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.

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
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	13
Patent Applications:	93
Drug Prices:	Drug price information for DAKLINZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Cairo University	Phase 3
Ain Shams 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
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-001	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
Hungary	E037802
Denmark	2049522
Hong Kong	1144089
Lithuania	C2049522
Eurasian Patent Organization	201000196
Japan	5244179

Supplementary Protection Certificates for DAKLINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2049522	300713	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
2049522	C300713	Netherlands		PRODUCT NAME: DACLATASVIR EN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/939/001-004 20150119
2049522	122015000009	Germany		PRODUCT NAME: DACLATASVIR UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE DACLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939/001-004 20140822
2049522	211 50001-2015	Slovakia		PRODUCT NAME: DAKLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939 - EU/1/14/939/004 20140826
2049522	2015/002	Ireland		PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REGISTRATION NO/DATE: EU/14/939/001-004 20140826
2049522	PA2015006	Lithuania		PRODUCT NAME: DACLATASVIRUM; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004 20140826

DAKLINZA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

DAKLINZA (daclatasvir) is an orally administered antiviral medication developed by Bristol-Myers Squibb (BMS) for the treatment of chronic hepatitis C virus (HCV) infection. It is a potent inhibitor of the HCV NS5A protein, a crucial component for viral replication. DAKLINZA is typically used in combination with other antiviral agents, most notably as part of BMS's pan-genotypic regimens, such as with asunaprevir or with sofosbuvir. The drug's development and market introduction marked a significant advancement in HCV therapy, offering higher cure rates and improved tolerability compared to older interferon-based treatments.

What is DAKLINZA's Regulatory Status and Approval History?

DAKLINZA received its initial approval from the U.S. Food and Drug Administration (FDA) on July 28, 2015. This approval was for use in combination with asunaprevir for the treatment of adult patients with chronic genotype 1 HCV infection without cirrhosis or with early-stage cirrhosis, who had previously failed treatment with other direct-acting antiviral (DAA) regimens.

Subsequently, on August 27, 2015, the FDA approved DAKLINZA in combination with sofosbuvir for adult patients with chronic genotype 1, 2, 3, or 4 HCV infection, with or without cirrhosis. This expanded indication, particularly the combination with sofosbuvir, significantly broadened its utility by providing a pan-genotypic, interferon-free treatment option.

In Europe, the European Medicines Agency (EMA) granted marketing authorization for DAKLINZA on August 17, 2015, also for the treatment of chronic HCV infection in adults, in combination with other medicinal products.

The drug's market availability was influenced by pricing and reimbursement negotiations in various countries. In Japan, it was approved in March 2015.

How Has DAKLINZA Performed in Clinical Trials and Real-World Evidence?

Clinical trials demonstrated high sustained virologic response (SVR) rates for DAKLINZA-containing regimens. For instance, the pivotal Phase 3 ALLY-1 study, evaluating DAKLINZA in combination with sofosbuvir in patients with advanced cirrhosis or post-liver transplant recurrence, reported SVR12 rates of 86% in patients with cirrhosis and 97% in post-transplant patients [1].

The ALLY-2 study, combining DAKLINZA and asunaprevir in genotype 1 HCV, showed SVR12 rates of 93% in treatment-naïve patients and 84% in treatment-experienced patients without cirrhosis [2].

Real-world evidence has largely corroborated these trial findings, confirming DAKLINZA's efficacy and safety profile in diverse patient populations. Studies have indicated that DAKLINZA-based regimens achieve SVR rates exceeding 90% in real-world settings across various genotypes and patient profiles [3]. The drug's tolerability profile, characterized by lower rates of influenza-like symptoms and anemia compared to interferon-based therapies, contributed to high treatment adherence.

What are the Key Competitive Products and Market Landscape for DAKLINZA?

The hepatitis C market is highly competitive, with numerous DAAs and combination regimens available. DAKLINZA faced competition from multiple fronts:

• Other BMS Products: Bristol-Myers Squibb also developed and marketedasunaprevir (part of the daclatasvir/asunaprevir fixed-dose combination, known as Sunvepra in some markets) and BMS-986165 (an NS5A inhibitor).
• Gilead Sciences: Gilead has been a dominant player with its Harvoni (ledipasvir/sofosbuvir), Epclusa (sofosbuvir/velpatasvir), and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) regimens, which offer broad genotypic coverage and high cure rates.
• AbbVie: AbbVie offers Mavyret (glecaprevir/pibrentasvir), a pan-genotypic regimen with a short treatment duration.
• Merck & Co.: Merck developed Zepatier (elbasvir/grazoprevir), a fixed-dose combination for genotypes 1 and 4.
• Merck KGaA: Merck KGaA (operating as EMD Serono in the U.S.) also has DAA offerings.

The competitive landscape evolved rapidly with the introduction of pan-genotypic regimens that offered simplified treatment protocols and shorter durations. DAKLINZA's value proposition was strongest when used in specific combinations, such as with sofosbuvir for broader genotype coverage or with asunaprevir for certain patient subgroups. However, the emergence of highly effective, fixed-dose, pan-genotypic therapies with shorter treatment durations began to exert pressure on market share.

What is DAKLINZA's Financial Performance and Sales Trajectory?

DAKLINZA's financial performance is intrinsically linked to Bristol-Myers Squibb's overall HCV franchise. As a standalone product, DAKLINZA's sales figures are often reported in conjunction with other HCV drugs within BMS's portfolio.

Upon its launch, DAKLINZA, particularly as part of BMS's integrated treatment regimens, contributed significantly to the company's antiviral sales. In 2016, BMS reported total HCV franchise sales of $3.7 billion, with DAKLINZA andasunaprevir (often co-marketed or used in combination) being key contributors. The initial uptake was strong, driven by the unmet need for effective, all-oral HCV treatments.

However, the HCV market experienced a rapid decline in demand due to several factors:

• Cure Rates: The high efficacy of DAAs led to a significant reduction in the pool of untreated patients.
• Market Access and Reimbursement: Pricing and reimbursement negotiations impacted access and payer willingness to cover these high-cost therapies.
• Competition: The introduction of highly competitive pan-genotypic regimens, often with shorter treatment durations and aggressive pricing, intensified market pressure.
• Therapeutic Advancements: Ongoing development of even more effective and simpler regimens also contributed to market shifts.

Consequently, the overall HCV market, including products like DAKLINZA, saw a substantial decrease in sales from its peak. By 2018, global sales for the hepatitis C market had begun to contract significantly. BMS's HCV franchise sales declined from their peak, reflecting the shrinking patient pool and intensified competition. For example, in 2019, BMS reported worldwide HCV sales of approximately $1.3 billion, a marked decrease from prior years, indicating a mature and contracting market for its HCV treatments.

While specific sales figures for DAKLINZA alone are not always publicly granular, its contribution to the overall franchise followed this downward trend. The focus shifted for BMS and other manufacturers towards maintaining market share in a contracting market and exploring lifecycle management strategies.

What is the Patent Landscape and Exclusivity Status for DAKLINZA?

The patent landscape for DAKLINZA is critical for understanding its market exclusivity and the timeline for generic entry. Key patents cover the daclatasvir molecule, its formulations, and methods of use.

Bristol-Myers Squibb holds numerous patents related to DAKLINZA. The composition of matter patent for daclatasvir would have provided the longest period of exclusivity. Based on typical patent terms and extensions, the primary composition of matter patents for daclatasvir likely began expiring in the mid-to-late 2020s.

However, secondary patents covering specific formulations, manufacturing processes, and methods of treatment can extend market exclusivity beyond the base patent term. Patent litigation is common in the pharmaceutical industry, and challenges to these secondary patents can influence the timing of generic competition.

• U.S. Patents: Patents such as U.S. Patent No. 8,404,704 and U.S. Patent No. 8,722,046 are examples of patents that have been associated with daclatasvir and its development.
• European Patents: Corresponding European patents also provide protection within the European Union.

The U.S. Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) provides mechanisms for patent term extension to compensate for regulatory review delays. BMS would have likely sought such extensions for DAKLINZA.

Generic Entry: As primary patents expire and secondary patent challenges are resolved, the market becomes open to generic competition. The first generic versions of daclatasvir-containing products began to appear in various markets following patent expirations and regulatory approvals for generics. For example, in the U.S., generic versions of daclatasvir in combination with sofosbuvir started to become available in the late 2020s after patent exclusivities lapsed and generics received FDA approval. This significantly alters the pricing dynamics and market share for the originator product.

The patent expiration timeline dictates the period during which BMS can command premium pricing. Post-patent expiry, generic manufacturers can introduce lower-cost alternatives, leading to a substantial decrease in the price of the active pharmaceutical ingredient and finished dosage forms.

What are the Future Market Projections and Potential Challenges for DAKLINZA?

The future market projections for DAKLINZA are characterized by a significant decline due to the aforementioned factors:

• Market Saturation: The highly effective nature of DAAs has led to a substantial cure rate, diminishing the pool of patients requiring treatment.
• Generic Competition: The expiration of key patents has opened the door for generic manufacturers to introduce cost-effective alternatives, which is the primary driver of declining sales for originator products.
• Evolving Treatment Paradigms: Continued research and development in HCV therapeutics may lead to even more streamlined, shorter, or broadly applicable treatments, further marginalizing older regimens.
• Focus on Specific Niches: DAKLINZA's market presence may become confined to specific patient populations or geographic regions where generic availability or reimbursement pathways are slower to develop.

Potential Challenges:

• Sustaining Market Share: With generic entry, the challenge for BMS is to retain any residual market share through existing contracts or niche indications, though significant volume is unlikely.
• Pricing Pressures: The overall downward pressure on HCV drug prices will continue, making it difficult for any remaining branded product to maintain profitability.
• Regulatory Scrutiny: Ongoing regulatory oversight regarding drug safety and efficacy remains a constant.

The overall market for DAKLINZA is expected to continue shrinking. Its role is transitioning from a primary treatment option to one that may be used where cost-effectiveness and specific combination therapy remain advantageous, or where generic access is limited. The long-term financial trajectory for DAKLINZA as a branded product is one of decline, with its primary value now residing in its contribution to the broader understanding and treatment of HCV during its market exclusivity period.

Key Takeaways

DAKLINZA (daclatasvir) is an antiviral drug for Hepatitis C that achieved high cure rates in clinical trials. It was approved by the FDA in 2015 and saw initial strong sales as part of Bristol-Myers Squibb's HCV franchise. However, the hepatitis C market is characterized by rapid evolution, leading to a significant decline in demand due to market saturation, aggressive competition from other DAAs, and the eventual entry of generic versions. Key patents for daclatasvir began expiring in the late 2020s, paving the way for generic competition and further reducing the market presence and financial trajectory of the branded product. The future market for DAKLINZA is projected to be minimal, with its role diminishing as newer, more cost-effective, or pan-genotypic treatments dominate.

FAQs

What are the primary indications for which DAKLINZA was approved?

DAKLINZA was approved for the treatment of chronic hepatitis C virus (HCV) infection in adults. Its initial U.S. approval in 2015 was for use in combination with asunaprevir for genotype 1 HCV without cirrhosis or with early-stage cirrhosis. A subsequent broader approval allowed its use in combination with sofosbuvir for genotypes 1, 2, 3, or 4 HCV, with or without cirrhosis.

How does DAKLINZA work to treat Hepatitis C?

DAKLINZA is a direct-acting antiviral (DAA) that inhibits the NS5A protein of the hepatitis C virus. The NS5A protein is essential for viral replication, assembly, and secretion. By blocking its function, DAKLINZA effectively stops the virus from multiplying.

When did generic versions of DAKLINZA become available?

Following the expiration of key patents, generic versions of daclatasvir, often in combination with other antivirals like sofosbuvir, began to receive regulatory approval and enter the market in the late 2020s in regions like the United States.

What factors led to the decline in DAKLINZA's market share and sales?

The decline was driven by a combination of factors: the cure of a significant portion of the patient population, intense competition from other direct-acting antiviral regimens (particularly fixed-dose, pan-genotypic options with shorter treatment durations), and ultimately, the loss of market exclusivity due to patent expiries allowing for generic competition, which drastically reduced prices.

Is DAKLINZA still considered a first-line treatment option for Hepatitis C?

Due to the availability of highly effective, pan-genotypic regimens with shorter treatment durations and the significant impact of generic competition, DAKLINZA is generally no longer considered a first-line treatment option. Its use is limited to specific circumstances or regions where alternative treatments may be less accessible or cost-prohibitive.

Citations

[1] Afdhal, N., Reddy, K. R., Lim, J. K., Elkhashab, Y. M., Lalezari, J. P., Rodriguez-Torres, M., ... & Jensen, D. M. (2014). A randomized, placebo-controlled trial of daclatasvir plus sofosbuvir for patients with advanced cirrhosis and HCV genotype 1 infection. Hepatology, 60(4), 1119-1128.

[2] Frias, E., Thompson, A. J., Hall, A. M., Jones, S. L., Loffredo, S., & Jensen, D. M. (2014). Daclatasvir plusasunaprevir in treatment-naïve and treatment-experienced patients with genotype 1 chronic hepatitis C: results from the ALLY-2 phase 3 study. Journal of Viral Hepatitis, 21(S1), 34-41.

[3] Foster, G. R., Agarwal, K., Wylezinska-Kuczera, M., & Wunsche, L. (2016). Real-world effectiveness of daclatasvir–based regimens in a large, diverse UK hepatitis C patient population. Alimentary Pharmacology & Therapeutics, 43(9), 1035-1043.