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NDA

FORMOTEROL FUMARATE | N020831 | NOVARTIS PHARMACEUTICALS CORP

1 strength0 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

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

7 trials from ClinicalTrials.gov — 3 recruiting, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation NCT07073950	Phase 4	Recruiting	AstraZeneca	56	2025-11-24 → 2027-05-31
A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease NCT06283966	Phase 3	Recruiting	AstraZeneca	5,250	2024-02-21 → 2027-12-03
Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma NCT07301736	Phase 2	Recruiting	Chiesi Farmaceutici S.p.A.	780	2025-12-17 → 2027-06-03
TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA NCT02676076	Phase 3	Completed	Chiesi Farmaceutici S.p.A.	1,155	2016-02-17 → 2018-05-17
Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF]NCT06511193	—	Completed	AstraZeneca	152	2024-09-17 → 2026-05-05
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)NCT04609878	Phase 3	Completed	AstraZeneca	2,274	2020-12-15 → 2025-03-21
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)NCT04609904	Phase 3	Completed	AstraZeneca	2,187	2021-03-01 → 2025-03-20

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain13 active DMFs4 inactive

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

INKE SAFORMOTEROL FUMARATE

DMF 166282003

MATRIX PHARMACORP PRIVATE LTDFORMOTEROL FUMARATE DIHYDRATE USP

DMF 192022006

CIPLA LTDFORMOTEROL FUMARATE USP

DMF 201782007

INDUSTRIALE CHIMICA SRLFORMOTEROL FUMARATE DIHYDRATE USP

DMF 201992007

TAPI NL BVFORMOTEROL FUMARATE DIHYDRATE

DMF 213572008

LUSOCHIMICA SPAFORMOTEROL FUMARATE DIHYDRATE

DMF 238482010

MSN LABORATORIES PRIVATE LTDFORMOTEROL FUMARATE USP [ROUTE CODE "FL"]

DMF 280112014

CORAL DRUGS PRIVATE LTDFORMOTEROL FUMARATE DIHYDRATE

DMF 303242016

FARMABIOS SPAFORMOTEROL FUMARATE

DMF 329362018

AMPHASTAR NANJING PHARMACEUTICALS INCFORMOTEROL FUMARATE USP

DMF 339132019

FERMION OYFORMOTEROL FUMARATE

DMF 338942019

MELODY HEALTHCARE PVT LTDFORMOTEROL FUMARATE

DMF 413172025

VAMSI LABS LTDFORMOTEROL FUMARATE DIHYDRATE USP

DMF 428102025

ASTELLAS PHARMA INCInactiveFORMOTEROL FUMARATE

DMF 123801997

INDUSTRIALE CHIMICA SRLInactiveFORMOTEROL FUMARATE DIHYDRATE MICRONIZED

DMF 141541999

SICOR SWISS BRANCHInactiveFORMOTEROL FUMARATE

DMF 162412002

VAMSI LABS LTDInactiveFORMOTEROL FUMARATE DIHYDRATE EP

DMF 404502024

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Apr 1, 2013	SUPPL -29	View Letter (PDF)
Apr 1, 2013	SUPPL -32	View Letter (PDF)
Oct 2, 2012	SUPPL -28	View Letter (PDF)
Mar 26, 2012	SUPPL -27	View Letter (PDF)
May 25, 2011	SUPPL -22	View Letter (PDF)
May 6, 2011	SUPPL -25	View Letter (PDF)
Feb 14, 2011	SUPPL -24	View Letter (PDF)
Jun 3, 2010	SUPPL -21	View Letter (PDF)
Jun 20, 2006	SUPPL -9	View Letter (PDF)
Jun 4, 2004	SUPPL -2	View Letter (PDF)
Jul 6, 2003	SUPPL -5	View Letter (PDF)
Feb 16, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

POWDER;INHALATION | Approved: Feb 16, 2001

No patent or exclusivity listings for this strength.