Daclatasvir dihydrochloride - Generic Drug Details

What are the generic sources for daclatasvir dihydrochloride and what is the scope of freedom to operate?

Daclatasvir dihydrochloride is the generic ingredient in one branded drug marketed by Bristol-myers Squibb and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Daclatasvir dihydrochloride has ninety-three patent family members in thirty-one countries.

There are five drug master file entries for daclatasvir dihydrochloride.

Summary for daclatasvir dihydrochloride

International Patents:	93
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	127
Patent Applications:	1,327
DailyMed Link:	daclatasvir dihydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for daclatasvir dihydrochloride

Constraining patent/regulatory exclusivity:

8,629,171

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 daclatasvir dihydrochloride

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

Sponsor	Phase
Tanta University	Phase 3
Ain Shams University	Phase 3
Queen Mary University of London	N/A

See all daclatasvir dihydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for daclatasvir dihydrochloride

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 daclatasvir dihydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-001	Jul 24, 2015		DISCN	Yes	No	9,421,192			Y
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		DISCN	Yes	No	9,421,192			Y
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		DISCN	Yes	No	8,329,159			Y

International Patents for daclatasvir dihydrochloride

Country	Patent Number	Title	Estimated Expiration
China	101778840	Crystalline form of methyl ((1s)-1-(((2s)-2-(5-(4'-(2-((2s)-1-((2s)-2-((methoxycarbonyl)amino)-3-methylbutanoyl)-2-pyrrolidinyl)-1h-imidazol-5-yl)-4-biphenylyl)-1h-imidazol-2-yl)-1-pyrrolidinyl)carbonyl)-2-methylpropyl)carbamate dihydrochloride salt
Poland	2049522
Taiwan	I432426

Supplementary Protection Certificates for daclatasvir dihydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049522	1590007-9	Sweden		PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 20140826
2049522	C 2015 003	Romania		PRODUCT NAME: DACLATASVIR SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTUIA, IN SPECIAL DACLATASVIR DICLORHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/14/939/001, EU/1/14/939/002, EU/1/14/939/003, EU/1/14/939/004; DATE OF NATIONAL AUTHORISATION: 20140822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/939/001, EU/1/14/939/002, EU/1/14/939/003, EU/1/14/939/004; DATE OF FIRST AUTHORISATION IN EEA: 20140822
2049522	CR 2015 00003	Denmark		PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140826

Market Dynamics and Financial Trajectory for Daclatasvir Dihydrochloride

Introduction

Daclatasvir, marketed under the brand name Daklinza, is a direct-acting antiviral (DAA) used in the treatment of chronic hepatitis C virus (HCV) infection. This article delves into the market dynamics and financial trajectory of daclatasvir, highlighting its impact, challenges, and future outlook.

Market Size and Growth

The hepatitis C market, driven significantly by advancements in DAAs like daclatasvir, is projected to grow substantially. As of 2023, the hepatitis C market size was valued at USD 18.0 billion and is expected to reach USD 47.1 billion by 2034, with a compound annual growth rate (CAGR) of 9.14% during 2024-2034[1].

Role of Daclatasvir in the Market

Daclatasvir has been a key player in the transformation of HCV treatment. It is used in combination with other medications, such as sofosbuvir, to treat HCV genotypes 1 and 3. The drug's efficacy, particularly in achieving high sustained virologic response (SVR) rates without the need for interferon or ribavirin, has significantly improved patient outcomes and market demand[5].

Pricing and Accessibility

The pricing of daclatasvir varies widely depending on the region and economic development of the country. For instance, a 12-week course of daclatasvir can cost around $63,000 in the US, while it is significantly cheaper in countries like Egypt, where it costs around $525. This differential pricing strategy aims to make the drug more accessible in low- and middle-income countries[2].

Generic Competition and Price Reduction

The introduction of generic versions of daclatasvir and sofosbuvir has led to a significant reduction in prices. In India, for example, the price per 28-day supply of sofosbuvir dropped by 75% and daclatasvir by 60% between 2016 and 2018. This has made the fixed-dose combination of sofosbuvir and daclatasvir more affordable, with prices as low as $60 per patient for a 12-week course in some regions[3].

Competitive Landscape

The HCV market is highly competitive, with several major pharmaceutical companies involved. Bristol-Myers Squibb (BMS), the manufacturer of daclatasvir, faces competition from Gilead Sciences, Merck, and Janssen. Despite the efficacy of daclatasvir, BMS and other competitors have struggled to gain significant market share against Gilead's dominant position. However, the launch of new pan-genotypic treatments and improvements in treatment algorithms may offer opportunities for market penetration[4].

Financial Burden and Pricing Policies

The high list prices of DAAs, including daclatasvir, have been a subject of scrutiny. While the wholesale acquisition cost (WAC) for a 12-week treatment can be high (e.g., $63,000 for daclatasvir in the US), insurers often negotiate significant discounts. For instance, Gilead's average revenue per treatment for Sovaldi and Harvoni was estimated to be around $54,000 in 2015, and prices have continued to drop with the introduction of new competitors[4].

Global Outlook

The global HCV treatment landscape has undergone a significant transformation with the advent of DAAs. However, this success also presents challenges for pharmaceutical companies. The high treatment rates and low incidence rates of new HCV cases in many countries mean that the patient population seeking treatment is decreasing, which could impact future revenue streams. Despite this, the market is expected to remain competitive, with new pan-genotypic drugs likely to be priced at a premium relative to existing DAAs[4].

Clinical Success and Patient Outcomes

Daclatasvir, in combination with sofosbuvir, has achieved high SVR rates, exceeding 90% in many patient populations. This has led to improved patient adherence, reduced liver-related damage, and enhanced quality of life. The therapy is particularly beneficial for challenging-to-treat patients, including those with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV[5].

Regulatory and Approval Status

Daclatasvir was FDA-approved in July 2015 for use with sofosbuvir, with or without ribavirin, to treat HCV genotypes 1 and 3. It is also included in the World Health Organization's List of Essential Medicines, underscoring its importance in global health initiatives[2][5].

Future Market Trends

The HCV market is expected to continue its growth trajectory, driven by advancements in DAAs and increased accessibility of treatments. However, the market dynamics will be influenced by factors such as patent protection, generic competition, and the declining patient population. Companies will need to focus on simplifying treatment algorithms, improving efficacy for difficult-to-treat patients, and enhancing safety and tolerability to maintain market share[4].

Key Takeaways

• Market Growth: The hepatitis C market is projected to reach USD 47.1 billion by 2034, driven by DAAs like daclatasvir.
• Pricing and Accessibility: Daclatasvir's price varies globally, with significant reductions in low- and middle-income countries due to generic competition.
• Competitive Landscape: The market is highly competitive, with BMS facing challenges from Gilead and other competitors.
• Financial Burden: High list prices are mitigated by discounts negotiated by insurers.
• Clinical Success: Daclatasvir has achieved high SVR rates, improving patient outcomes and quality of life.

FAQs

What is daclatasvir used for?

Daclatasvir is a direct-acting antiviral used in combination with other medications to treat chronic hepatitis C virus (HCV) infection, particularly genotypes 1 and 3[5].

How much does daclatasvir cost?

The cost of daclatasvir varies widely depending on the country. For example, a 12-week course can cost around $63,000 in the US but as low as $525 in Egypt[2].

What are the key benefits of daclatasvir in HCV treatment?

Daclatasvir offers high sustained virologic response (SVR) rates, reduces the need for interferon or ribavirin, and improves patient outcomes, especially for challenging-to-treat patients[5].

How does generic competition affect the price of daclatasvir?

Generic competition has led to significant price reductions. For instance, the price per 28-day supply of sofosbuvir and daclatasvir has dropped substantially in countries like India[3].

What are the future market trends for daclatasvir and other DAAs?

The market is expected to grow, driven by advancements in DAAs, but will be influenced by factors such as patent protection, generic competition, and the declining patient population[4].

Sources

1. Biospace: Hepatitis C Market Estimated to Reach USD 47.1 Billion by 2034 ...
2. Wikipedia: Daclatasvir
3. Global Hepatitis Programme: Accelerating access to hepatitis C diagnostics and treatment
4. Drug Development & Delivery: Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies
5. DrugBank: Daclatasvir: Uses, Interactions, Mechanism of Action