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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. 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:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	4,867
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

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/005271 Zokinvy 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
World Intellectual Property Organization (WIPO)	2004035753
Japan	4436800
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)
Austria	547536
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)

ZOKINVY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zokinvy (Lonafarnib)

Introduction

Zokinvy (lonafarnib) is a groundbreaking drug approved for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS) and processing-deficient progeroid laminopathies (PDPL), ultra-rare and fatal genetic premature aging diseases. Here, we delve into the market dynamics and financial trajectory of this critical medication.

Regulatory Approvals and Market Expansion

Zokinvy has secured significant regulatory approvals, marking its entry into various global markets. It was first approved by the U.S. Food and Drug Administration (FDA) in November 2020. Subsequently, it received approvals in the European Union and Great Britain in 2022, and in Japan in January 2024[1][5].

Global Acquisition and Ownership

In a significant development, Sentynl Therapeutics, a Zydus Group company, acquired the global rights to Zokinvy from Eiger BioPharmaceuticals in May 2024. This acquisition expands Sentynl's portfolio of biopharmaceuticals for rare and ultra-rare diseases, underscoring the company's commitment to supporting patients with devastating conditions[1].

Revenue Performance

Zokinvy has generated notable revenue since its commercial launch. In the first quarter of 2023, it achieved net product revenue of $4.1 million, and for the full year 2022, it brought in $12 million. The revenue growth is partly attributed to sales in Germany and the absence of such sales in the same period of the previous year[2][4].

Market Position and Competition

Zokinvy is the first and only FDA-approved treatment for progeria, giving it a unique market position. Despite its exclusivity, the drug's patents are set to expire in 2023 and 2024, although exclusivity clauses extend into 2027. Currently, there are no immediate competitors, which helps maintain its market dominance[4].

Financial Performance of Eiger BioPharmaceuticals

Eiger BioPharmaceuticals, the original developer and commercializer of Zokinvy, has faced financial challenges. The company reported a net loss of $20.7 million in the second quarter of 2023, compared to a net loss of $21.9 million in the same period of 2022. Despite these losses, Eiger has a cash position of $53.6 million as of June 30, 2023, which is expected to extend its cash runway into the fourth quarter of 2024[2].

Cost and Expense Management

Eiger BioPharmaceuticals has implemented cost-cutting measures, including a 25% reduction in workforce and reductions in out-of-pocket spending related to its hepatitis delta (HDV) development program. These efforts have led to a decrease in selling, general, and administrative expenses from $7.0 million in Q2 2022 to $5.5 million in Q2 2023[2].

Portfolio Prioritization and Future Focus

Eiger BioPharmaceuticals has undergone a portfolio prioritization review and decided to focus its development efforts on avexitide for hyperinsulinemic hypoglycemia indications, such as post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism. While Zokinvy remains a commercial product, the company's strategic shift aims to leverage the potential of avexitide in metabolic diseases[3].

Impact of Acquisition on Sentynl Therapeutics

The acquisition of Zokinvy by Sentynl Therapeutics marks a significant milestone in expanding its portfolio of medicines for rare and orphan diseases. Sentynl will be responsible for the manufacture and commercialization of Zokinvy globally, furthering its mission to support patients with rare conditions. The acquisition was finalized at a net base price of $45.2 million, subject to certain purchase price adjustments[1].

Future Outlook

Given the unique market position of Zokinvy and the lack of immediate competitors, the drug is expected to continue generating revenue for Sentynl Therapeutics. However, the eventual expiration of its exclusivity clauses and potential generic competition will be critical factors in its long-term financial trajectory.

Key Takeaways

• Regulatory Approvals: Zokinvy has received approvals in the U.S., EU, Great Britain, and Japan.
• Revenue Performance: Generated $12 million in revenue for 2022 and $4.1 million in Q1 2023.
• Market Position: Unique market position with no immediate competitors.
• Financial Performance: Eiger BioPharmaceuticals faced financial challenges but managed costs to extend cash runway.
• Acquisition: Sentynl Therapeutics acquired global rights to Zokinvy, expanding its rare disease portfolio.
• Future Focus: Eiger BioPharmaceuticals is shifting focus to avexitide for metabolic diseases.

FAQs

What is Zokinvy used for?

Zokinvy (lonafarnib) is used for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS) and processing-deficient progeroid laminopathies (PDPL), which are ultra-rare and fatal genetic premature aging diseases.

Who currently owns the rights to Zokinvy?

The global rights to Zokinvy have been acquired by Sentynl Therapeutics, a Zydus Group company, from Eiger BioPharmaceuticals.

What are the key regulatory approvals for Zokinvy?

Zokinvy has been approved by the U.S. FDA, the European Commission, and regulatory bodies in Great Britain and Japan.

How has Zokinvy performed financially?

Zokinvy generated $12 million in revenue for 2022 and $4.1 million in the first quarter of 2023. It remains a significant revenue source despite the financial challenges faced by Eiger BioPharmaceuticals.

What are the future prospects for Zokinvy?

Zokinvy is expected to continue generating revenue for Sentynl Therapeutics, but its long-term financial trajectory will depend on the expiration of its exclusivity clauses and potential generic competition.

How does the acquisition by Sentynl Therapeutics impact Zokinvy's market presence?

The acquisition by Sentynl Therapeutics expands its portfolio of medicines for rare and orphan diseases, ensuring continued support and commercialization of Zokinvy globally.

Sources

1. Sentynl Therapeutics Announces Global Acquisition of Zokinvy (lonafarnib) for Treatment of Hutchinson-Gilford Progeria Syndrome from Eiger BioPharmaceuticals. PR Newswire.
2. Eiger BioPharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Business Update. PR Newswire.
3. Eiger BioPharmaceuticals to Focus on Metabolic Diseases with Avexitide; David Apelian Takes Helm as CEO. PR Newswire.
4. The Biopharma Patent Cliff: 9 Drugs Losing Exclusivity by the End of 2023. BioSpace.
5. Eiger BioPharmaceuticals, Inc. 10K 2022. ProxyVote.