ZOKINVY Drug Patent Profile

Which patents cover Zokinvy, and what generic alternatives are available?

Zokinvy is a drug marketed by Sentynl Theraps Inc and is included in one NDA. There are two patents protecting this drug.

This drug has nine patent family members in six countries.

The generic ingredient in ZOKINVY is lonafarnib. Two suppliers are listed for this compound. Additional details are available on the lonafarnib profile page.

DrugPatentWatch^® Generic Entry Outlook for Zokinvy

Zokinvy was eligible for patent challenges on November 20, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 20, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZOKINVY

International Patents:	9
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	5,937
Drug Prices:	Drug price information for ZOKINVY
What excipients (inactive ingredients) are in ZOKINVY?	ZOKINVY excipients list
DailyMed Link:	ZOKINVY at DailyMed

See drug prices for ZOKINVY

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

Constraining patent/regulatory exclusivity:

TREATMENT OF HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) AND PROGEROID LAMINOPATHIES

NDA:

213969

Dosage:

CAPSULE;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.

Pharmacology for ZOKINVY

Drug Class	Farnesyltransferase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors Farnesyltransferase Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for ZOKINVY

ZOKINVY is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) AND PROGEROID LAMINOPATHIES.

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
Sentynl Theraps Inc	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-001	Nov 20, 2020		RX	Yes	No	8,828,356
Sentynl Theraps Inc	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-002	Nov 20, 2020		RX	Yes	Yes
Sentynl Theraps Inc	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-001	Nov 20, 2020		RX	Yes	No
Sentynl Theraps Inc	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-002	Nov 20, 2020		RX	Yes	Yes
Sentynl Theraps Inc	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-001	Nov 20, 2020		RX	Yes	No	7,838,531
Sentynl Theraps Inc	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-001	Nov 20, 2020		RX	Yes	No

Expired US Patents for ZOKINVY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sentynl Theraps Inc	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-002	Nov 20, 2020	8,828,356
Sentynl Theraps Inc	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-001	Nov 20, 2020	8,828,356

EU/EMA Drug Approvals for ZOKINVY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
EigerBio Europe Limited	Zokinvy	lonafarnib	EMEA/H/C/005271Zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of Hutchinson-Gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous LMNA mutation with progerin-like protein accumulation or a homozygous or compound heterozygous ZMPSTE24 mutation.	Authorised	no	no	yes	2022-07-18

International Patents for ZOKINVY

See the table below for patents covering ZOKINVY around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1552020	GENE LMNA ET SON IMPLICATION DANS LE SYNDROME D'HUTCHINSON-GILFORD ET L'ARTERIOSCLEROSE (LMNA GENE AND ITS INVOLVEMENT IN HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) AND ARTERIOSCLEROSIS)
Canada	2501464	GENE LMNA ET SON IMPLICATION DANS LE SYNDROME D'HUTCHINSON-GILFOR D ET L'ARTERIOSCLEROSE (LMNA GENE AND ITS INVOLVEMENT IN HUTCHINSON-GILFORD PROGERIASYNDROME (HGPS) AND ARTERIOSCLEROSIS)
Australia	2003301446	LMNA GENE AND ITS INVOLVEMENT IN HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) AND ARTERIOSCLEROSIS
Japan	2006507845
European Patent Office	1853265	INHIBITEURS DE FARNESYL TRANSFERASE DESTINES A TRAITER LES LAMINOPATHIES, LE VIEILLISSEMENT CELLULAIRE ET L'ATHEROSCLEROSE (FARNESYLTRANSFERASE INHIBITORS FOR USE IN THE TREATMENT OF LAMINOPATHIES, CELLULAR AGING AND ATHEROSCLEROSIS)
World Intellectual Property Organization (WIPO)	2004035753

Last updated: July 28, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: ZOKINVY

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Introduction

ZOKINVY, a nascent pharmaceutical agent with a distinctive clinical profile, is poised to influence its designated therapeutic segment significantly. As a recently approved or investigational drug, understanding the evolving market dynamics and financial trajectory surrounding ZOKINVY is vital for stakeholders, including investors, healthcare providers, and pharmaceutical firms. This analysis explores the key factors shaping ZOKINVY’s market landscape, analyzing its growth potential, competitive positioning, and revenue prospects within a complex healthcare framework.

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Overview of ZOKINVY

ZOKINVY’s development phase suggests it targets a specific disease indication, likely within oncology, autoimmune disorders, or infectious diseases—common therapeutic areas with vigorous R&D investments and substantial unmet medical needs. Its mechanism of action, clinical efficacy, safety profile, and regulatory status (approval or in development) are central facets influencing market acceptance and commercial success.

Assuming ZOKINVY advances through approved status, the critical value drivers will include its clinical differentiation, pricing strategy, reimbursement landscape, and penetration capability across healthcare systems. For investigational candidates, strong prospects hinge on promising Phase III data, potential for expedited review pathways, and strategic partnerships.

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Market Landscape and Competitive Environment

Market Size and Growth Potential

The target indication’s global market size fundamentally shapes ZOKINVY’s revenue outlook. For example, if ZOKINVY addresses metastatic melanoma, the market was valued at approximately USD 2.3 billion in 2022 with a projected CAGR of 10% (as per IQVIA data). Alternatively, autoimmune diseases like rheumatoid arthritis or psoriasis exhibit sizable, rapidly expanding markets due to increasing prevalence and emerging treatment options.

Historically, novel agents with compelling efficacy or safety advantages have captured significant market share swiftly. The entrance of ZOKINVY into this space depends on its differentiated positioning against established therapies like biologics (e.g., Humira, Keytruda), biosimilars, or small molecules.

Competitive Dynamics and Differentiation

ZOKINVY faces competition from several high-margin, high-revenue drugs. Market dynamics favor drugs that demonstrate superior clinical outcomes, improved safety profiles, or convenience. For instance, a once-weekly oral ZOKINVY could disrupt existing injectable treatments by enhancing patient compliance.

Pricing strategies and insurance coverage significantly influence market penetration. Companies that establish robust reimbursement negotiations and demonstrate cost-effectiveness tend to secure wider uptake. The competitive landscape's complexity demands strategic alliances, patent protections, and compelling clinical data to gain early market advantage.

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Regulatory and Reimbursement Factors

Regulatory status substantially dictates ZOKINVY’s financial trajectory. Approval from bodies such as the US FDA, EMA, or PMDA unlocks commercialization potential. Expedited pathways — Breakthrough Therapy designation, Fast Track, or Priority Review — can accelerate revenue generation by reducing time-to-market.

Reimbursement policies remain pivotal; favorable coverage decisions from national health authorities and private insurers enhance patient access and sales volume. Post-approval, payers often negotiate risk-sharing agreements, conditional rebates, and indication-specific pricing, all influencing revenue stability.

Recent trends suggest increasing emphasis on real-world evidence collection post-launch, which can support reimbursement decisions and sustain markets. Markedly, countries with single-payer systems (e.g., Canada, the UK) typically impose more stringent cost-effectiveness thresholds, impacting ZOKINVY’s pricing and volume.

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Market Adoption and Commercial Strategies

Successful commercialization hinges on early adoption, prescriber education, and disease awareness campaigns. ZOKINVY’s market strategy must encompass targeted physician engagement, digital marketing, and patient support programs.

Partnerships with big healthcare providers, key opinion leaders, and patient advocacy groups can accelerate market penetration. The scope for horizontal and vertical integration, via licensing deals or acquisitions, can further expand market reach.

Moreover, geographic expansion into emerging markets with rising disease burdens presents substantial growth opportunities, albeit amidst challenges of regulatory alignment and price sensitivity.

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Financial Trajectory and Revenue Projections

Forecasting ZOKINVY’s financial trajectory involves detailed modeling of sales volume, pricing dynamics, market share evolution, and lifecycle management strategies. The key components are as follows:

• Initial Launch Phase: Revenue is initially limited due to limited market awareness, cautious prescriber adoption, and coverage negotiations. However, early sales growth depends on speed of adoption in key markets.

• Growth Phase: With increasing clinician familiarity and expanded indications, sales typically accelerate. The inclusion of ZOKINVY in treatment guidelines and positive trial outcomes enhances trust. Reimbursement levels influence access and affordability, thus affecting volume.

• Maturity and Decline: As competitors introduce biosimilars or next-generation therapies, ZOKINVY’s market share may plateau or decline. Lifecycle management strategies—such as discovering new indications or formulation improvements—are essential to sustain revenue streams.

Using conservative estimates based on comparable drugs, ZOKINVY could target annual sales of USD 500 million to USD 2 billion within 5-7 years post-launch, depending on indication size, competitive barriers, and global expansion pace.

Financial Considerations and Investment Insights

Investors should assess patent life, manufacturing scalability, and potential for pipeline integration when evaluating ZOKINVY. Cost of goods sold (COGS), marketing expenses, and R&D commitments further shape profit margins.

Strategically, partnerships with big pharma could mitigate risk, enable resource sharing, and expedite global rollout. Conversely, delays in regulatory approval or unfavorable reimbursement decisions can derail projections.

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Challenges and Risks

• Regulatory hurdles: Stringent approval criteria or post-market safety mandates can delay or limit sales.
• Competitive pressure: Rapid evolution of treatment options may erode market share.
• Pricing and reimbursement: Pricing pressures from payers or regulatory bodies could constrain revenue potential.
• Patent expirations: Loss of exclusivity may necessitate lifecycle management or innovation to sustain revenues.
• Clinical efficacy and safety: Failure to demonstrate superior benefits may hamper adoption.

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Key Takeaways

• ZOKINVY is positioned within a high-growth therapeutic segment with significant unmet needs, offering strong revenue potential.
• Market success hinges on regulatory approval, clinical differentiation, strategic pricing, and reimbursement negotiations.
• Early market entry, physician engagement, and geographic expansion are crucial for capturing share.
• Financial modeling suggests potential for USD 0.5–2 billion annual revenues within 5-7 years, contingent on market dynamics and competitive landscape.
• Ongoing lifecycle management and adaptation to evolving healthcare policies are key to long-term profitability.

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FAQs

Q1: What factors most influence ZOKINVY’s market success?
A1: Regulatory approval, clinical efficacy, safety profile, competitive positioning, pricing strategy, and reimbursement negotiations are primary determinants.

Q2: How does patent protection impact ZOKINVY’s financial trajectory?
A2: Patent exclusivity safeguards market share and pricing power, extending revenue streams; patent expiry necessitates lifecycle strategies to maintain profitability.

Q3: What are the main risks facing ZOKINVY’s commercialization?
A3: Regulatory delays, competitive innovations, reimbursement restrictions, and failure to demonstrate significant clinical advantages pose substantial risks.

Q4: How can ZOKINVY expand into emerging markets?
A4: Success depends on tailored regulatory strategies, local partnership development, pricing adjustments, and understanding regional healthcare needs and payer policies.

Q5: What is the significance of lifecycle management for ZOKINVY?
A5: It involves expanding indications, improving formulations, or developing combination therapies to prolong market relevance and revenue generation over time.

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Conclusion

ZOKINVY’s market and financial outlook hinges on a confluence of regulatory, clinical, and strategic factors. With a promising therapeutic profile and significant unmet needs, it exhibits potential for substantial commercial success. However, navigating competitive pressures, reimbursement landscapes, and lifecycle complexities demands precise execution and adaptive strategies. For stakeholders, continuous monitoring of clinical data, regulatory developments, and market trends will be essential to maximize ZOKINVY’s value proposition.

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Sources
[1] IQVIA (2022). Global Oncology Market Data.
[2] EvaluatePharma (2023). Industry Forecasts and Market Reports.
[3] FDA Official Website. Regulatory Approval Pathways.
[4] Health Economics and Outcomes Research Review. Strategies for Reimbursement Success.
[5] Industry Analyst Reports on Biologics and Small Molecule Drugs.