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PITOLISANT HYDROCHLORIDE

ANDA

PITOLISANT HYDROCHLORIDE | A218495 | NOVITIUM PHARMA LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: WAKIX(TE code: AB)

API Supply Chain7 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

NURAY CHEMICALS PVT LTDPITOLISANT HYDROCHLORIDE

DMF 368592022

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPITOLISANT HYDROCHLORIDE SOLID DISPERSION

DMF 377532022

MSN LABORATORIES PRIVATE LTDPITOLISANT

DMF 381312023

NURAY CHEMICALS PRIVATE LTDPITOLISANT HYDROCHLORIDE SD

DMF 381742023

DASAMI LAB PRIVATE LTDPITOLISANT HYDROCHLORIDE

DMF 383072023

EMNAR PHARMA PRIVATE LTDPITOLISANT HYDROCHLORIDE

DMF 391262023

NEW HORIZON PHARMA US INCPITOLISANT HYDROCHLORIDE IN-HOUSE

DMF 397212024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 9, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 4.45MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 21, 2026

No patent or exclusivity listings for this strength.

#002 — EQ 17.8MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 21, 2026