DAKLINZA Drug Patent Profile

✉ Email this page to a colleague

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

< Available with Subscription >

Subscribe

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for DAKLINZA?
What are the global sales for DAKLINZA?
What is Average Wholesale Price for DAKLINZA?

Summary for DAKLINZA

International Patents:	93
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	13
Patent Applications:	13
Drug Prices:	Drug price information for DAKLINZA
DailyMed Link:	DAKLINZA at DailyMed

Drug patent expirations by year for DAKLINZA

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

Generic Entry Date for DAKLINZA^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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.

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

This potential generic entry date is based on patent ⤷ Subscribe.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Subscribe
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	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-001	Jul 24, 2015		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe		Y		⤷ Subscribe
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe		Y		⤷ Subscribe
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-001	Jul 24, 2015		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe		Y		⤷ Subscribe
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe		Y		⤷ Subscribe
>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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

Japan

Patent: 44179
Estimated Expiration: ⤷ Subscribe

Patent: 10535785
Estimated Expiration: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

South Korea

Patent: 1508022
Estimated Expiration: ⤷ Subscribe

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: ⤷ Subscribe

Spain

Patent: 02791
Estimated Expiration: ⤷ Subscribe

Taiwan

Patent: 59813
Estimated Expiration: ⤷ Subscribe

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: ⤷ Subscribe

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.

Subscribe to access the full database, or Subscribe
Country	Patent Number	Title	Estimated Expiration
Colombia	6160327	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	⤷ Subscribe
Hungary	E029145		⤷ Subscribe
European Patent Office	3042901	INHIBITEURS DU VIRUS DE L'HEPATITE C (HEPATITIS C VIRUS INHIBITORS)	⤷ Subscribe
European Patent Office	2784075	Inhibiteurs du virus de l'hépatite C (Hepatitis C virus inhibitors)	⤷ Subscribe
Croatia	P20160410		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DAKLINZA

Subscribe to access the full database, or Subscribe
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049522	PA2015006,C2049522	Lithuania	⤷ Subscribe	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	9/2015	Austria	⤷ Subscribe	PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826
2049522	211 50001-2015	Slovakia	⤷ Subscribe	PRODUCT NAME: DAKLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939 - EU/1/14/939/004 20140826
2049522	92635	Luxembourg	⤷ Subscribe	PRODUCT NAME: DACLATASVIR ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES , EN PARTICULIER DICHLORHYDRATE DE DACLATASVIR. FIRST REGISTRATION: 20140826
2049522	C02049522/01	Switzerland	⤷ Subscribe	ADRESSAENDERUNG
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

DAKLINZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Daklinza

Introduction to Daklinza

Daklinza, also known as daclatasvir, is a direct-acting antiviral (DAA) drug developed by Bristol-Myers Squibb (BMS) for the treatment of chronic hepatitis C virus (HCV) infection. Here, we will delve into the market dynamics and financial trajectory of Daklinza, highlighting its challenges, successes, and future prospects.

Market Entry and Initial Reception

Daklinza was first approved in the European Union in 2014 for use in combination with other medicinal products for the treatment of HCV. It also gained approval in Japan, where it is used in combination with Sunvepra (asunaprevir)[3].

Global Market Presence

Despite its approvals, Daklinza's market presence has been challenged by the dominance of Gilead Sciences' Sovaldi and Harvoni. The treatment guidelines from major medical societies such as AASLD and EASL often recommend Daklinza in combination with Sovaldi or Sovaldi and ribavirin, which has limited its standalone market share. As a result, BMS and other competitors like Janssen have struggled to gain significant market share against Gilead[1].

Competitive Landscape

The HCV treatment market is highly competitive, with multiple DAAs available. Daklinza faces competition from other DAAs such as Merck's Zepatier (grazoprevir/elbasvir) and Janssen's Olysio (simeprevir). The competitive landscape is further complicated by the pricing strategies of these drugs, with Gilead's products often being priced higher but still dominating the market due to their efficacy and physician recommendations[1].

Financial Performance

Bristol-Myers Squibb's financial reports indicate that while Daklinza has contributed to the company's revenues, it has not been a major driver compared to other products like Opdivo and Eliquis. In 2014, BMS reported revenues of $15.9 billion, with new and inline product sales growing by 19%, but Daklinza's specific contribution was not highlighted as a major factor in this growth[3].

Pricing and Revenue

The pricing of Daklinza has been a critical factor in its market performance. The wholesale acquisition cost (WAC) of Daklinza is lower compared to Gilead's Sovaldi and Harvoni, but it still faces significant price competition. For instance, the average revenue per treatment for Gilead's HCV drugs dropped by 22% in the first half of 2016 following the launch of Merck's Zepatier, which was priced at $54,000 per treatment. This pricing pressure has affected the revenue potential of Daklinza[1].

Regulatory Challenges

Daklinza faced regulatory hurdles in the US, particularly after BMS withdrew its New Drug Application for asunaprevir due to the rapidly changing HCV treatment landscape. The FDA requested additional information about Daklinza's use in combination with other agents, delaying its US approval. However, BMS has continued to work on addressing these regulatory requirements[3].

Pharmacoeconomic Analysis

Pharmacoeconomic reviews, such as the one conducted by the Common Drug Review in Canada, have analyzed the cost-effectiveness of Daklinza. The analysis indicated that Daklinza in combination with Sovaldi (DCV + SOF) is cost-effective in certain patient groups, particularly non-cirrhotic patients, but not for those with cirrhosis who require longer treatment durations[4].

Future Prospects

The future prospects for Daklinza are tied to several factors, including the simplification of treatment algorithms, improved efficacy outcomes for difficult-to-treat patients, and enhancements in safety and tolerability. Clinical trials are ongoing to assess the efficacy of DAAs, including Daklinza, in patients with severe comorbidities such as kidney and renal failure. Additionally, the elimination of ribavirin for patients with decompensated liver cirrhosis could be a significant advantage for newly launching DAAs[1].

Global Outlook and Market Dynamics

The global HCV treatment market is expected to see further diversification and intensification with the launch of new pan-genotypic drugs. However, price erosion is unlikely to continue at the same pace due to the high treatment rates and low incidence rates in many countries. The disease prevalence itself is a key factor in maintaining price stability, as the patient population seeking treatment is decreasing[1].

Key Takeaways

Market Competition: Daklinza faces significant competition from Gilead's Sovaldi and Harvoni, as well as other DAAs.
Pricing Strategies: The drug's pricing is critical, with ongoing price competition affecting revenue.
Regulatory Challenges: Daklinza has faced delays in US approval due to regulatory requirements.
Pharmacoeconomic Analysis: The drug is cost-effective in certain patient groups but not in others.
Future Prospects: Simplification of treatment algorithms and improvements in efficacy and safety are key to future success.

FAQs

Q: What is Daklinza used for? A: Daklinza (daclatasvir) is used for the treatment of chronic hepatitis C virus (HCV) infection.

Q: Who developed Daklinza? A: Daklinza was developed by Bristol-Myers Squibb (BMS).

Q: What are the main challenges faced by Daklinza in the market? A: Daklinza faces significant competition from other DAAs, particularly Gilead's Sovaldi and Harvoni, and has faced regulatory delays in the US.

Q: How does the pricing of Daklinza compare to other HCV treatments? A: Daklinza's pricing is generally lower than Gilead's Sovaldi and Harvoni, but it still faces price competition from other DAAs.

Q: What are the future prospects for Daklinza? A: The future prospects for Daklinza depend on simplifying treatment algorithms, improving efficacy and safety, and addressing the needs of difficult-to-treat patient groups.

Sources

Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies - Drug Development
Bristol-Myers Squibb Reports Fourth Quarter and Full Year Financial Results for 2019 - Bristol-Myers Squibb
Delivering Transformational Medicines to Patients - Bristol-Myers Squibb 2014 Annual Report
CDR Pharmacoeconomic Review Report for Daklinza - Common Drug Review

More… ↓

⤷ Subscribe