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NILOTINIB D-TARTRATE

NDA

NILOTINIB D-TARTRATE | N218922 | CIPLA LTD

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

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 1:2025cv00216 1 patentnilotinib d-tartrate	D. Del.	2025-02-21	Terminated 2025-03-11	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

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

CIPLA LTDNILOTINIB D-TARTRATE

DMF 367792022

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 11, 2025	SUPPL -1	View Letter (PDF)
Feb 21, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 50MG BASE

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Feb 19, 2025

No patent or exclusivity listings for this strength.

#002 — EQ 150MG BASE

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 19, 2025

#003 — EQ 200MG BASE

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 19, 2025