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FORADIL

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from K&L Gates LLP FDA-2023-P-2536 · 4 docket documents K&L Gates LLP filed this petition on behalf of an unnamed client requesting that the FDA determine whether FORADIL (Formoterol fumarate) Inhalation Powder, 0.012 mg/inh approved under NDA N020831 was withdrawn for safety or effectiveness reasons under Section 505(w) of the FDC Act and 21 C.F.R. § 31	505(q)	2023-06-22	Granted	K&L Gates LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

310 trials from ClinicalTrials.gov — 1 recruiting, 259 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma NCT01225913	Phase 4	Recruiting	Gelb, Arthur F., M.D.	50	2007-10 → 2027-06
A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD NCT00308191	Phase 3	Completed	Dey	128	2006-04 → 2006-12
Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence NCT02045875	Phase 4	Completed	Asthma Management Systems	50	2014-03-04 → 2017-07-12
Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Participants With Asthma NCT02062463	Phase 3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	485	2014-05-28 → 2015-03-13
The Effect of BEVESPI AEROSPHERE ® Therapy on Exercise Tolerance in COPD NCT03081156	Phase 4	Completed	William Stringer, md	52	2017-03-27 → 2019-01-31
Study in Patients With Asthma NCT00215358	Phase 2	Completed	Dey	32	2002-07 → 2005-12
Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)NCT00383240	Phase 3	Completed	Organon and Co	781	2006-09 → 2008-09
Symbicort in Asthmatic Children - SEEDLING NCT00651547	Phase 3	Completed	AstraZeneca	405	2002-07 → 2003-10
Study of Arformoterol Tartrate Inhalation Solution and Racemic Formoterol in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)NCT00685529	Phase 2	Completed	Sumitomo Pharma America, Inc.	24	2005-04 → 2005-10
Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects NCT00691951	Phase 3	Completed	Laval University	—	—

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

FERMION OYFORMOTEROL FUMARATE

DMF 338942019

AMPHASTAR NANJING PHARMACEUTICALS INCFORMOTEROL FUMARATE USP

DMF 339132019

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.