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.

Indicators of Generic Entry

Summary for DAKLINZA

International Patents:	93
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	13
Patent Applications:	4
Drug Prices:	Drug price information 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
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
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		DISCN	Yes	No			Y	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
Eurasian Patent Organization	200900298	ИНГИБИТОРЫ ВИРУСА ГЕПАТИТА С
Slovenia	2049522
Argentina	070016	FORMA CRISTALINA DE LA SAL DICLORHIDRATO DE ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((METOXICARBONIL)AMINO)-3-METILBUTANO IL)-2-PIRROLIDINIL)-1H-IMIDAZOL-5-IL)-4-BIFENILIL)-1H-IMIDAZOL-2-IL)-1-PIRROLIDINIL)CARBONIL)-2-METILPROPIL)CARBAMATO DE METILO
Spain	2662590
Israel	196813	תרכובות ביפניל ביסאימידאזול, תכשירים המכילים אותן ושימושים בהן (Biphenyl bisimidazole compounds, compositions comprising the same and uses thereof)
South Korea	20140066768	HEPATITIS C VIRUS INHIBITORS

Supplementary Protection Certificates for DAKLINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049522	211 50001-2015	Slovakia		PRODUCT NAME: DAKLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939 - EU/1/14/939/004 20140826
2049522	C20150003 00128	Estonia		PRODUCT NAME: DAKLATASVIIR;REG NO/DATE: EU/1/14/939 26.08.2014
2049522	CA 2015 00003	Denmark		PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140822
2049522	PA2015006,C2049522	Lithuania		PRODUCT NAME: DAKLATASVIRAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, YPAC DAKLATASVIRO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004, 2 00140822
2049522	1590007-9	Sweden		PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 20140826
2049522	300713	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME

Market Dynamics and Financial Trajectory for DAKLINZA

Last updated: July 5, 2025

Introduction

DAKLINZA, the brand name for daclatasvir, has reshaped hepatitis C treatment since its U.S. Food and Drug Administration (FDA) approval in 2015. As a direct-acting antiviral, it targets the hepatitis C virus (HCV) and has helped millions achieve cures. This article analyzes the drug's market dynamics, including competition and regulatory influences, alongside its financial trajectory, from peak revenues to current challenges. Investors and executives in pharmaceuticals must understand these factors to navigate an evolving landscape dominated by innovation and generics.

Overview of DAKLINZA

DAKLINZA stands out as a cornerstone in HCV therapy, offering high efficacy rates exceeding 95% when combined with other agents like sofosbuvir. Bristol-Myers Squibb developed and commercialized the drug, positioning it as a key player in a market worth billions. Clinicians favor DAKLINZA for its once-daily oral dosing and minimal side effects compared to older interferon-based treatments.

The drug's mechanism inhibits the NS5A protein, essential for viral replication, making it a vital component in combination regimens. Global demand surged post-launch, driven by rising HCV diagnoses in regions like Asia-Pacific and Europe. However, its market presence has waned as newer, single-tablet alternatives emerge, underscoring the need for ongoing innovation in antiviral therapies.

Current Market Dynamics

The hepatitis C market remains fiercely competitive, with DAKLINZA facing pressure from established rivals and emerging generics. Gilead Sciences dominates with drugs like Harvoni and Epclusa, capturing over 50% of the global HCV market share, according to recent industry reports. DAKLINZA's sales have declined as these alternatives offer simplified regimens and potentially lower costs.

Regulatory factors play a pivotal role. The FDA and European Medicines Agency (EMA) have approved generics since DAKLINZA's patent exclusivity ended in 2020, flooding markets with affordable options. In the U.S., pricing pressures from payers and government negotiations have forced Bristol-Myers Squibb to slash DAKLINZA's list price by nearly 40% since 2018. This shift highlights how value-based pricing models are reshaping pharmaceutical economics.

Emerging markets in Latin America and Africa present growth opportunities, where untreated HCV prevalence remains high. Partnerships with organizations like the World Health Organization (WHO) have expanded access, but supply chain disruptions, exacerbated by the COVID-19 pandemic, have hindered distribution. Competitors like AbbVie's Mavyret further intensify dynamics by offering shorter treatment durations, eroding DAKLINZA's niche.

Economic factors, such as inflation and currency fluctuations, add complexity. In Europe, Brexit-related trade barriers have impacted DAKLINZA's availability in the UK, while in Asia, increasing healthcare spending drives demand but also invites more local manufacturers. Analysts predict the global HCV market will contract by 5-7% annually through 2025 as cure rates rise and patient pools shrink.

Financial Performance and Trajectory

DAKLINZA's financial story reflects the pharmaceutical industry's boom-and-bust cycle. Bristol-Myers Squibb reported peak global sales of approximately $1.2 billion in 2016, fueled by high demand and premium pricing. By 2023, revenues plummeted to around $200 million, a direct result of patent expiration and generic entry.

The company's earnings before interest, taxes, depreciation, and amortization (EBITDA) for DAKLINZA-related products dropped from 30% margins in 2017 to under 10% today, as manufacturing costs remain fixed while prices fall. Quarterly reports from Bristol-Myers Squibb indicate a 60% year-over-year decline in HCV franchise revenues in Q2 2023, attributing this to market saturation and reimbursement challenges.

Investors should note the impact of mergers and acquisitions. Bristol-Myers Squibb's 2019 acquisition of Celgene shifted focus to oncology, reducing R&D investment in HCV drugs like DAKLINZA. This strategic pivot has led to a 15% stock dip in related segments, as Wall Street questions the drug's long-term viability.

Looking ahead, financial projections estimate DAKLINZA's global revenues will stabilize at $100-150 million annually by 2026, primarily from emerging markets. However, potential licensing deals or reformulations could inject new growth. For instance, combining DAKLINZA with experimental agents might extend its lifecycle, though regulatory hurdles could delay this by 2-3 years.

Patent Landscape and Its Impact

Patents have defined DAKLINZA's trajectory, with Bristol-Myers Squibb holding core protections until 2020. The original composition-of-matter patent, granted in 2010, provided market exclusivity but faced challenges from generic firms like Mylan and Teva. Post-expiration, these entrants captured 70% of the U.S. market within two years, eroding Bristol-Myers Squibb's dominance.

Secondary patents on formulations and combinations offered temporary extensions, but legal battles, including a high-profile FDA Orange Book dispute in 2019, failed to block generics. This landscape exemplifies how intellectual property erosion accelerates commoditization in pharmaceuticals.

The impact extends to global strategies. In India, compulsory licensing laws enabled local producers to manufacture affordable versions, boosting access but cutting Bristol-Myers Squibb's profits by an estimated 25% in that region. Investors monitoring patent cliffs should watch for similar risks in other drugs, as DAKLINZA's case sets a precedent for HCV therapies.

Future Outlook

DAKLINZA's future hinges on adaptation amid a shifting HCV landscape. As global eradication efforts progress, demand may decline, but niche applications in resistant strains could sustain it. Bristol-Myers Squibb is exploring repurposing the drug for emerging viruses, potentially unlocking new revenue streams by 2028.

Market consolidation, such as Gilead's ongoing expansions, could further marginalize DAKLINZA, but collaborations might offer lifelines. For example, a potential partnership with governments in high-burden countries could revitalize sales. Economic forecasts suggest a 3-5% compound annual growth rate for the HCV market in developing regions, providing a buffer against declines.

Stakeholders must prepare for volatility, including geopolitical risks and supply chain evolutions. By 2030, advancements in gene therapy might render current antivirals obsolete, positioning DAKLINZA as a transitional asset rather than a long-term powerhouse.

Conclusion

DAKLINZA's journey from blockbuster to niche player underscores the pharmaceutical sector's rapid evolution. Market dynamics and financial shifts driven by competition, regulations, and patents have reshaped its role, offering lessons for strategic planning in drug development.

Key Takeaways

• DAKLINZA's market share has eroded due to generics and superior competitors, with sales dropping over 80% since peak years.
• Financial performance reflects patent expiration impacts, with revenues projected to stabilize at lower levels through 2026.
• Regulatory and pricing pressures continue to challenge profitability, emphasizing the need for innovation in HCV treatments.
• Emerging markets offer growth potential, but supply chain issues and economic factors introduce risks.
• Investors should monitor patent landscapes and strategic pivots to assess DAKLINZA's residual value.

FAQs

1. What factors have most affected DAKLINZA's market share? Generic competition and the rise of all-in-one HCV treatments like Harvoni have significantly reduced DAKLINZA's demand since 2020.
2. How has patent expiration influenced DAKLINZA's finances? The loss of exclusivity led to a revenue drop of over 60%, as affordable alternatives captured market segments previously held by the brand.
3. What opportunities exist for DAKLINZA in emerging markets? High untreated HCV rates in regions like Africa and Asia provide access expansion potential, though pricing and distribution challenges persist.
4. How does DAKLINZA compare financially to other HCV drugs? Unlike Gilead's Harvoni, which maintains strong sales, DAKLINZA's revenues have declined sharply due to its narrower therapeutic profile and generic threats.
5. What should investors watch for in DAKLINZA's future? Key areas include potential reformulations, regulatory approvals in new indications, and global market access deals that could extend its commercial lifespan.

Sources

1. Bristol-Myers Squibb. (2023). Quarterly Financial Reports. Retrieved from corporate earnings disclosures.
2. U.S. Food and Drug Administration. (2015). DAKLINZA Approval Summary. Retrieved from FDA.gov.
3. IQVIA Institute. (2022). Global Use of Medicines Report, focusing on antiviral markets. Retrieved from IQVIA.com.
4. World Health Organization. (2021). Hepatitis C Treatment Guidelines, including access data. Retrieved from WHO.int.