Question 1

Is there a generic for Lonafarnib?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Lonafarnib. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Lonafarnib?

Accepted Answer

ZOKINVY (NDA 213969, SENTYNL THERAPS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Lonafarnib?

Accepted Answer

The Orange Book lists 1 patent against Lonafarnib products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Lonafarnib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Lonafarnib. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Lonafarnib are approved?

Accepted Answer

Lonafarnib is approved in the following dosage form: capsule.

Lonafarnib

Brand (NDA) products · capsule

Marketing exclusivity (2)

Listed patents (1)

Lonafarnib — frequently asked questions

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