LONAFARNIB - Generic Drug Details
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What are the generic sources for lonafarnib and what is the scope of patent protection?
Lonafarnib
is the generic ingredient in one branded drug marketed by Sentynl Theraps Inc 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.
One supplier is listed for this compound.
Summary for LONAFARNIB
International Patents: | 9 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 33 |
Patent Applications: | 4,305 |
What excipients (inactive ingredients) are in LONAFARNIB? | LONAFARNIB excipients list |
DailyMed Link: | LONAFARNIB at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LONAFARNIB
Generic Entry Date for LONAFARNIB*:
Constraining patent/regulatory exclusivity:
TREATMENT OF HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) AND PROGEROID LAMINOPATHIES 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.
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 |
Pharmacology for LONAFARNIB
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sentynl Theraps Inc | ZOKINVY | lonafarnib | CAPSULE;ORAL | 213969-002 | Nov 20, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sentynl Theraps Inc | ZOKINVY | lonafarnib | CAPSULE;ORAL | 213969-001 | Nov 20, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sentynl Theraps Inc | ZOKINVY | lonafarnib | CAPSULE;ORAL | 213969-001 | Nov 20, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LONAFARNIB
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sentynl Theraps Inc | ZOKINVY | lonafarnib | CAPSULE;ORAL | 213969-001 | Nov 20, 2020 | ⤷ Sign Up | ⤷ Sign Up |
Sentynl Theraps Inc | ZOKINVY | lonafarnib | CAPSULE;ORAL | 213969-002 | Nov 20, 2020 | ⤷ Sign Up | ⤷ Sign Up |
Sentynl Theraps Inc | ZOKINVY | lonafarnib | CAPSULE;ORAL | 213969-002 | Nov 20, 2020 | ⤷ Sign Up | ⤷ Sign Up |
Sentynl Theraps Inc | ZOKINVY | lonafarnib | CAPSULE;ORAL | 213969-001 | Nov 20, 2020 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 | 2006507845 | ⤷ Sign Up | |
Austria | 547536 | ⤷ Sign Up | |
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) | ⤷ Sign Up |
Japan | 4436800 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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