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PONATINIB HYDROCHLORIDE

ANDA

PONATINIB HYDROCHLORIDE | A215893 | APOTEX INC

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
TAKEDA PHARMACEUTICALS AMERICA, INC. et al v. APOTEX, INC. 2:2021cv12998 3 patentsANDA 215893ponatinib hydrochloride	D.N.J.	2021-06-25	Terminated 2023-02-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain3 active DMFs

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

MATRIX PHARMACORP PRIVATE LTDPONATINIB HYDROCHLORIDE

DMF 323402018

ZHEJIANG LEPU PHARMACEUTICAL CO LTDPONATINIB HYDROCHLORIDE

DMF 354132020

MSN LABORATORIES PRIVATE LTDPONATINIB HYDROCHLORIDE

DMF 378542022

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 28, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 15MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 14, 2023

No patent or exclusivity listings for this strength.

#002 — EQ 45MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 14, 2023