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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

OSIMERTINIB MESYLATE

ANDA

Tentative Approval

OSIMERTINIB MESYLATE | A214263 | ZYDUS PHARMS USA INC

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AstraZeneca AB et al v. Zydus Pharmaceuticals (USA), Inc. et al 1:2021cv00550 1 patentANDA 214263osimertinib mesylate	D. Del.	2021-04-16	Terminated 2021-11-15	—

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

API Supply Chain4 active DMFs

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

MSN LABORATORIES PRIVATE LTDOSIMERTINIB MESYLATE

DMF 321432017

ALEMBIC PHARMACEUTICALS LTDOSIMERTINIB MESYLATE

DMF 334092018

HETERO LABS LTDOSIMERTINIB MESYLATE

DMF 355812021

SCINOPHARM TAIWAN LTDOSIMERTINIB MESYLATE

DMF 365462021

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 8, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 40MG

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TABLET;ORAL | TA Date: 2021-06-01 00:00:00

No patent or exclusivity listings for this strength.

#002 — 80MG

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TABLET;ORAL | TA Date: 2021-06-01 00:00:00