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AXITINIB

ANDA

AXITINIB | A211650 | APOTEX INC

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Apotex Inc. et al 1:2018cv00795 1 patentANDA 211650axitinib	D. Del.	2018-05-25	Terminated 2020-09-28	—

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

API Supply Chain7 active DMFs

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

MSN LABORATORIES PRIVATE LTDAXITINIB [ROUTE CODE - "XA"]

DMF 296722015

APOTEX INCAXITINIB

DMF 299182015

SHILPA PHARMA LIFESCIENCES LTDAXITINIB

DMF 301042015

MSN LABORATORIES PRIVATE LTDAXITINIB (FORM-XLI)[ROUTE CODE - "XB"]

DMF 303412016

SYNTHON BVAXITINIB

DMF 379712023

WISDOM PHARMACEUTICAL CO LTDAXITINIB

DMF 393232023

HETERO LABS LTDAXITINIB (FORM-XLI)

DMF 420162025

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 24, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 1MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 30, 2025

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 30, 2025