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 |
US Patents and Regulatory Information for lonafarnib
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
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
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 |