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Last Updated: October 26, 2021

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Formoterol fumarate - Generic Drug Details

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What are the generic drug sources for formoterol fumarate and what is the scope of patent protection?

Formoterol fumarate is the generic ingredient in six branded drugs marketed by Novartis, Teva Pharms Usa Inc, Mylan Speclt, Astrazeneca, and Organon, and is included in six NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Formoterol fumarate has sixteen patent family members in nine countries.

There are nineteen drug master file entries for formoterol fumarate. Four suppliers are listed for this compound.

Recent Clinical Trials for formoterol fumarate

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

SponsorPhase
PARZIBUT GillesPhase 4
ShiYue LiN/A
AstraZenecaN/A

See all formoterol fumarate clinical trials

Pharmacology for formoterol fumarate
Medical Subject Heading (MeSH) Categories for formoterol fumarate
Paragraph IV (Patent) Challenges for FORMOTEROL FUMARATE
Tradename Dosage Ingredient NDA Submissiondate
PERFOROMIST SOLUTION;INHALATION formoterol fumarate 022007 2009-01-21

US Patents and Regulatory Information for formoterol fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-002 Jun 22, 2010 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Organon DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-003 Aug 12, 2019 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis FORADIL CERTIHALER formoterol fumarate POWDER;INHALATION 021592-001 Dec 15, 2006 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 AN RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Astrazeneca BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 formoterol fumarate

Supplementary Protection Certificates for formoterol fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 15/2021 Austria ⤷  Free Forever Trial PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
2435025 19C1040 France ⤷  Free Forever 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 CR 2019 00032 Denmark ⤷  Free Forever Trial PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER SOLVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
2435024 301102 Netherlands ⤷  Free Forever Trial 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
0613371 2002C/022 Belgium ⤷  Free Forever Trial PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825
2435024 CA 2021 00014 Denmark ⤷  Free Forever 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
2435025 122019000068 Germany ⤷  Free Forever 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Boehringer Ingelheim
Harvard Business School
AstraZeneca
Dow

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