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Last Updated: March 28, 2024

FORADIL Drug Patent Profile


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Which patents cover Foradil, and when can generic versions of Foradil launch?

Foradil is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in FORADIL is formoterol fumarate. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Foradil

A generic version of FORADIL was approved as formoterol fumarate by TEVA PHARMS USA INC on June 22nd, 2021.

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Summary for FORADIL
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 123
Clinical Trials: 33
Patent Applications: 4,063
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in FORADIL?FORADIL excipients list
DailyMed Link:FORADIL at DailyMed
Drug patent expirations by year for FORADIL
Recent Clinical Trials for FORADIL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of FloridaPhase 1
Food and Drug Administration (FDA)Phase 1
University of Tennessee Graduate School of MedicineN/A

See all FORADIL clinical trials

US Patents and Regulatory Information for FORADIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis FORADIL formoterol fumarate POWDER;INHALATION 020831-001 Feb 16, 2001 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis FORADIL CERTIHALER formoterol fumarate POWDER;INHALATION 021592-001 Dec 15, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for FORADIL

See the table below for patents covering FORADIL around the world.

Country Patent Number Title Estimated Expiration
Australia 2837401 ⤷  Try a Trial
Poland 342825 ⤷  Try a Trial
Japan 2013075909 AEROSOL COMPOSITION COMPRISING FORMOTEROL ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9945986 ⤷  Try a Trial
Russian Federation 2002116251 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FORADIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 2021019 Norway ⤷  Try a Trial PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216
2435024 21C1020 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024 C02435024/01 Switzerland ⤷  Try a Trial PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021
2435024 15/2021 Austria ⤷  Try a Trial PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
2435025 2019026 Norway ⤷  Try a Trial PRODUCT NAME: KOMBINASJON AV GLYKOPYRROLAT (INKLUDERT EVENTUELLE FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV) OG FORMOTEROL (INNBEFATTENDE HVILKE SOM HELST FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV); REG. NO/DATE: EU/1/18/1339 20190104
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.