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CABOZANTINIB S-MALATE

ANDA

CABOZANTINIB S-MALATE | A213878 | MSN LABORATORIES PRIVATE LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CABOMETYX(TE code: AB)

Hatch-Waxman Litigation

3 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Exelixis, Inc. v. MSN Laboratories Private Limited et al 1:2025cv00346 1 patentANDA 213878cabozantinib	D. Del.	2025-03-19	Active	—
Exelixis, Inc. v. MSN Laboratories Private Limited et al 1:2022cv00945 7 patentsANDA 213878cabozantinib	D. Del.	2022-07-18	Terminated 2024-10-23	—
Exelixis, Inc. v. MSN Laboratories Private Limited et al 1:2019cv02017 1 patentANDA 213878cabozantinib	D. Del.	2019-10-29	Terminated 2023-01-30	—

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

API Supply Chain2 active DMFs

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

FERMION OYCABOZANTINIB S-MALATE

DMF 344372020

CHANGZHOU PHARMACEUTICAL FACTORYCABOZANTINIB

DMF 432952025

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

Products (3)

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#001 — EQ 20MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 14, 2026

No patent or exclusivity listings for this strength.

#002 — EQ 40MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 14, 2026

#003 — EQ 60MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 14, 2026