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Last Updated: March 28, 2024

FORADIL CERTIHALER Drug Patent Profile


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When do Foradil Certihaler patents expire, and what generic alternatives are available?

Foradil Certihaler is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in FORADIL CERTIHALER 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 Certihaler

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

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US Patents and Regulatory Information for FORADIL CERTIHALER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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

Expired US Patents for FORADIL CERTIHALER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis FORADIL CERTIHALER formoterol fumarate POWDER;INHALATION 021592-001 Dec 15, 2006 ⤷  Try a Trial ⤷  Try a Trial
Novartis FORADIL CERTIHALER formoterol fumarate POWDER;INHALATION 021592-001 Dec 15, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FORADIL CERTIHALER

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

Country Patent Number Title Estimated Expiration
Australia 6457899 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9720589 ⤷  Try a Trial
Spain 2298323 ⤷  Try a Trial
Austria 233550 ⤷  Try a Trial
Japan 2000501013 ⤷  Try a Trial
Slovakia 6322001 DRY POWDER FOR INHALATION ⤷  Try a Trial
Japan 2016147899 吸入用の乾燥粉末 (DRY POWDER FOR INHALATION) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FORADIL CERTIHALER

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
2435025 2019C/532 Belgium ⤷  Try a Trial PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435024 CA 2021 00014 Denmark ⤷  Try a Trial PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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