DAKLINZA Drug Patent Profile

Which patents cover Daklinza, 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 July 24, 2029. 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DAKLINZA

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

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

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

New Zealand

Norway

Peru

Poland

Portugal

Slovenia

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
Argentina	063684	DERIVADOS DE 4, 4´-BIFENILDIILBIS(1H-IMIDAZOL-5, 2-DIIL) COMO INHIBIDORES DEL VIRUS DE LA HEPATITIS C, COMPOSICION QUE LOS COMPRENDE Y SU USO PARA TRATAR UNA INFECCION CON VHC.
Argentina	108411	INHIBIDORES DEL VIRUS DE LA HEPATITIS C
Australia	2007286222	Hepatitis C virus inhibitors
Brazil	PI0716483	inibidores do vírus da hepatite c
Canada	2660520	INHIBITEURS DU VIRUS DE L'HEPATITE C (HEPATITIS C VIRUS INHIBITORS)

Supplementary Protection Certificates for DAKLINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049522	C 2015 003	Romania		PRODUCT NAME: DACLATASVIR SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTUIA, IN SPECIAL DACLATASVIR DICLORHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/14/939/001, EU/1/14/939/002, EU/1/14/939/003, EU/1/14/939/004; DATE OF NATIONAL AUTHORISATION: 20140822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/939/001, EU/1/14/939/002, EU/1/14/939/003, EU/1/14/939/004; DATE OF FIRST AUTHORISATION IN EEA: 20140822
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	211 50001-2015	Slovakia		PRODUCT NAME: DAKLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939 - EU/1/14/939/004 20140826
2049522	2015C/006	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE
2049522	524	Finland

DAKLINZA (daclatasvir) investment scenario and patent/fundamentals analysis: exclusivity, generic and biosimilar risk, litigation, and revenue exposure

Last updated: July 30, 2026

Executive summary: DAKLINZA (daclatasvir) is a legacy, direct-acting antiviral (DAA) in hepatitis C virus (HCV). Its US commercial relevance is concentrated in (1) remaining share in treated populations, (2) tender and payer pull-through in regions where price compression and generic uptake have not fully eroded spend, and (3) any residual brand value from regimen partnerships and procurement cycles. From an IP and entry-planning standpoint, the investment case is driven by the strength and remaining term of DAA composition/method/formulation patents and the degree of FDA-listed generic conversion already achieved. Key diligence hinges on Orange Book listings for daclatasvir drug products, estimated patent expiration roll-off, and whether any still-active, non-expired patent barriers exist for the specific fixed combinations (where relevant), not just the active ingredient.

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What patents protect DAKLINZA (daclatasvir) in the US and globally?

Core IP map: composition, use, and formulation

DAKLINZA’s patent estate typically spans three buckets that matter for a generic launch:

• Composition of matter for daclatasvir (active pharmaceutical ingredient, salt form, and key chemical variants).
• Method-of-treatment for HCV genotypes and combinations with other DAAs (notably NS5A inhibitor use in multi-drug regimens).
• Pharmaceutical formulations and manufacturing processes that can create launch barriers if they claim specific dosage forms, stability, or process controls.

Featured snippet answer: In DAAs like daclatasvir, the most exclusionary patents are usually composition and method-of-use claims. A generic typically attempts at-firing via Paragraph IV on method/formulation, or launches when composition-of-matter is expired.

Which jurisdictions matter for an investment decision?

• United States: FDA approvals and Orange Book listings govern launch timing risk and Paragraph IV leverage.
• Europe: EMA regulatory status and national enforcement affect commercial viability.
• Key manufacturing and sales geographies: countries where HCV treatment markets still support premium pricing longer than the US.

How many patent families likely cover DAKLINZA?

A practical diligence approach is to count distinct families under assignee groups that map to:

• daclatasvir API chemistry,
• NS5A inhibitor regimen claims,
• tablet formulation and process.

For DAKLINZA, the investment risk is that multiple generic entries have already occurred in most major markets, leaving residual upside mainly from distribution relationships, tender cycles, and geography-specific enforcement rather than from a still-tight US exclusivity moat.

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When does DAKLINZA lose exclusivity in the US?

Key drivers of “loss of exclusivity”

In the US, “loss of exclusivity” for a small molecule like daclatasvir is usually determined by:

1. Expiration of Orange Book-listed patents (composition, method, formulation).
2. Exclusivity periods tied to marketing authorization (rarely the long driver for small molecules, but can matter).
3. Whether any listed patents remain enforceable at the time of generic filing and FDA approval.

Investment-critical point: The generic threat schedule is not one date. It is a sequence of patent expirations across claim categories. Even after composition-of-matter expires, method/formulation patents can still delay or incentivize authorized generics or settlement-based delay.

What generic entry risks exist for DAKLINZA?

• ANDA conversions once Orange Book barriers lapse.
• Paragraph IV challenges if remaining patents exist and if challengers can plausibly invalidate or design around claims.
• Label design and regimen substitution that avoids protected combinations.

Featured snippet answer: Generic risk peaks when the last enforceable Orange Book patent for the marketed strength/dosage form expires or is knocked out via litigation.

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What is the Orange Book status of DAKLINZA (daclatasvir)?

How to use Orange Book listings for valuation

Orange Book listings define:

• Patent number
• Expiration date
• Patent type (3 = drug substance, 4 = formulation, 5 = method of use)
• Associated NDA/BLA

For an investment case, valuation sensitivity maps to:

• how many type 3 patents remain (hardest to design around),
• whether remaining type 5 method patents are enforceable against product label claims,
• whether the listed patents align with marketed regimen claims.

Investment implication: If Orange Book is thin at this point (few remaining or all expired), the brand value is mostly a market share and pricing story, not an IP duration story.

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What patent litigation affects DAKLINZA or its generic challenges?

Paragraph IV leverage in DAAs

For HCV DAAs, the litigation record typically tracks:

• ANDA Paragraph IV filings claiming invalidity and non-infringement,
• settlements that create delayed entry dates and sometimes cross-licensing,
• eventual outcomes where generic entry happens after patents expire or are resolved.

How to judge litigation impact on investors

The market effect usually comes from:

• settlement-induced delay (economic value for the brand),
• early injunctions (rare but possible),
• final resolution that collapses multiple listed patents at once.

Featured snippet answer: DAKLINZA’s investment risk is highest if litigation is pending against late-expiring formulation or method patents, because that determines whether brands face a delayed generic launch versus immediate price compression.

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How strong is the patent estate for daclatasvir-based regimens?

Patent strength scoring framework

A practical scorecard for DAKLINZA:

• Composition-of-matter coverage depth (number of independent claim sets and remaining term).
• Method-of-use claim breadth (genotype coverage, combination breadth, dosing schedules).
• Formulation claim enforceability (stability, bioavailability, tablet composition or coating).
• Design-around feasibility for generic challengers (salt form, polymorph, excipients, dosing instructions).

Investment conclusion: For a legacy DAA like daclatasvir, IP strength usually matters less than it did at initial launch. If composition patents are already expired and generics are widely available, valuation depends on whether protected regimen labels and distribution channels still sustain price.

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What formulations are protected by DAKLINZA patents?

Dose form and formulation barriers

Investors should separate:

• tablet formulation protections (excipients, coating, dissolution profile),
• stability and manufacturing process claims,
• pharmacokinetic/safety formulation claims (less common but possible).

Featured snippet answer: Formulation patents can delay entry only if they are still active and claim details that generics cannot replicate without infringement risk.

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How does DAKLINZA compare with other HCV DAAs on IP and market exposure?

Competitor set

In HCV, daclatasvir competes (by era and treatment regimen) with:

• NS5A inhibitors (other DAAs in the class),
• NS3/4A protease inhibitors,
• NS5B polymerase inhibitors,
• fixed-dose combinations where applicable.

Typical investment difference

• Drugs with later-expiring NS5A or combination patents can sustain higher pricing longer.
• Drugs with early generic conversions behave like commodity DAAs where brand value is tied to contracting and inventory cycles.

Investment implication: Even with strong early-era patents, DAKLINZA tends to map to a late-cycle monetization profile unless specific markets still protect it via enforceable local patent judgments.

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What is DAKLINZA’s FDA status and pathway context?

Regulatory classification

DAKLINZA is an FDA-approved small-molecule product (NDA context), used in combination HCV treatment regimens dependent on genotype, presence of cirrhosis, and prior treatment history.

Why FDA status still matters for investors

Even when IP expires, FDA status impacts:

• how quickly generics can distribute under ANDA labels,
• whether the brand retains a unique label advantage that supports payer behavior,
• whether any post-approval label expansions or restrictions influence replacement.

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What generic entry scenarios exist for daclatasvir and what do they mean for pricing?

Three market entry scenarios

1. No remaining enforceable barriers: immediate or near-immediate generic availability leads to sharp pricing compression.
2. Partial barrier coverage: generics enter for some indications/strengths but not where method-of-use patents remain enforceable.
3. Settlement-driven delayed entry: delayed generic entry keeps brand economics intact for a defined window.

Valuation linkage

• In scenario (1), brand value declines toward distributor margin and contracting leverage.
• In scenario (2), the brand may preserve price in segments where label design cannot be safely substituted.
• In scenario (3), the investment thesis is duration-based and dependent on last-mile patent expiration dates.

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Commercial fundamentals: how should investors underwrite DAKLINZA’s revenue durability?

Revenue drivers that persist post-launch

Even after generic entry:

• tender and government procurement cycles,
• payer switching friction in stable formularies,
• supply-chain lock-in via distributor agreements,
• inventory-driven continuity.

Where the fundamentals usually weaken

• HCV cure is now established standard-of-care, reducing incremental demand growth.
• Global competition compresses pricing when API becomes generic and when multiple DAAs are interchangeable clinically.
• Brand differentiation typically shifts from clinical superiority to contracting terms.

Investment lens: The brand’s future cash flows are likely dominated by volume stability and price realization rather than growth.

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Key timeline framework for an investment model (how to structure underwriting)

Build a “patent-to-price” underwriting schedule

Use a timeline that ties:

• Orange Book patent expirations to expected generic conversions,
• litigation and settlement milestones to delayed entry,
• procurement cycle lags to when price impacts hit the P&L.

Timeline template (fill with Orange Book and litigation dates in your model):

• Patent expiration A (composition): expected start of most generic conversions
• Patent expiration B (method): expected label substitution acceleration
• Settlement date: negotiated entry delay
• FDA approval date for generic: first wholesale exposure date
• First significant switching in payer/tender: when share loss shows up

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Who are the likely market entrants and challenge players?

A complete named list requires Orange Book litigation docket mapping and ANDA filing surveillance tied to daclatasvir. For investment use, the relevant question is not only “who filed,” but:

• whether challengers have final-launch capability across strengths,
• whether they can design around any method/formulation barriers,
• whether they settle or litigate to final judgment.

Investment signal: The presence of multiple ANDA filers increases the probability that pricing compresses quickly after the last enforceable barrier lapses.

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Key Takeaways

• DAKLINZA’s investment profile is a late-cycle DAA case where value is driven by remaining enforceable patent barriers, market conversion to generics, and procurement/contracting stickiness more than by clinical differentiation.
• The decisive underwriting inputs are the Orange Book patent inventory (type and expiration dates), whether any method-of-use or formulation patents remain enforceable, and whether litigation/settlements delay generic entry.
• Post-IP, fundamentals typically shift to pricing realization and tender dynamics, with HCV cure maturity limiting demand growth.
• Generic entry scenarios should be modeled against a patent-to-price timeline, not a single “loss of exclusivity” date.

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FAQs

1. How do method-of-use HCV patents affect generic label substitution for daclatasvir?
2. What settlement terms typically determine delayed ANDA entry timing for legacy DAAs?
3. Which DAKLINZA patents usually have the highest design-around resistance: composition, method, or formulation?
4. How do payer formularies and national tender cycles change the timing of post-generic price erosion?
5. What indicators show whether generics have capacity to launch across strengths and packaging for daclatasvir?

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References (APA)

No sources were provided in the prompt, and inline citations cannot be generated without verifiable data.