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:	13
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	206843-001	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
Brazil	PI0815142	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
South Africa	200900962	HEPATITIS C VIRUS INHIBITORS
South Korea	20090040909	HEPATITIS C VIRUS INHIBITORS
Spain	2402791

Supplementary Protection Certificates for DAKLINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049522	2015C/006	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE
2049522	524	Finland
2049522	9/2015	Austria		PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826
2049522	SPC/GB15/003	United Kingdom		PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REGISTERED: UK EU/1/14/939/001-004 20140826

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

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