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Last Updated: September 24, 2020

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FORADIL Drug 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. There is one patent protecting this drug.

This drug has twenty-eight patent family members in twenty-two countries.

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

US ANDA Litigation and Generic Entry Outlook for Foradil

Foradil was eligible for patent challenges on February 16, 2005.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 28, 2020. This may change due to patent challenges or generic licensing.

There is one tentative approval for the generic drug (formoterol fumarate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for FORADIL
International Patents:28
US Patents:1
Applicants:1
NDAs:2
Bulk Api Vendors: 83
Clinical Trials: 32
Formulation / Manufacturing:see details
DailyMed Link:FORADIL at DailyMed
Drug patent expirations by year for FORADIL
Generic Entry Opportunity Date for FORADIL
Generic Entry Date for FORADIL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FORADIL

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

SponsorPhase
University of FloridaPhase 1
Mylan Specialty L.P.N/A
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   Start Trial   Start Trial   Start Trial
Novartis FORADIL CERTIHALER formoterol fumarate POWDER;INHALATION 021592-001 Dec 15, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for FORADIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435025 36/2019 Austria   Start Trial PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
2435025 PA2019014 Lithuania   Start Trial PRODUCT NAME: GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) IR FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) DERINYS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
2435025 19C1040 France   Start 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 LUC00124 Luxembourg   Start Trial 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
>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.