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ARCAPTA NEOHALER

NDA

INDACATEROL MALEATE | N022383 | NOVARTIS PHARMACEUTICALS CORP

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

Oct. 11, 2028

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs

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

NEULAND LABORATORIES LTDINDACATEROL MALEATE

DMF 342942019

INKE SAINDACATEROL MALEATE (MICRONIZED AND NON-MICRONIZED)

DMF 344112024

MELODY HEALTHCARE PVT LTDINDACATEROL MALEATE IH

DMF 380002023

BREATHGREEN PHARMACEUTICAL CO LTDINDACATEROL MALEATE(MICRONIZED AND NON-MICRONIZED)

DMF 397652024

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

Approval Letters

7 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 75MCG BASE

RLD

1 patent0 exclusivities▴

POWDER;INHALATION | Approved: Jul 1, 2011

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8479730	Oct 11, 2028	—	—	Yes	—	—