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).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Tavalisse (2023)

Total Spending

$39.5M

Total Claims

2,895

Beneficiaries

486

Avg Cost/Unit

$236.40

Spending Trend

$17.8M(2019)→$21.7M(2020)→$25.3M(2021)→$32.4M(2022)→$39.5M(2023)

YoY Change:+7.6%

5yr CAGR:+7.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

2 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2025	SUPPL -3	View Letter (PDF)
Apr 17, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 100MG BASE

RLD

14 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 17, 2018

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE48898	Jan 19, 2026	—	—	Yes	—	—
7449458	Sep 4, 2031	—	Yes	—	—	—
7538108	Mar 28, 2026	—	Yes	—		—
7989448	Jun 12, 2026	—	Yes	—		—
8163902	Jun 17, 2026	—	Yes	—		—
8211889	Jan 19, 2026	—	Yes	—	—	—
8263122	Nov 24, 2030	—	—	Yes	—	—
8445485	Jun 17, 2026	—	—	Yes	—	—
8652492	Nov 6, 2028	—	—	Yes	—	—
8771648	Jul 27, 2032	—	—	Yes	—	—
8912170	Jun 17, 2026	—	—	—		—
8951504	Jul 27, 2032	—	—	—		—
9266912	Jan 19, 2026	—	—	—		—
9283238	Jun 17, 2026	—	—	—		—

#002 — EQ 150MG BASE

RLD

14 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 17, 2018