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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.

SIPONIMOD

ANDA

Tentative Approval

SIPONIMOD | A218228 | CIPLA LTD

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Novartis Pharmaceuticals Corporation et al v. Cipla Limited et al 1:2025cv00186 3 patentsANDA 218228siponimod	D. Del.	2025-02-14	Terminated 2025-10-06	—

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

API Supply Chain6 active DMFs

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

MAITHRI DRUGS PRIVATE LTDSIPONIMOD FUMARIC ACID

DMF 365962021

DR REDDYS LABORATORIES LTDSIPONIMOD HEMIFUMARATE

DMF 369272022

CIPLA LTDSIPONIMOD ADIPIC ACID

DMF 375202022

APITORIA PHARMA PRIVATE LTDSIPONIMOD FUMARIC ACID

DMF 376792022

SYNTHON BVSIPONIMOD ADIPIC ACID

DMF 410192025

SICHUAN KELUN PHARMACEUTICAL CO LTDSIPONIMOD

DMF 419502025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 24, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.25MG

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TABLET;ORAL | TA Date: 2025-01-10 00:00:00

No patent or exclusivity listings for this strength.

#002 — 1MG

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TABLET;ORAL | TA Date: 2025-01-10 00:00:00

#003 — 2MG

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TABLET;ORAL | TA Date: 2025-01-10 00:00:00