 was high, especially in treatment-experienced patients[2].
• In China, probabilistic sensitivity analysis indicated that the probability of cost-effectiveness varied significantly by region and patient type, emphasizing the need for region-specific pricing strategies[1].

Impact on Pharmaceutical Companies

The success of sofosbuvir/ledipasvir has had a profound impact on the financial performance of pharmaceutical companies.

• Gilead Sciences has seen significant operating margin gains due to the high-value and relatively low production costs of sofosbuvir. The company's operating margin has been well above the industry average, contributing to its financial success[3].
• Other companies, while struggling to match Gilead's market share, have still benefited from the overall growth in the HCV treatment market. However, they face ongoing challenges in competing with Gilead's strong product portfolio and pricing strategies[4].

Future Outlook

The future of sofosbuvir/ledipasvir in the market is influenced by several factors.

• Price Stability: The HCV market dynamics suggest that significant price erosion is unlikely in the near future. The stability in prices will be maintained due to the high treatment rates and the lack of generic competition[4].
• Competition: The competitive landscape will continue to evolve with new pan-genotypic drugs entering the market. However, Gilead's dominance is expected to persist due to its strong product portfolio and clinical recommendations[4].
• Affordability: Efforts to make sofosbuvir/ledipasvir more affordable will remain crucial. This could involve negotiations with healthcare systems, price reductions, or innovative access models to ensure broader accessibility[1].

Key Takeaways

• Sofosbuvir/ledipasvir has been highly effective in treating HCV, with significant clinical benefits.
• The drug has achieved unprecedented commercial success, driving substantial revenue growth for Gilead Sciences.
• Affordability remains a major challenge, with the need for significant price reductions to make the treatment accessible to all patients.
• The competitive landscape in the HCV market is intense, with Gilead maintaining a dominant position.
• Future market dynamics will be influenced by price stability, ongoing competition, and efforts to improve affordability.

FAQs

Q: How effective is sofosbuvir/ledipasvir in treating HCV? A: Sofosbuvir/ledipasvir has shown high efficacy in treating HCV, particularly in treatment-naive and treatment-experienced patients, with significant improvements in quality-adjusted life years (QALYs)[2].

Q: What is the current pricing strategy for sofosbuvir/ledipasvir? A: The current pricing of sofosbuvir/ledipasvir is high, with a retail price of around $84,000 per year in the US. This pricing has been a barrier to affordability in many regions[3].

Q: How does the cost-effectiveness of sofosbuvir/ledipasvir vary by region? A: The cost-effectiveness of sofosbuvir/ledipasvir varies significantly by region, with different economic regions having different ICERs and probabilities of cost-effectiveness. For example, in China, the probability of cost-effectiveness ranged from 15% to 64% depending on the region and patient type[1].

Q: What are the budget implications of treating HCV with sofosbuvir/ledipasvir? A: Treating all eligible patients with sofosbuvir/ledipasvir would require substantial budget allocations. In China, for instance, an estimated $522 billion would be needed to cover the drug costs for 10 million eligible patients[1].

Q: How does the competitive landscape affect the market for sofosbuvir/ledipasvir? A: The competitive landscape in the HCV market is intense, with Gilead Sciences maintaining a dominant position due to strong clinical recommendations and pricing strategies. Other companies face challenges in gaining significant market share[4].

Sources

1. PLOS ONE: "Will Sofosbuvir/Ledipasvir (Harvoni) Be Cost-Effective and Affordable in China? A Budget Impact and Affordability Analysis" [1].
2. PLOS ONE: "Cost-Effectiveness of Treating Hepatitis C with Sofosbuvir/Ledipasvir in Germany" [2].
3. Drug Development: "Unprecedented Uptake of Sovaldi & Tecfidera Paves the Way for New Optimism in Pharma" [3].
4. Drug Development: "Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies" [4].