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FOSTAMATINIB DISODIUM

ANDA

FOSTAMATINIB DISODIUM | A217329 | ANNORA PHARMA PRIVATE LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: TAVALISSE(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
RIGEL PHARMACEUTICALS, INC. v. ANNORA PHARMA PRIVATE LTD. et al 2:2022cv04732 5 patentsANDA 217329fostamatinib disodium hexahydrate	D.N.J.	2022-07-25	Terminated 2025-03-26	—

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

HETERO LABS LTDFOSTAMATINIB DISODIUM HEXAHYDRATE

DMF 366292022

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 22, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 100MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 17, 2026

No patent or exclusivity listings for this strength.

#002 — EQ 150MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 17, 2026