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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.

LUMATEPERONE TOSYLATE

ANDA

Tentative Approval

LUMATEPERONE TOSYLATE | A219248 | MSN LABORATORIES PRIVATE LTD

Hatch-Waxman Litigation

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
INTRA-CELLULAR THERAPIES, INC. v. MSN LABORATORIES PRIVATE LTD. 3:2024cv08854 10 patentsANDA 219248lumateperone	D.N.J.	2024-08-29	Active	—

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

API Supply Chain5 active DMFs

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

DR REDDYS LABORATORIES LTDLUMATEPERONE TOSYLATE

DMF 382062023

DASAMI LAB PRIVATE LTDLUMATEPERONE TOSYLATE

DMF 384072023

MAITHRI LABORATORIES PRIVATE LTDLUMATEPERONE TOSYLATE

DMF 387302023

ZYDUS LIFESCIENCES LTDLUMATEPERONE TOSYLATE

DMF 387782023

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDLUMATEPERONE TOSYLATE

DMF 426582025

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

Products (3)

Sort:

#001 — 10.5MG

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CAPSULE | TA Date: 2025-05-01 00:00:00

No patent or exclusivity listings for this strength.

#002 — 21MG

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CAPSULE | TA Date: 2025-05-01 00:00:00

#003 — 42MG

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CAPSULE | TA Date: 2025-05-01 00:00:00