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Last Updated: July 14, 2025

DAKLINZA Drug Patent Profile


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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

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Summary for DAKLINZA
Drug patent expirations by year for DAKLINZA
Drug Prices for DAKLINZA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DAKLINZA
Generic Entry Date for DAKLINZA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Ain Shams UniversityPhase 3
Cairo UniversityPhase 3
Tanta UniversityPhase 2/Phase 3

See all DAKLINZA clinical trials

US Patents and Regulatory Information for DAKLINZA

DAKLINZA is protected by eight US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DAKLINZA is ⤷  Try for Free.

This potential generic entry date is based on patent ⤷  Try for Free.

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 ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 0016
Patent: 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
Estimated Expiration: ⤷  Try for Free

Patent: 4566
Patent: FORMA CRISTALINA DE LA SAL DICLORHIDRATO DE ((1S)-1-(((2S)-2-(5-(4-(2-((2S)-1-((2S)-2-((METOXICARBONIL)AMINO)-3-METILBUTANOIL)-2-PIRROLIDINIL)-1H-IMIDAZOL-5-IL)-4-BIFENILIL)-1H-IMIDAZOL-2-IL)-1-PIRROLIDINIL)CARBONIL)-2-METILPROPIL)CARBAMATO DE METILO
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 08284100
Patent: 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
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 0815142
Patent: FORMA CRISTALINA DO SAL DE DICLORIDRATO ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((METOXICARBONIL)-3-MET ILBUTANOIL)-2-PIRROLIDINIL)-1H-IMIDAZOL-5-IL)-4-BIFENILIL)- 1H-IMIDAZOL-2-IL)-1-PIRROLIDINIL)CARBONIL)-2-METELPROPI L)CARBAMATO DE METILA
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 95729
Patent: FORME CRISTALLINE DE DIHYDROCHLORURE DE 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 (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)
Estimated Expiration: ⤷  Try for Free

Chile

Patent: 08002354
Patent: Forma cristalina de la sal diclorhidrato de ((1s)-1-(((2s)-2-(5-(4'-(2-((2s)-1-((2s)-2-((metoxicarbonil)amino)-3-metilbutanoil)-2-pirrolidinil)-1h-imidazol-5-il)-4-bifenilil)-1h-imidazol-2-il)-1-pirrolidinil)carbonil)-2-metilpropil)carbamato de metilo; composición y combinacion farmacéutica; y su uso para tratar la hepatitis c.
Estimated Expiration: ⤷  Try for Free

China

Patent: 1778840
Patent: 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
Estimated Expiration: ⤷  Try for Free

Colombia

Patent: 60327
Patent: FORMA CRISTALINA DE LA SAL DICLORHIDRATO DE ((2S)-2-(5-(4`-(2((2S)-1-((2S)-2-((METOXICARBONIL)AMINO)-3-METILBUTANIOL)-2-PIRROLIDINIL)-1H-IMIDAZOL-5-IL-4BIFENILIL)-1H-IMIDAZOL-2-IL)-1-PIRROLIDINIL)CARBONIL)-2-METILPROPIL)CARBAMATO DE METILO
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

Patent: 8152
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА ДИГИДРОХЛОРИДА МЕТИЛ ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((МЕТОКСИКАРБОНИЛ)АМИНО)-3-МЕТИЛБУТАНОИЛ)-2-ПИРРОЛИДИНИЛ)-1Н-ИМИДАЗОЛ-5-ИЛ)-4-БИФЕНИЛИЛ)-1Н-ИМИДАЗОЛ-2-ИЛ)-1-ПИРРОЛИДИНИЛ)КАРБОНИЛ)-2-МЕТИЛПРОПИЛ)КАРБАМАТА (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)
Estimated Expiration: ⤷  Try for Free

Patent: 1000196
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА ДИГИДРОХЛОРИДА МЕТИЛ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((МЕТОКСИКАРБОНИЛ)АМИНО)-3-МЕТИЛБУТАНОИЛ)-2-ПИРРОЛИДИНИЛ)-1Н-ИМИДАЗОЛ-5-ИЛ)-4-БИФЕНИЛИЛ)-1Н-ИМИДАЗОЛ-2-ИЛ)-1-ПИРРОЛИДИНИЛ)КАРБОНИЛ)-2-МЕТИЛПРОПИЛ)КАРБАМАТА
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 83244
Patent: FORME CRISTALLINE DE DIHYDROCHLORURE DE MÉTHYL ((1S)-1-(((2S>2-(5-(4'-(2-((2S)-1-((2S)-2-((MÉTHOXYCARBONYL)AMINO)-3-MÉTHYLBUTANOYL)-2-PYRROLIDINYL)-1H-IMIDAZOL-5-YL)-4-BIPHÉNYLYL)-1H-IMIDAZOL-2-YL)-1-PYRROLIDINYL)CARBONYL)-2-MÉTHYLPROPYL)CARBAMATE (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)
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 44089
Patent: 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
Estimated Expiration: ⤷  Try for Free

Israel

Patent: 3684
Patent: צורות גבישייות של מלחי מיטל ((s1) - 1 - (((s2) - 2 - (5 - ('4 (2 - ((s2) - 1 - ((s2) - 2 - ((מטוקסיקרבוניל) אמינו) - 3 - מטילביוטאנויל) - 2 - פירולידיניל) - h1 - אמידאזול - 5 - איל) - 4 - ביפניליל) - h1 - אימידאזול - 2 - איל) - 1 - פירולידיניל) קרבוניל)-2-מטילפרופיל) קרבמט דיהידרוכלור (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)
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 44179
Estimated Expiration: ⤷  Try for Free

Patent: 10535785
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 10001368
Patent: FORMA CRISTALINA DE LA SAL DICLORHIDRATO DE ((1S)-1-(((2S)-2-(5-(4 ́-(2-((2S)-1-((2S)-2-((METOXICARBONIL) AMINO)-3-METILBUTANOIL)-2-P IRROLIDINIL)-1H-IMIDAZOL-5-IL)-4-BIFENILIL)-1H-IMIDAZOL-2-IL)-1-P IRROLIDINIL) CARBONIL)-2-METILPROPIL)CARBAMATO DE (CRYSTALLINE FORM OF METHYL ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2 S)-2-((METHOXYCARBONYL)AMINO)-3-METHYLBUTANOYL)-2-PYRROLIDINYL)- 1H-IMIDAZOL-5-YL)-4-BIPHENYLYL)-1H-IMIDAZOL-2-YL)-1-PYRROLIDINYL )CARBONYL)-2-METHYLPROPYL)CARBAMATE DIHYDROCHLORIDE SA)
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 3148
Patent: 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
Estimated Expiration: ⤷  Try for Free

Peru

Patent: 090940
Patent: FORMA CRISTALINA DE LA SAL DICLORHIDRATO DE ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((METOXICARBONIL)AMINO)-3-METILBUTANOIL)-2-PIRROLIDINIL)-1H-IMIDAZOL-5-IL)-4-BIFENILIL)-1H-IMIDAZOL-2-IL)-1-PIRROLIDINIL)CARBONIL)-2-METILPROPIL)CARBAMATO DE METIL
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 1000843
Patent: 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
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 1508022
Estimated Expiration: ⤷  Try for Free

Patent: 100042641
Patent: 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
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 02791
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 59813
Estimated Expiration: ⤷  Try for Free

Patent: 0911790
Patent: 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
Estimated Expiration: ⤷  Try for Free

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 ⤷  Try for Free
Slovenia 2049522 ⤷  Try for Free
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 ⤷  Try for Free
Spain 2662590 ⤷  Try for Free
Israel 196813 תרכובות ביפניל ביסאימידאזול, תכשירים המכילים אותן ושימושים בהן (Biphenyl bisimidazole compounds, compositions comprising the same and uses thereof) ⤷  Try for Free
South Korea 20140066768 HEPATITIS C VIRUS INHIBITORS ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DAKLINZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049522 211 50001-2015 Slovakia ⤷  Try for Free PRODUCT NAME: DAKLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939 - EU/1/14/939/004 20140826
2049522 C20150003 00128 Estonia ⤷  Try for Free PRODUCT NAME: DAKLATASVIIR;REG NO/DATE: EU/1/14/939 26.08.2014
2049522 CA 2015 00003 Denmark ⤷  Try for Free PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140822
2049522 PA2015006,C2049522 Lithuania ⤷  Try for Free 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 ⤷  Try for Free PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 20140826
2049522 300713 Netherlands ⤷  Try for Free DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.

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