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 is one patent protecting this drug.

This drug has nine patent family members in six countries.

The generic ingredient in ZOKINVY is lonafarnib. One supplier is 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:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	5,945
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 one US patents and one FDA Regulatory Exclusivity.

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	7,838,531
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	7,838,531

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	8,828,356
Sentynl Theraps Inc	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-002	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
Austria	547536
Australia	2003301446	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)
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)
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)

ZOKINVY (zokinvoy): Market dynamics and financial trajectory, exclusivity and competitive risks

Last updated: July 30, 2026

ZOKINVY is an on-market product with limited public, drug-specific financial disclosure. No complete, verifiable set of revenue figures, payer coverage, utilization drivers, pricing history, or FDA labeling milestones is available in the supplied context. As a result, a complete and accurate market-dynamics and financial-trajectory analysis cannot be produced.

What is ZOKINVY and where is it positioned commercially?

Featured snippet: ZOKINVY’s commercial positioning depends on its approved indication, route of administration, and payer coverage outcomes, none of which are provided here.

What therapeutic area and dosing profile determine uptake?

Featured snippet: Uptake typically tracks indication breadth, line of therapy placement, dosing frequency, and administration setting.

Which endpoints matter for reimbursement?

Featured snippet: Reimbursement usually follows evidence strength on clinically meaningful endpoints (overall survival, progression-free survival, response rate, durability, safety) tied to payer medical-policy criteria.

How are buyers using ZOKINVY: hospitals, clinics, or home settings?

Featured snippet: Real-world uptake for pharmaceuticals hinges on site-of-care and operational fit.

What site-of-care rules shape volume growth?

Featured snippet: Coverage and utilization are driven by prior authorization requirements, clinical criteria, infusion capacity, and formulary management.

What payer mix drives net revenue?

Featured snippet: Net price is a function of commercial formulary position and government reimbursement.

What is ZOKINVY’s pricing and net revenue trajectory?

Featured snippet: Pricing trajectory depends on launch net price, discounting, rebates, and channel mix.

How do discounts and rebates compress list price?

Featured snippet: Pharmacy benefit versus medical benefit mix changes rebate exposure and net price mechanics.

Is ZOKINVY branded-only or facing early competition?

Featured snippet: Competitive pressure can move net price quickly once any generic or authorized alternative enters.

When does ZOKINVY lose exclusivity?

Featured snippet: Exclusivity loss date requires Orange Book or equivalent regulatory exclusivity listings plus patent term and any pediatric exclusivity extensions, none of which are included here.

What patents protect ZOKINVY?

Featured snippet: Patent protection must be verified via Orange Book listings (drug substance and formulation, method-of-use, and manufacturing claims).

How many exclusivity layers exist: patent, exclusivity, and market exclusivity?

Featured snippet: For small molecules, investors track patent expiration, Orange Book “grants,” and regulatory exclusivities; for biologics, track BLA reference product exclusivity and biosimilar pathways.

What Orange Book status does ZOKINVY have?

Featured snippet: Orange Book status determines whether generics can file ANDAs and what patent numbers are listed for paragraph IV challenges.

Which patent numbers are listed and for which strengths/forms?

Featured snippet: Strength-specific and dosage-form-specific listings can limit generic launch timing.

Does ZOKINVY have exclusivity not tied to patents?

Featured snippet: Some exclusivities attach to exclusivity codes rather than patent expiration.

What patent litigation affects ZOKINVY’s generics or competitors?

Featured snippet: Litigation risk requires docket-level confirmation of paragraph IV ANDA/BLA challenges, settlements, and relevant claim constructions.

Have any companies filed paragraph IV certifications?

Featured snippet: Identifying filers and certifications determines the earliest theoretical generic entry.

What settlements cap revenue exposure?

Featured snippet: Reverse-payment and “carve-out” settlements set effective entry dates and product-claim triggers.

What generic entry risks exist for ZOKINVY?

Featured snippet: Generic risk depends on which patents are enforceable, what claims remain, and whether design-arounds can enter before the last listed patent expires.

What formulations could delay entry?

Featured snippet: If formulation or method-of-use patents dominate, generic entry may be delayed or limited.

How strong is the remaining patent estate?

Featured snippet: Patent strength must be measured by claim scope, remaining term, prosecution history, and litigation outcomes.

How does ZOKINVY compare with competing drugs in the same class?

Featured snippet: Competitive dynamics depend on mechanism, safety profile, outcomes, administration burden, and payer preferences.

Which brands or generics compete directly?

Featured snippet: Substitution rates often depend on whether competitors are therapeutically interchangeable and formulary-preferred.

What is the likely impact on share if a competitor launches?

Featured snippet: Share shifts follow relative effectiveness, dosing convenience, and reimbursement coverage.

FDA pathway status and regulatory milestones: what does it imply for time-to-competition?

Featured snippet: Regulatory pathway influences launch timing and future line extensions.

Is ZOKINVY under accelerated approval, standard, or supplemental review?

Featured snippet: Approval pathway ties to evidence requirements and post-marketing commitments.

Are there label expansions that change reimbursement?

Featured snippet: Label expansions can expand eligible patient pools and reduce payer pushback.

What manufacturing and IP barriers protect ZOKINVY from rapid competition?

Featured snippet: Barriers include manufacturing process patents, sterile or controlled manufacturing requirements, and proprietary intermediates.

What process patents could block generic manufacturing?

Featured snippet: Process controls can trigger design-arounds or delay filings.

Are there REMS or distribution controls?

Featured snippet: REMS can slow substitution by changing provider workflows.

Key Takeaways

• A complete market-dynamics and financial-trajectory profile for ZOKINVY cannot be produced from the provided information without verifiable revenue, payer, pricing, FDA, and patent-or-exclusivity data.
• Any defensible analysis must ground on Orange Book/regulatory listings, litigation dockets, settlement terms, and audited or consistently reported financial disclosures tied to ZOKINVY.

FAQs

1. What does ZOKINVY’s payer coverage look like across commercial and Medicare formularies?
2. What are the most important real-world utilization drivers for ZOKINVY (site of care, prior authorization, patient selection)?
3. When is ZOKINVY’s earliest plausible generic entry date under Orange Book patent listings?
4. Has any company filed a paragraph IV ANDA against ZOKINVY, and what settlement terms control launch?
5. What product attributes (dose frequency, administration route, safety monitoring) most influence ZOKINVY’s competitive share?

References

1. Orange Book: U.S. Food and Drug Administration. (n.d.). Drugs@FDA / Orange Book. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
3. FDA. (n.d.). Biosimilars. https://www.fda.gov/drugs/biosimilars

DrugChatter Q&A for ZOKINVY

European medicines agency zokinvy product information 2024?
Dailymed zokinvy lonafarnib label updated 2024?
Dailymed zokinvy lonafarnib prescribing information 2024?