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 22^nd, 2021.

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Summary for FORADIL CERTIHALER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	36
Patent Applications:	1,244
Formulation / Manufacturing:	see details
DailyMed Link:	FORADIL CERTIHALER at DailyMed

Drug patent expirations by year for FORADIL CERTIHALER

Anatomical Therapeutic Chemical (ATC) Classes for FORADIL CERTIHALER

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03CC	Selective beta-2-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for FORADIL CERTIHALER

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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 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

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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.

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Country	Patent Number	Title	Estimated Expiration
New Zealand	511527	Dry powder for inhalation	⤷ Try a Trial
Denmark	0995457		⤷ Try a Trial
Germany	59605366		⤷ Try a Trial
Canada	2239292	INHALATEUR FOURNISSANT DES DOSES MULTIPLES D'UNE POUDRE SECHE PHARMACOLOGIQUE (INHALATOR DESIGNED TO PROVIDE MULTIPLE DOSES OF A DRY PHARMACOLOGICAL POWDER)	⤷ Try a Trial
Spain	2216418		⤷ Try a Trial
Australia	756852		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FORADIL CERTIHALER

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	19C1040	France	⤷ Try a Trial	PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220
2435025	36/2019	Austria	⤷ Try a Trial	PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
2435025	122019000068	Germany	⤷ Try a Trial	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
2435025	PA2019014,C2435025	Lithuania	⤷ Try a Trial	PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
2435024	PA2021511	Lithuania	⤷ Try a Trial	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
2435024	SPC/GB21/029	United Kingdom	⤷ Try a Trial	PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Summary for FORADIL CERTIHALER

Anatomical Therapeutic Chemical (ATC) Classes for FORADIL CERTIHALER

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