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:	128
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for daclatasvir dihydrochloride
DailyMed Link:	daclatasvir dihydrochloride at DailyMed

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

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
ANRS, Emerging Infectious Diseases	NA
Tanta University	Phase 3
Ain Shams University	Phase 3

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	206843-002	Jul 24, 2015		DISCN	Yes	No				Y
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		DISCN	Yes	No			Y	Y
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		DISCN	Yes	No

International Patents for daclatasvir dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Argentina	063684	DERIVADOS DE 4, 4´-BIFENILDIILBIS(1H-IMIDAZOL-5, 2-DIIL) COMO INHIBIDORES DEL VIRUS DE LA HEPATITIS C, COMPOSICION QUE LOS COMPRENDE Y SU USO PARA TRATAR UNA INFECCION CON VHC.
Argentina	108411	INHIBIDORES DEL VIRUS DE LA HEPATITIS C
Australia	2007286222	Hepatitis C virus inhibitors

Supplementary Protection Certificates for daclatasvir dihydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049522	524	Finland
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	9/2015	Austria		PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826

Market Dynamics and Financial Trajectory for Daclatasvir Dihydrochloride

Last updated: February 14, 2026

Overview

Daclatasvir dihydrochloride is a direct-acting antiviral (DAA) agent targeting hepatitis C virus (HCV). It is marketed in combination therapies, notably as Daklinza by Bristol-Myers Squibb. The drug's approval status varies globally, influencing its market penetration.

Market Size and Growth

The global HCV therapeutic market is projected to reach approximately $20 billion by 2027, with a compound annual growth rate (CAGR) of around 7% (Research and Markets, 2022). Daclatasvir's share within this largely depends on regional approval and competition.

In 2022, the estimated annual sales of Daclatasvir globally stood at approximately $1.2 billion, representing a significant segment of the HCV treatment market, although it faces stiff competition from other DAAs such as sofosbuvir-based regimens.

Regulatory Status and Regional Dynamics

• United States: The FDA approved Daklinza in 2015. Its use is limited to specific HCV genotypes, particularly genotype 3, with restrictions due to drug interactions.
• European Union: Approved in 2014, with several Member States including Daclatasvir in their formularies.
• Asia-Pacific: Regulatory approval varies, with Japan approving Daclatasvir for certain genotypes.
• Other markets: Some regions lack approval, limiting revenue potential.

Competitive Landscape

Daclatasvir competes primarily with sofosbuvir-based regimens (e.g., Harvoni) and other DAAs like glecaprevir/pibrentasvir. Its position is affected by:

• Efficacy: Daclatasvir exhibits high sustained virologic response (SVR) rates, especially in combination therapies.
• Pricing: Price negotiations and generic options influence market share.
• Patent Status: Bristol-Myers Squibb’s patents for Daklinza expire around 2024–2026 in key markets, opening opportunities for generic entrants.

Financial Trajectory and Revenue Drivers

• Current Revenue: Approximately $1.2 billion in 2022.
• Forecasted Revenue: Expected to decline gradually post-patent expiry due to generic competition and market saturation, projecting to around $0.6 billion by 2027.
• Pricing Trends: Price erosion is ongoing; in some markets, prices have fallen by up to 50% since launch.
• Market Penetration: Limited in markets where newer or more convenient combinations are preferred.

Factors Influencing Future Market Performance

• Patent Expiry: Begins around 2024–2026, enabling generic competition reducing prices.
• New Formulations: Lack of new patent-protected formulations limits growth.
• Regulatory Approvals: Expansion into new regions could boost sales.
• Treatment Guidelines: Shifts favoring pangenotypic, all-oral combination therapies diminish the use of Daclatasvir monotherapy.

Financial Outlook Summary

Metric	2022	2023	2024–2027 (Forecast)
Revenue (USD billions)	1.2	1.0	0.6–0.8
Market share	~10%	Decreasing	Continued decline post-patent expiry
Average selling price (ASP)	$1,200 per treatment course	Decreasing	Further decrease, especially post-generic entry

Key Market Drivers and Restraints

• Drivers: High efficacy in genotype 3, established safety profile, expanding use in various regions.
• Restraints: Patent expiration, competition from newer DAAs, pricing pressures, and evolving treatment guidelines that favor pangenotypic regimens.

Key Takeaways

• Daclatasvir's current market value centers around $1.2 billion annually, with growth slowing.
• Patent expiry around 2024–2026 is set to depress revenues as generics enter.
• Competition and regulatory dynamics heavily influence future sales.
• Limited pipeline development constrains long-term growth prospects.
• Regional approval gaps restrict global market expansion.

FAQs

1. What factors primarily contribute to Daclatasvir's revenue decline?
Patent expiry, generic competition, pricing erosion, and the shift toward pangenotypic treatments reduce market size and revenue.

2. How does regional regulatory status affect Daclatasvir sales?
Limited approvals restrict access, confining revenue to specific markets and reducing global revenue potential.

3. Are there new formulations of Daclatasvir in development?
No significant pipeline updates have been announced, limiting prospects for increased market share through formulation enhancements.

4. How does Daclatasvir compare with competitors?
It offers high efficacy in certain genotypes but is vulnerable to generic competition and is outperformed in some regions by newer, more convenient regimens.

5. What impact does patent expiration have on manufacturers?
It allows generic manufacturers to produce lower-cost versions, significantly eroding branded sales, especially in price-sensitive markets.

References

1. Research and Markets. (2022). Global Hepatitis C Virus (HCV) Therapeutics Market Size, Share & Trends Analysis Report.
2. Bristol-Myers Squibb. (2015). Daklinza official approval documents.
3. FDA. (2015). Daklinza approval announcement.
4. European Medicines Agency. (2014). Daclatasvir marketing authorization.
5. IQVIA. (2022). Pharma Market Analysis Reports.