Lonafarnib - Generic Drug Details

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What are the generic drug sources for lonafarnib and what is the scope of freedom to operate?

Lonafarnib is the generic ingredient in one branded drug marketed by Eiger Biopharms and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lonafarnib has nine patent family members in six countries.

Summary for lonafarnib

International Patents:	9
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	32
Patent Applications:	3,962
What excipients (inactive ingredients) are in lonafarnib?	lonafarnib excipients list
DailyMed Link:	lonafarnib at DailyMed

Recent Clinical Trials for lonafarnib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Soroka University Medical Center	Phase 3
Eiger BioPharmaceuticals	Phase 3
Boston Children’s Hospital	Phase 1/Phase 2

See all lonafarnib clinical trials

US Patents and Regulatory Information for lonafarnib

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eiger Biopharms	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-001	Nov 20, 2020		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Eiger Biopharms	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-001	Nov 20, 2020		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Eiger Biopharms	ZOKINVY	lonafarnib	CAPSULE;ORAL	213969-002	Nov 20, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for lonafarnib

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for lonafarnib

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Country	Patent Number	Title	Estimated Expiration
Japan	4436800		See Plans and Pricing
Austria	547536		See Plans and Pricing
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)	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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