Sofosbuvir - Generic Drug Details

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

Sofosbuvir is the generic ingredient in four branded drugs marketed by Gilead Sciences Inc and Teva Pharms Usa Inc, and is included in six NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir has three hundred and sixty-two patent family members in forty-eight countries.

There are nine drug master file entries for sofosbuvir. One supplier is listed for this compound.

Summary for sofosbuvir

International Patents:	362
US Patents:	22
Tradenames:	4
Applicants:	2
NDAs:	6
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	323
Patent Applications:	1,594
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sofosbuvir
What excipients (inactive ingredients) are in sofosbuvir?	sofosbuvir excipients list
DailyMed Link:	sofosbuvir at DailyMed

Recent Clinical Trials for sofosbuvir

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

Sponsor	Phase
UNITAID	Early Phase 1
Médecins du Monde	Early Phase 1
International Network of People who Use Drugs	Early Phase 1

See all sofosbuvir clinical trials

Pharmacology for sofosbuvir

Drug Class	Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	RNA Replicase Inhibitors

Medical Subject Heading (MeSH) Categories for sofosbuvir

Antiviral Agents

Anatomical Therapeutic Chemical (ATC) Classes for sofosbuvir

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

Paragraph IV (Patent) Challenges for SOFOSBUVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SOVALDI	Tablets	sofosbuvir	400 mg	204671	2	2017-12-06

US Patents and Regulatory Information for 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	SOVALDI	sofosbuvir	TABLET;ORAL	204671-002	Aug 28, 2019		RX	Yes	No
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No					Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-001	Dec 6, 2013		RX	Yes	Yes					Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	PELLETS;ORAL	212480-002	Aug 28, 2019		RX	Yes	Yes					Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-001	Dec 6, 2013		RX	Yes	Yes
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-002	Aug 28, 2019		RX	Yes	No					Y

EU/EMA Drug Approvals for sofosbuvir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Sovaldi	sofosbuvir	EMEA/H/C/002798 Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.	Authorised	no	no	no	2014-01-16

International Patents for sofosbuvir

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4282482	Promédicaments de phosphoramidate de nucléoside (Nucleoside phosphoramidate prodrugs)
European Patent Office	2709613	PROCÉDÉS PERMETTANT DE TRAITER LE VIRUS DE L'HÉPATITE C (HCV) (METHODS FOR TREATING HCV)
Canada	2763151	ESTER DE N-[(2 ' R) -2' -DESOXY-2' -FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL]-L-ALANINE 1-METHYLETHYLE ET SON PROCEDE DE PRODUCTION (N- [(2'R) -2'-DEOXY-2'-FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION)
New Zealand	603232	Nucleoside phosphoramidates
Israel	239115	N-[(2'-r)-2'-דאוקסי-2'-פלואורו-2'-מתיל-p-פניל-5'-אורידיליל]-l-אלאנינ-1-מתילאתילאסטר ותהליך להכנתו (N-[(2'r)-2'-deoxy-2'-fluoro-2'-methyl-p-phenyl-5'-uridylyl]-l-alanine 1-methylethyl ester and process for its production)
Portugal	2432792

Supplementary Protection Certificates for sofosbuvir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	C02203462/01	Switzerland		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
2203462	300704	Netherlands		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2203462	1490066-6	Sweden		PRODUCT NAME: SOFOSBUVIR
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	14C0082	France		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117

Sofosbuvir Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Sofosbuvir

Introduction to Sofosbuvir

Sofosbuvir, marketed under the brand name Sovaldi, is a groundbreaking antiviral drug developed by Gilead Sciences. It is primarily used for the treatment of hepatitis C virus (HCV) infection. The drug has revolutionized the treatment landscape for HCV, offering a highly effective and relatively convenient therapy option compared to traditional treatments.

Market Size and Growth Projections

The global Sofosbuvir market is anticipated to experience significant growth over the forecast period from 2024 to 2031. The market size is expected to expand at a remarkable compound annual growth rate (CAGR), driven by increasing demand for effective HCV treatments and the drug's high efficacy rates[1][4].

Historical Context and Current Market

Since its approval in 2013, Sofosbuvir has achieved unprecedented success. In its first full year on the market, Sovaldi generated sales well over $11 billion, far exceeding initial predictions. This success contributed to Gilead Sciences' total revenues increasing by over 110% in the first half of 2014 compared to the same period in 2013[3].

Forecasted Market Dynamics

The market is segmented based on type (purity levels), application (adult and elderly patients), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). These segments are expected to contribute to the robust growth of the Sofosbuvir market, with Asia-Pacific and North America being key drivers due to their large patient populations and advanced healthcare systems[1][4].

Financial Trajectory

Revenue and Sales

The financial performance of Sofosbuvir has been stellar since its launch. In the first six months of 2014, Gilead Sciences' revenues surged from $5.3 billion in 2013 to $11.5 billion, primarily due to the record uptake of Sovaldi. This drug has been a high-value asset for Gilead, contributing significantly to the company's operating margin gains. The operating margin for Gilead reached over 60% in 2014, significantly higher than the industry average[3].

Cost of Goods Sold (COGS) and Operational Efficiency

The success of Sofosbuvir is also reflected in its cost structure. Despite being a high-priced drug, Sovaldi is relatively inexpensive to manufacture. This has led to a significant reduction in Gilead's COGS margin, which has been cut in half. Additionally, the Selling, General, and Administrative Expenses (SG&A) margin has decreased, contributing to the company's improved operational efficiency[3].

Drivers of Market Growth

High Efficacy Rates

Sofosbuvir-based regimens have shown exceptional efficacy in treating HCV, with sustained virologic response (SVR) rates exceeding 99% in many cases. This high efficacy has been a major driver of the drug's adoption and market growth[2].

Convenience and Safety

Compared to traditional treatments like pegylated interferon (pegIFN) and ribavirin (RBV), Sofosbuvir offers a more convenient and safer treatment option. It is administered orally and has a lower incidence of serious adverse events, making it a preferred choice for patients and clinicians alike[2].

Economic Viability

Cost-utility analyses have shown that Sofosbuvir-based regimens, particularly SOF/LDV, are cost-effective compared to traditional treatments. These regimens create more quality-adjusted life years (QALYs) while incurring lower costs, making them economically viable for healthcare systems[2].

Restraints and Challenges

Pricing and Reimbursement

Despite its clinical benefits, the high retail price of Sovaldi ($84,000 per year in the US) has been a significant barrier to access. Payers have been under pressure to reimburse these high-priced therapies, which can limit market growth[3].

Emerging Competition

The HCV market is becoming increasingly competitive with the entry of new drugs from companies like AbbVie, Bristol Myers-Squibb, and Merck & Co. This competition could challenge Gilead's dominance in the market[3].

Opportunities and Future Outlook

Expanding Patient Base

The global prevalence of HCV infection provides a large and expanding patient base for Sofosbuvir. As awareness and screening programs improve, more patients are likely to be diagnosed and treated, driving market growth[1].

Technological Advancements

Continuous technological advancements in the pharmaceutical industry could lead to improved formulations or combination therapies involving Sofosbuvir, further enhancing its market position[4].

Regulatory and Policy Support

Supportive regulatory environments and healthcare policies that promote access to innovative treatments can also contribute to the sustained growth of the Sofosbuvir market[4].

Competitive Scenario

Key Players

Gilead Sciences is the dominant player in the Sofosbuvir market, but other companies like Biogen Idec, AbbVie, and Bristol Myers-Squibb are also significant competitors. The competitive landscape is dynamic, with companies continuously innovating and expanding their product portfolios[3][4].

Market Strategies

Companies are focusing on improving operational efficiency, reducing costs, and enhancing patient access through various market strategies. This includes negotiating with payers, expanding into new markets, and developing combination therapies[3].

Regional Analysis

North America and Europe

These regions are among the largest markets for Sofosbuvir due to their advanced healthcare systems and high prevalence of HCV infection. The US, in particular, has been a key driver of the drug's sales[1][4].

Asia-Pacific

The Asia-Pacific region is expected to be a significant growth driver in the future, driven by large patient populations and increasing healthcare expenditure in countries like China and India[1][4].

Conclusion

The Sofosbuvir market is poised for significant growth driven by its high efficacy, convenience, and economic viability. Despite challenges related to pricing and emerging competition, the market is expected to expand substantially over the forecast period.

Key Takeaways

• High Efficacy Rates: Sofosbuvir-based regimens have shown exceptional efficacy in treating HCV.
• Convenience and Safety: The drug offers a more convenient and safer treatment option compared to traditional therapies.
• Economic Viability: Cost-utility analyses have shown that Sofosbuvir-based regimens are cost-effective.
• Pricing and Reimbursement: High retail prices remain a significant barrier to access.
• Emerging Competition: The HCV market is becoming increasingly competitive.
• Expanding Patient Base: The global prevalence of HCV infection provides a large and expanding patient base.

FAQs

What is Sofosbuvir used for?

Sofosbuvir is primarily used for the treatment of hepatitis C virus (HCV) infection.

How effective is Sofosbuvir in treating HCV?

Sofosbuvir-based regimens have shown exceptional efficacy, with sustained virologic response (SVR) rates exceeding 99% in many cases.

What are the main drivers of the Sofosbuvir market?

The main drivers include high efficacy rates, convenience and safety of the treatment, and economic viability.

What are the challenges facing the Sofosbuvir market?

Challenges include high pricing and reimbursement issues, as well as emerging competition from other pharmaceutical companies.

Which regions are expected to drive the growth of the Sofosbuvir market?

North America, Europe, and the Asia-Pacific region are expected to be key drivers of the market growth.

How has Sofosbuvir impacted Gilead Sciences' financial performance?

Sofosbuvir has significantly contributed to Gilead Sciences' revenue growth, operating margin gains, and reduced COGS and SG&A margins.

Sources

1. Market Research Intellect: Global Sofosbuvir Market Size, Trends and Projections[1].
2. Frontiers in Public Health: Cost-Effectiveness Analysis of Pan-Genotypic Sofosbuvir-Based Regimens[2].
3. Drug Development: Unprecedented Uptake of Sovaldi & Tecfidera Paves the Way for New Optimism in Pharma[3].
4. Cognitive Market Research: Global Sofosbuvir Market Report 2024 Edition[4].