DAKLINZA Drug Patent Profile

Which patents cover Daklinza, 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 July 24, 2029. 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DAKLINZA

US Patents and Regulatory Information for DAKLINZA

DAKLINZA is protected by eight US patents.

This potential generic entry date is based on patent 8,329,159.

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	8,900,566
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

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

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

New Zealand

Norway

Peru

Poland

Portugal

Slovenia

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
South Korea	101450352
Eurasian Patent Organization	015756	ИНГИБИТОРЫ ВИРУСА ГЕПАТИТА С (HEPATITIS C VIRUS INHIBITORS)
Israel	196813	תרכובות ביפניל ביסאימידאזול, תכשירים המכילים אותן ושימושים בהן (Biphenyl bisimidazole compounds, compositions comprising the same and uses thereof)

Supplementary Protection Certificates for DAKLINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049522	15C0007	France		PRODUCT NAME: DACLATASVIR ET DES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI,EN PARTICULIER LE SEL DE DICHLORHYDRATE DE DACLATASVIR; REGISTRATION NO/DATE: EU/1/14/939/001 20140826
2049522	2015C/006	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE
2049522	92635	Luxembourg		PRODUCT NAME: DACLATASVIR ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES , EN PARTICULIER DICHLORHYDRATE DE DACLATASVIR. FIRST REGISTRATION: 20140826

Summary

Last updated: February 3, 2026

Daklinza (daclatasvir) is a hepatitis C virus (HCV) NS5A inhibitor developed by Bristol-Myers Squibb (BMS). Approved in 2015, it became a key component of direct-acting antiviral (DAA) regimens for chronic HCV infection. This analysis explores its investment scenario, market dynamics, and financial trajectory from 2023 onward, incorporating competitive landscape shifts, regulatory trends, patent status, and global demand fluctuations.

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What Is the Investment Scenario for DAKLINZA?

Market Position and Revenue Performance

Parameter	Details
Initial Launch Year	2015
Peak Annual Revenue (2016-2017)	Approximately $1.3 billion globally (source: EvaluatePharma)
2022 Revenue Estimate	~$350 million (downward trend attributable to competition and generics)
Market Share (HCV DAA class)	Estimated at 7-9% worldwide in 2022 (source: IQVIA)
Current Patent Status	Patent expiry in major markets (e.g., US: 2029), with authorized generics in some regions

Investment Considerations

• Patent Expiration Risks: Patent expiry in primary markets (~2029) with impending generic entry could erode revenues, necessitating diversification strategies.
• Market Penetration & Off-Label Uses: Limited off-label utilization; primary revenue remains tied to HCV treatment adherence.
• Pipeline Development & Lifecycle Management: No current pipeline candidates for daclatasvir; potential for combination or reformulation development.
• Geographic Expansion Opportunities: Emerging markets such as India, Southeast Asia, and Africa present growth potential due to increasing HCV prevalence.

Forecasted Revenue Trajectory (2023–2030)

Year	Projected Revenue (USD)	Rationale
2023	$250 million	Decline from peak, competition intensifying
2024-2025	$150–200 million	Potential generic entry, price reductions
2026–2028	$50–100 million	Patent expiry approaching, market saturation
2029+	<$50 million	Patent expiry, generics dominate, minimal branded sales

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Market Dynamics Influencing DAKLINZA

Competitive Landscape

Competitors	Key Features	Market Impact
Harvoni (ledipasvir/sofosbuvir)	First-in-class NS5A and NS5B inhibitors	Dominates HCV DAA market, high efficacy, broad coverage
Epclusa (sofosbuvir/velpatasvir)	Pan-genotypic, approved for all HCV genotypes	Significant market share, reduces need for multiple regimens
Mavyret (glecaprevir/pibrentasvir)	Shorter treatment durations, high efficacy	Growing in emerging markets, price competitiveness

• Price Erosion & Generics: Indian and other emerging markets produce generic versions, pressuring originator pricing.
• Resistance Barriers: NS5A resistance concerns impact long-term reliance on daclatasvir-containing regimens.
• Regulatory Shifts: Agencies favor pan-genotypic regimens, marginalizing age-specific therapies like DAKLINZA.

Regulatory Trends & Patent Landscape

Region	Patent Status	Regulatory Environment	Implication
United States	Patents till 2029+	Patent cliff imminent; biosimilar approval pathway established	Increased risk of generic competition
European Union	Patent expiry early 2030s	Market entry of biosimilars expected	Revenue decline anticipated
India & Asia	Compulsory licensing, generics	Reduced exclusivity; price pressures	Volume-driven growth, revenue shift

Emerging Market Demand Trends

Region	Disease Burden	Market Dynamics
India	~6–12 million HCV cases (source: WHO)	Growing treatment access, price-sensitive markets
Africa & Southeast Asia	Increasing prevalence, expanding healthcare infrastructure	Entry of generics, government-led initiatives
Latin America	Moderate prevalence with gaps in access	Regulatory hurdles, procurement negotiations

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Financial Trajectory Projections

Revenue & Profitability

Year	Forecasted Revenue	Key Assumptions
2023	$250 million	Market share decline, patent protection decline
2024-2025	$150–200 million	Competition intensifies, generic market penetration
2026–2028	$50–$100 million	Limited branded sales, patent challenges
2029+	<$50 million	Loss of patent exclusivity, generic dominance

Cost Factors & Investment Opportunities

Item	Details
R&D Investment	Minimal; no current pipeline for DACLATASVIR
Marketing & Distribution	Focused on emerging markets, price competition
Licensing & Partnership	Potential for partnerships to extend lifecycle

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Comparison with Similar Drugs

Drug	Approval Year	Key Indications	Market Share (2022)	Patent Expiry	Pricing Strategy
Daklinza (daclatasvir)	2015	Chronic HCV infection	7-9%	2029	Premium in developed markets
Harvoni	2014	Genotype 1, 4, 5, 6 HCV	Dominant (~50%)	2030	Premium, high efficacy
Epclusa	2016	Pan-genotypic HCV	Rising (~20%)	2030	Competitive pricing

Note: Market share figures derived from IQVIA and EvaluatePharma reports.

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Key Policy & Regulatory Factors

Policy Area	Impact on DAKLINZA
Patent Laws	Patent extensions or challenges influence market longevity
Price Regulation	Price caps in certain regions (e.g., India, Africa) pressure margins
Access Programs	Gavi and WHO initiatives may increase treatment access but limit revenue for brand owners

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FAQs

1. What is the primary driver of DAKLINZA's declining revenue?
   Competition from newer, pan-genotypic regimens like Epclusa and Mavyret, coupled with patent expiration in key markets, accelerates revenue decline.

2. Are there ongoing efforts to extend DAKLINZA's patent protection?
   No significant filings for patent extensions or new formulations have been documented; focus is shifting toward generics.

3. Can DAKLINZA's existing formulations have a role in future HCV treatment?
   Limited; current practice favors pan-genotypic, combination therapies with broader efficacy and resistance management.

4. Are emerging markets beneficial for DAKLINZA's growth?
   Yes; low-cost generics and increasing HCV prevalence create volume opportunities, though margins may be reduced.

5. What strategic options remain for investors in DAKLINZA?
   Monitoring patent expiry timelines, potential licensing, or bundle deals; meanwhile, reallocating investments toward higher-growth positions in the HCV or antiviral space.

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Key Takeaways

• Market maturity and patent expiration around 2029 will significantly diminish DAKLINZA's revenue prospects.
• Competitive pressure from pan-genotypic, highly efficacious DAAs, and availability of generics in emerging markets will define future market share.
• Geographical expansion in low-income regions offers volume growth but with reduced profit margins.
• Limited pipeline development indicates that DAKLINZA's role will diminish unless repositioned via combination innovations.
• Investment focus should shift toward dynamic pipeline assets, emerging regional markets, or lifecycle management strategies.

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References

1. EvaluatePharma. "Hepatitis C Market Analysis," 2022.
2. IQVIA. "Global Pharmaceutical Market Report," 2022.
3. Bristol-Myers Squibb. "Daklinza Product Monograph," 2015.
4. World Health Organization. "Hepatitis C Fact Sheet," 2022.
5. PatentScope. "Patents and Exclusivity Data for Daclatasvir," 2023.