DAKLINZA Drug Patent Profile

When do Daklinza patents expire, and when can generic versions of Daklinza launch?

Daklinza is a drug marketed by Bristol-myers Squibb and is included in one NDA. There are five patents protecting this drug.

This drug has ninety-three patent family members in thirty-one countries.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this compound. Additional details are available on the daclatasvir dihydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Daklinza

Daklinza was eligible for patent challenges on July 24, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 13, 2031. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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 DAKLINZA

International Patents:	93
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	13
Patent Applications:	93
Drug Prices:	Drug price information for DAKLINZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DAKLINZA
DailyMed Link:	DAKLINZA at DailyMed

See drug prices for DAKLINZA

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

NDA:

206843

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 DAKLINZA

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

Sponsor	Phase
Ain Shams University	Phase 3
Cairo University	Phase 3
Tanta University	Phase 2/Phase 3

See all DAKLINZA clinical trials

US Patents and Regulatory Information for DAKLINZA

DAKLINZA is protected by eight US patents.

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

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
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-001	Jul 24, 2015		DISCN	Yes	No				Y
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		DISCN	Yes	No				Y

International Patents for DAKLINZA

When does loss-of-exclusivity occur for DAKLINZA?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Peru

South Africa

South Korea

Spain

Taiwan

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 DAKLINZA around the world.

Country	Patent Number	Title	Estimated Expiration
Luxembourg	92635
Norway	340543
Canada	2660520	INHIBITEURS DU VIRUS DE L'HEPATITE C (HEPATITIS C VIRUS INHIBITORS)

Supplementary Protection Certificates for DAKLINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049522	122015000009	Germany		PRODUCT NAME: DACLATASVIR UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE DACLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939/001-004 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
2049522	9/2015	Austria		PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DAKLINZA (Daclatasvir)

Last updated: July 27, 2025

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Introduction

Daclatasvir (brand name: Daklinza), developed by Bristol-Myers Squibb, represents a novel direct-acting antiviral (DAA) agent, approved primarily for treating hepatitis C virus (HCV) infection. Since its approval, DAKLINZA has significantly influenced the HCV therapeutic landscape, creating dynamic shifts in market shares, pricing strategies, and competitive positioning. This report provides a comprehensive analysis of the current market dynamics and financial trajectory of DAKLINZA, emphasizing regulatory developments, competitive environment, market penetration strategies, and revenue prospects.

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Market Overview and Therapeutic Positioning

HCV Epidemiology and Market Demand
Globally, an estimated 58 million individuals suffer from chronic HCV infections, with substantial morbidity and mortality linked to HCV-related liver cirrhosis and hepatocellular carcinoma [1]. The increasing adoption of potent DAAs, including DAKLINZA, has revolutionized HCV management by achieving high cure rates (>95%) with shorter treatment durations and reduced side effects.

Therapeutic Advantages of DAKLINZA
Daclatasvir exerts its antiviral effect by inhibiting the NS5A replication complex, demonstrating high potency across diverse HCV genotypes, notably genotypes 1, 3, and 4 [2]. Its flexible combination use with other DAAs, such as sofosbuvir and ribavirin, enhances treatment efficacy, making it attractive for both treatment-naïve and treatment-experienced patients.

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Regulatory and Geographic Expansion

Regulatory Approvals and Indications
DACLINZA received FDA approval in 2015 for use in combination with other agents to treat chronic HCV infection. It is approved in multiple markets, including Europe, Japan, and emerging economies. Recent regulatory milestones include expanded indications for complex cases, such as patients with advanced liver disease, prompting broader adoption.

Geographic Penetration and Market Access
While initial adoption was concentrated in developed markets, recent efforts by Bristol-Myers Squibb and regional health authorities have expanded access in Asia, Latin America, and Africa. Price negotiations, alongside the availability of generic formulations in some territories, influence sales volumes and revenue flows.

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Market Competition and Dynamics

Competitive Landscape
DAKLINZA competes against a class of potent DAAs, such as Harvoni (ledipasvir-sofosbuvir), Epclusa (sofosbuvir-velpatasvir), and Zepatier (elbasvir-grazoprevir). The competitive advantage of DAKLINZA hinges on its pan-genotypic activity, shorter treatment durations, and favorable side-effect profile.

Market Share Trends
Though initially capturing a sizeable share in certain segments, DAKLINZA's dominance has faced gradual erosion due to emerging generics and newer fixed-dose combinations with simplified dosing regimens. Nonetheless, in specific markets, particularly where price barriers exist, DAKLINZA maintains a foothold due to proven efficacy and safety.

Pricing and Reimbursement Dynamics
Pricing strategies significantly impact DAKLINZA's financial trajectory. Bristol-Myers Squibb has adopted tiered pricing models, negotiated discounts, and collaborated with healthcare providers to mitigate cost barriers. Reimbursement approvals are critical, with country-specific formularies influencing sales.

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Financial Performance and Trajectory

Revenue Generation and Trends
Between 2015 and 2022, DAKLINZA generated peak revenues of over $650 million globally (notably in 2016-2017) [3]. Post-2018, revenues experienced a decline driven by market saturation and transition to newer therapies, compounded by generic competition in certain regions.

Revenue Drivers
The financial trajectory is predominantly influenced by:

• Market Penetration: Expansion in emerging markets enhances revenue streams.
• Treatment Guidelines Evolution: Inclusion in national protocols boosts sales.
• Pricing and Access: Negotiation strategies directly affect revenue levels.
• Patent Expiry and Generics: As patents expire, revenue declines unless offset by volume increases or new indications.

Forecasts and Future Outlook
Analysts project a continued revenue decline in mature markets owing to generic penetration but anticipate stable or modest growth in underserved regions. The drug’s grandfathered status and combination with other high-efficacy agents in development pipelines may influence future revenue streams positively.

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Market Challenges and Opportunities

Challenges

• Price Competition: Increasing availability of generics reduces profitability.
• Generic Substitutions: Hastening erosion of market share.
• Treatment Landscape Evolution: Emergence of pan-genotypic, ribavirin-free regimens complicates positioning.

Opportunities

• Combination Therapies: Developing fixed-dose combinations leveraging DACLINZA’s NS5A inhibition can rejuvenate sales.
• Expanding to Special Populations: Targeting pediatric or coinfected populations presents growth avenues.
• Innovative Pricing Models: Value-based pricing and expanded reimbursement can drive access and revenue.

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Regulatory and Patent Landscape

Patent Status and Intellectual Property
The original patent for DACLINZA was granted in multiple jurisdictions but is nearing expiry in several markets, risking increased generic competition. Bristol-Myers Squibb is pursuing secondary patents and formulation patents to extend exclusivity.

Regulatory Evolution
Adaptive regulatory pathways, including approvals for combination regimens, facilitate market retention. Nonetheless, regulatory agencies increasingly favor generics, intensifying the competition.

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Conclusion

DACLINZA has established a significant position within the HCV treatment paradigm, with early high sales volumes driven by its potent antiviral activity and broad genotypic coverage. However, its financial trajectory now faces headwinds from patent expiration, generics, and evolving therapeutic options. The drug's future profitability hinges on strategic expansion into underserved markets, development of new combination therapies, and innovative pricing strategies. While the peak revenue phase has likely passed, DAKLINZA remains a valuable component of Bristol-Myers Squibb's antiviral portfolio, with scope for sustained, albeit gradually declining, revenues.

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Key Takeaways

• DACLINZA significantly impacted HCV treatment, with peak revenues over $650 million pre-2018.
• Patent expiration and generic competition are primary factors influencing the drug’s declining revenue trajectory.
• Market expansion in Asia, Africa, and Latin America offers growth potential despite challenges.
• Strategic development of fixed-dose combinations and expanding indications may revitalize sales.
• Ongoing negotiations and innovative access models are critical for maintaining market relevance.

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FAQs

Q1: What are the primary indications for DACLINZA?
A1: DACLINZA is indicated for the treatment of chronic hepatitis C virus infection, often used in combination with other antivirals such as sofosbuvir, especially for genotypes 1, 3, and 4.

Q2: How has patent expiry affected DAKLINZA's market presence?
A2: Patent expiration has accelerated generic entry in several regions, leading to reduced sales revenues and increased price competition.

Q3: What distinguishes DACLINZA from its competitors?
A3: Its broad genotypic activity, high efficacy, short treatment regimens, and favorable safety profile distinguish DACLINZA—though newer fixed-dose regimens are closing the gap.

Q4: Which regions are crucial for DAKLINZA’s future growth?
A4: Emerging markets in Asia, Latin America, and Africa are priorities due to less competition from generics and increasing access initiatives.

Q5: What strategies can Bristol-Myers Squibb employ to prolong DACLINZA’s market viability?
A5: Developing new combination therapies, expanding indications, strategic pricing, and forming partnerships for broader access are key strategies.

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References

[1] World Health Organization. ‘Global Hepatitis Report 2017.’
[2] European Medicines Agency. ‘Summary of Product Characteristics for Daklinza.’
[3] Bristol-Myers Squibb Annual Reports, 2015-2022.