Question 1

Is there a generic for Eflornithine hydrochloride?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Eflornithine hydrochloride. It is available as 3 brand (NDA) applications.

Question 2

What is the reference-listed drug for Eflornithine hydrochloride?

Accepted Answer

IWILFIN (NDA 215500, USWM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Eflornithine hydrochloride?

Accepted Answer

The Orange Book lists 1 patent against Eflornithine hydrochloride products, with the earliest listed expiry in 2036. 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 Eflornithine hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Eflornithine hydrochloride. 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 Eflornithine hydrochloride are approved?

Accepted Answer

Eflornithine hydrochloride is approved in the following dosage forms: cream, injectable, tablet.

Product	Applicant	Application	TE	Approved
IWILFINRLD	USWM	NDA 215500	—	Dec 13, 2023
VANIQARLD	ABBVIE	NDA 021145	—	Jul 27, 2000
ORNIDYL	SANOFI AVENTIS US	NDA 019879	—	Nov 28, 1990

Eflornithine hydrochloride

Brand (NDA) products · cream, injectable, tablet

Marketing exclusivity (2)

Listed patents (1)

Eflornithine hydrochloride — frequently asked questions

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