SOVALDI Drug Patent Profile

When do Sovaldi patents expire, and what generic alternatives are available?

Sovaldi is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in SOVALDI is sofosbuvir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir profile page.

DrugPatentWatch^® Generic Entry Outlook for Sovaldi

Sovaldi was eligible for patent challenges on December 6, 2017.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SOVALDI

International Patents:	362
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	34
Drug Prices:	Drug price information for SOVALDI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOVALDI
What excipients (inactive ingredients) are in SOVALDI?	SOVALDI excipients list
DailyMed Link:	SOVALDI at DailyMed

See drug prices for SOVALDI

Recent Clinical Trials for SOVALDI

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

Sponsor	Phase
Ain Shams University	Phase 3
Cairo University	Phase 3
Assiut University	Early Phase 1

See all SOVALDI clinical trials

Pharmacology for SOVALDI

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

Paragraph IV (Patent) Challenges for SOVALDI

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

US Patents and Regulatory Information for SOVALDI

SOVALDI is protected by nine US patents and five FDA Regulatory Exclusivities.

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	204671-001	Dec 6, 2013		RX	Yes	Yes					Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-002	Aug 28, 2019		RX	Yes	No
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
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-002	Aug 28, 2019		RX	Yes	No
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-002	Aug 28, 2019		RX	Yes	No					Y

EU/EMA Drug Approvals for SOVALDI

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 SOVALDI

When does loss-of-exclusivity occur for SOVALDI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SOVALDI around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1199645	含磷活性物質的立體選擇性合成 (STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES)
Poland	2552930
Ukraine	116087	КОМПОЗИЦІЯ ДЛЯ ЛІКУВАННЯ ВІРУСУ ГЕПАТИТУ C (METHODS FOR TREATING HCV)
Brazil	122013007556	compostos de fosforamidatos de nucleosídeo e processos para preparação destes compostos
Colombia	6630166	Síntesis esteroselectiva de activos que contienen fósforo
China	109776637	核苷氨基磷酸酯前药 (NUCLEOSIDE PHOSPHORAMIDATE PRODRUGS)

Supplementary Protection Certificates for SOVALDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	2014029	Norway		PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
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	CA 2014 00061	Denmark		PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
2203462	C20140035	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2203462	PA2014040,C2203462	Lithuania		PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	132014902310732	Italy		PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117

SOVALDI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Sovaldi

Introduction

Sovaldi, developed by Gilead Sciences, has been a game-changer in the treatment of hepatitis C (HCV) since its approval in December 2013. This drug has not only transformed the HCV treatment landscape but also had a significant impact on the pharmaceutical industry's market dynamics and financial performance.

Unprecedented Uptake and Sales

Sovaldi's launch was one of the most successful in pharmaceutical history. In its first quarter on the market, ending March 31, 2014, Sovaldi generated $2.27 billion in sales, making it the fastest-ever pharmaceutical launch[3].

• By the end of 2014, Sovaldi's sales had exceeded expectations, contributing to Gilead's total revenues increasing by over 110% year-on-year, from $5.3 billion in the first half of 2013 to $11.5 billion in the first half of 2014[1].
• For the full year 2014, Sovaldi's global sales were projected to reach $6.8 billion, a figure that was later surpassed with actual sales exceeding this estimate[3].

Financial Impact on Gilead Sciences

The success of Sovaldi had a profound financial impact on Gilead Sciences:

• Revenue Growth: Sovaldi's launch drove Gilead's revenues to nearly $25 billion in 2014, with net income of $12.1 billion. This was a significant increase from previous years, largely attributed to the sales of Sovaldi and its combination drug, Harvoni[2].
• Operating Margins: The high-value asset of Sovaldi, which is relatively inexpensive to produce, led to significant operating margin gains for Gilead. The company's Cost of Goods Sold (COGS) margin was cut in half, and its Selling, General, and Administrative Expenses (SG&A) margin decreased substantially despite increased commercial costs[1].
• Stock Performance: The success of Sovaldi and Harvoni contributed to Gilead's stock growth, with the company's stock price increasing by 157% over two calendar years following the introduction of these drugs[2].

Market Dynamics and Competition

The success of Sovaldi also influenced market dynamics and competition in the HCV treatment sector:

• Unmet Medical Need: Sovaldi addressed a significant unmet medical need in HCV treatment, offering unprecedented efficacy and tolerability compared to previous treatments like Merck’s Victrelis and Vertex’s Incivek. This led to a surge in HCV treatment rates[1].
• Competitive Landscape: Despite the dominance of Sovaldi, other companies like Bristol-Myers Squibb (BMS) and Janssen (Johnson & Johnson) entered the market with their own HCV treatments, such as Daklinza and Olysio. However, these products often required combination with Sovaldi, giving Gilead a competitive edge[4].
• Pricing and Access: The high price of Sovaldi ($84,000 per year) and Harvoni sparked debates about affordability and access. This led to pricing pressures and the emergence of competitors like AbbVie's Viekira Pak, which was selected by Express Scripts as a preferred treatment to undercut Gilead's prices[2][3].

Pricing Controversies and Access Issues

The pricing of Sovaldi was a contentious issue:

• High Pricing: Sovaldi's launch price was criticized for being unsustainable for healthcare systems. Despite this, the drug's clinical benefits justified its high price, leading to significant commercial success[1][3].
• Rationing Care: The high cost led to rationing of the drug, with some patients being told to wait for treatment until better options became available. This highlighted the ethical and financial challenges in providing access to expensive but effective treatments[3].

Long-Term Financial Trajectory

The financial trajectory of Sovaldi and its impact on Gilead Sciences has evolved over time:

• Peak Sales: Sovaldi's sales peaked in 2016, with projected sales of around $12 billion, before declining as other treatments entered the market and pricing pressures increased[3].
• Recent Financial Performance: While Sovaldi is no longer the dominant revenue driver it once was, Gilead's overall financial performance remains strong. In 2023, Gilead reported total revenues of $27.1 billion, though this was a slight decrease from 2022 due to lower sales of other products like Veklury (remdesivir)[5].

Key Takeaways

• Transformative Impact: Sovaldi transformed the HCV treatment landscape with its unprecedented efficacy and tolerability.
• Financial Success: The drug drove significant revenue and profit growth for Gilead Sciences.
• Market Dynamics: Sovaldi's success influenced market strategies and competition in the HCV sector.
• Pricing and Access: The high price of Sovaldi raised important questions about affordability and access to healthcare.
• Long-Term Trajectory: While Sovaldi's sales have declined, Gilead's financial performance remains robust.

FAQs

Q: What was the initial market response to Sovaldi upon its launch? A: Sovaldi's launch was highly successful, with sales of $2.27 billion in its first quarter, making it the fastest-ever pharmaceutical launch.

Q: How did Sovaldi impact Gilead Sciences' financial performance? A: Sovaldi significantly increased Gilead's revenues and net income, driving the company's total revenues to nearly $25 billion in 2014.

Q: What were the main competitors to Sovaldi in the HCV treatment market? A: Other competitors included Bristol-Myers Squibb's Daklinza and Janssen's Olysio, though these often required combination with Sovaldi.

Q: Why was the pricing of Sovaldi controversial? A: The high price of Sovaldi ($84,000 per year) raised concerns about affordability and access, leading to rationing and pricing pressures.

Q: What is the current financial status of Gilead Sciences in relation to Sovaldi? A: While Sovaldi is no longer the dominant revenue driver, Gilead's overall financial performance remains strong, with total revenues of $27.1 billion in 2023.

Sources

1. Drug Development: "Unprecedented Uptake of Sovaldi & Tecfidera Paves the Way for New Optimism in Pharma"
2. FiercePharma: "Gilead's Sovaldi, Harvoni push its full-year sales to $25B"
3. Pharmaceutical Commerce: "Sovaldi, the $1,000 pill"
4. Drug Development: "Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies"
5. Gilead Sciences: "Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results"