Question 1

Is there a generic for Pitolisant hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Pitolisant hydrochloride?

Accepted Answer

WAKIX (NDA 211150, HARMONY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Pitolisant hydrochloride?

Accepted Answer

The Orange Book lists 3 patents against Pitolisant hydrochloride products, with the earliest listed expiry in 2026. 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 Pitolisant hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 10 marketing-exclusivity periods for Pitolisant 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 Pitolisant hydrochloride are approved?

Accepted Answer

Pitolisant hydrochloride is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8354430	Feb 06, 2026	4 mo ago	U-1101
8486947	Sep 26, 2029	in 3 yr 4 mo	U-1101
8207197	Mar 07, 2030	in 3 yr 9 mo	SubstanceProduct

Pitolisant hydrochloride

Brand (NDA) products · tablet

Marketing exclusivity (10)

Listed patents (3)

Pitolisant hydrochloride — frequently asked questions

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