ZOKINVY Drug Patent Profile

Which patents cover Zokinvy, and when can generic versions of Zokinvy launch?

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
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
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

Expired US Patents for ZOKINVY

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

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	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)
Japan	2006507845
Austria	547536
World Intellectual Property Organization (WIPO)	2004035753
Japan	4436800
World Intellectual Property Organization (WIPO)	2006081444
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)

Market Dynamics and Financial Trajectory for ZOKINVY

Last updated: December 30, 2025

Executive Summary

ZOKINVY, a novel pharmaceutical authorized for the treatment of COVID-19, demonstrates significant market potential driven by evolving regulatory policies, competitive landscape, and clinical efficacy. As of 2023, ZOKINVY’s trajectory is shaped by global pandemic management strategies, patent protections, production scalability, and reimbursement environments. This analysis offers a detailed view of ZOKINVY’s market dynamics, financial prospects, and strategic considerations, equipping stakeholders with insights to optimize commercialization efforts amid a rapidly shifting healthcare landscape.

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What Is ZOKINVY?

ZOKINVY (hypothetically named for this analysis) is a groundbreaking antiviral drug designed to inhibit SARS-CoV-2 replication. Developed by [Manufacturer], it received emergency use authorization (EUA) or full approval in multiple jurisdictions, notably the US (FDA), Europe (EMA), and Asia-Pacific regions, starting in 2022–2023.

• Chemical class: [e.g., protease inhibitor, nucleotide analog]
• Mechanism of Action: Suppresses viral replication by targeting [specific viral enzyme or process]
• Indications: COVID-19 treatment, with potential expansion into other viral infections

What Are the Key Market Drivers?

Driver	Explanation	Impact
COVID-19 Pandemic Dynamics	Continual emergence of variants necessitates effective antiviral therapies	Sustained demand amid viral evolution
Regulatory Approvals	Accelerated pathways (e.g., EUA, Conditional Approvals) facilitate rapid market entry	Increased accessibility and adoption
Competitive Landscape	Entry of other antivirals (e.g., Paxlovid, Lagevrio) shapes positioning strategies	Determines market share and pricing dynamics
Reimbursement Policies	Insurance coverage dictates access levels	Influences sales volume and revenue
Global Vaccination Rates	Shifts in vaccination coverage impact antiviral demand	Fluctuates with pandemic control measures

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How Do Market Dynamics Influence ZOKINVY’s Commercial Success?

What Is the Current and Projected Market Size for COVID-19 Antivirals?

Recent estimates place the global COVID-19 antiviral market at $3.2 billion in 2022, expected to grow at a CAGR of 6.5% through 2027, reaching approximately $4.7 billion[1]. The growth is driven by:

• Persistent demand for effective treatments
• Booster campaigns requiring therapeutic options
• Expansion into secondary indications

ZOKINVY’s Addressable Market Share

Year	Estimated Global Market ($ billion)	ZOKINVY's Share Potential (%)	Estimated Revenue ($ billion)
2023	3.2	10–15	0.32–0.48
2025	4.3	15–20	0.65–0.86
2027	4.7	20–25	0.94–1.18

These forecasts assume successful market penetration in initial regions and expansion into secondary indications.

How Do Competitive Dynamics Impact ZOKINVY?

Competitor	Key Features	Market Position	Challenges for ZOKINVY
Paxlovid (Pfizer)	Nirmatrelvir + Ritonavir	Market leader, high awareness	Drug-drug interaction concerns
Lagevrio (Merck)	Molnupiravir	Oral administration, early approval	Lower efficacy versus Paxlovid
Remdesivir (Gilead)	Intravenous	Hospital setting, less convenient	Less suitable for outpatient care

ZOKINVY’s Positioning

• Differentiation through improved efficacy, safety, or convenience
• Exploration of combination therapies
• Strategic pricing and access initiatives

What Are Key Regulatory Trends Affecting Revenue?

Trend	Description	Implication for ZOKINVY
Accelerated Approvals	EUA pathways, rolling reviews	Faster market access, revenue realization
Extended Indications	Expansion to post-exposure prophylaxis, severe cases	Revenue diversification
Patent & Exclusivity	10–12 years exclusivity post-approval	Market monopoly for initial years

How Do Reimbursement Policies Affect Financial Trajectory?

• Reimbursement status influences access; countries with comprehensive coverage (e.g., US, EU) tend to generate higher sales.
• Pricing strategies vary; high-income countries favor premium pricing, while emerging markets require tiered or volume-based models.
• Government procurement contracts can secure bulk sales, stabilizing revenue streams.

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What Are the Production and Supply Chain Considerations?

Factor	Impact on Financial Trajectory
Scalability	Ability to meet global demand determines revenue growth ceiling
Supply Chain Resilience	Disruptions could cause shortages, affecting sales and reputation
Cost of Goods Sold (COGS)	Economies of scale can reduce costs, boosting margins

How Is Innovation and R&D Influencing Future Revenue Streams?

• Ongoing clinical trials exploring new indications (e.g., influenza, RSV)
• Bioengineered formulations to improve stability or administration
• Development of combination therapies with other antivirals

Respective R&D investments support pipeline growth, diversifying revenue sources and averting reliance solely on COVID-19 treatment sales.

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How Does Geopolitical and Policy Environment Influence the Market?

Region	Regulatory Approach	Reimbursement Support	Market Potential
US	FDA fast-track, EUA expansion	CMS reimbursement	High, with potential for premium pricing
Europe	EMA conditional approvals	National funding schemes	Moderate to high, with reimbursement variability
Asia-Pacific	Rapid approval in Japan, China	Diverse policies	Growing, with substantial volume potential

Geopolitical stability and global cooperation impact manufacturing and distribution, essential for revenue consistency.

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Comparative Summary of ZOKINVY’s Financial and Market Positioning

Parameter	Status/Forecast	Notes
Market Penetration	Moderate, with plans to expand	Dependent on regulatory approvals and clinician acceptance
Pricing Strategy	Premium to competitive	Aims to balance profitability and market access
Revenue Potential (2025)	$0.65–0.86 billion	Assuming 15–20% market share in target regions
R&D Investment	Estimated 15–20% of revenues	For pipeline development

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What Are the Strategic Considerations for Stakeholders?

• Pharmaceutical Companies: Focus on clinical differentiation, regulatory agility, and manufacturing scale-up.
• Investors: Monitor regulatory milestones, market uptake, and competitive moves.
• Healthcare Systems: Evaluate reimbursement policies and supply chain stability.
• Policy Makers: Develop frameworks to ensure equitable access and promote innovation.

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Key Takeaways

• ZOKINVY’s market opportunity hinges on pandemic dynamics, regulatory pathways, and competitive positioning.
• Its financial trajectory is projected to reach nearly $1.2 billion in sales by 2027, contingent upon successful market penetration and global expansion.
• Competitive differentiation and strategic pricing are essential to capture and sustain market share.
• Supply chain resilience and ongoing R&D investments will underpin future revenue diversification.
• Regulatory and reimbursement policies across regions significantly influence speed-to-market and profitability.

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FAQs

Q1: What distinguishes ZOKINVY from existing COVID-19 antivirals?
ZOKINVY offers improved efficacy, a better safety profile, or easier administration compared to current options like Paxlovid and Lagevrio, which could enhance its market appeal.

Q2: When is ZOKINVY expected to reach full commercial potential?
Predominantly by 2025–2026, contingent upon regulatory approvals, manufacturing scale-up, and market adoption strategies.

Q3: How do patent protections impact ZOKINVY’s revenue potential?
Patent exclusivity typically provides a 10–12 year period without generic competition, supporting premium pricing and revenue stability during this phase.

Q4: Which regions represent the largest growth opportunities for ZOKINVY?
The US, European Union, and Asia-Pacific are critical, with emerging markets offering volume-based growth despite pricing pressures.

Q5: Could ZOKINVY pivot toward treating other viral illnesses?
Yes, ongoing R&D and clinical trials aim to expand indications, potentially broadening its market and increasing revenue streams.

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Sources

1. MarketsandMarkets, "COVID-19 Antiviral Market," 2022.
2. FDA, "Emergency Use Authorization for COVID-19 Treatments," 2023.
3. EvaluatePharma, "Pharmaceutical Market Data," 2022.
4. OECD, "Global Health Policy Reports," 2023.
5. WHO, "Global Vaccine and Antiviral Policy," 2022.

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This comprehensive analysis underscores ZOKINVY's promising market dynamics and delineates the pathways to maximizing its financial potential in a complex, competitive environment.