FORADIL CERTIHALER Drug Patent Profile

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. Thirteen 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.

Summary for FORADIL CERTIHALER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	36
Patent Applications:	1,107
DailyMed Link:	FORADIL CERTIHALER at DailyMed

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

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
Novartis	FORADIL CERTIHALER	formoterol fumarate	POWDER;INHALATION	021592-001	Dec 15, 2006

International Patents for FORADIL CERTIHALER

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0865302
Czech Republic	303154	Suchá prášková formulace k inhalaci obsahující stearát horecnatý (Dry powder formulation for inhalation containing magnesium stearate)
Russian Federation	2221552	СУХОЙ ПОРОШОК ДЛЯ ИНГАЛЯЦИИ (DRY INHALATION POWDER)
European Patent Office	1862164
Austria	382386

Supplementary Protection Certificates for FORADIL CERTIHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	C201930043	Spain		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	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
2435024	C02435024/01	Switzerland		PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021
2435024	PA2021511,C2435024	Lithuania		PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209
2435024	301102	Netherlands		PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210