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 22^nd, 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:	4,044
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

Sponsor	Phase
University of Florida	Phase 1
Food and Drug Administration (FDA)	Phase 1
University of Tennessee Graduate School of Medicine	N/A

See all FORADIL clinical trials

US Patents and Regulatory Information for FORADIL

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	FORADIL CERTIHALER	formoterol fumarate	POWDER;INHALATION	021592-001	Dec 15, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	FORADIL	formoterol fumarate	POWDER;INHALATION	020831-001	Feb 16, 2001	⤷ Sign Up	⤷ Sign Up
Novartis	FORADIL	formoterol fumarate	POWDER;INHALATION	020831-001	Feb 16, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FORADIL

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

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Country	Patent Number	Title	Estimated Expiration
Japan	2013075909	AEROSOL COMPOSITION COMPRISING FORMOTEROL	⤷ Sign Up
Australia	3032399		⤷ Sign Up
Canada	2389349	UTILISATION DE COMPOSES ORGANIQUES DANS LE TRAITEMENT D'UNE MALADIE (AEROSOL COMPOSITION COMPRISING FORMOTEROL)	⤷ Sign Up
Brazil	0015908		⤷ Sign Up
Russian Federation	2327452	АЭРОЗОЛЬНАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ФОРМОТЕРОЛ (AEROSOL COMPOSITION CONTAINIG PHOMOTHEROL)	⤷ Sign Up
Germany	29923581		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FORADIL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0613371	2002C/022	Belgium	⤷ Sign Up	PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825
2435025	C201930043	Spain	⤷ Sign Up	PRODUCT NAME: UNA COMBINACION DE GLICOPIRROLATO (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES) Y FORMOTEROL (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES).; NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF AUTHORISATION: 20181218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1339; DATE OF FIRST AUTHORISATION IN EEA: 20181218
2435024	PA2021511	Lithuania	⤷ Sign Up	PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209
2435025	LUC00124	Luxembourg	⤷ Sign Up	PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435025	122019000068	Germany	⤷ Sign Up	PRODUCT NAME: KOMBINATION VON GLYCOPYRROLAT, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON, UND FORMOTEROL, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1339 20181218
2435024	2021C/518	Belgium	⤷ Sign Up	PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for FORADIL

Recent Clinical Trials for FORADIL

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