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Last Updated: November 2, 2024

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, Alembic, Lupin, Mankind Pharma, Micro Labs, Ritedose Corp, Teva Pharms Usa Inc, Wilshire Pharms Inc, Mylan Speclt, Astrazeneca, and Organon Llc, and is included in twelve NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for formoterol fumarate. Twelve suppliers are listed for this compound.

Drug Prices for FORMOTEROL FUMARATE

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Recent Clinical Trials for FORMOTEROL FUMARATE

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

SponsorPhase
Eurofarma Laboratorios S.A.Phase 3
SGS S.A.Phase 1
Université de SherbrookeN/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 Strength NDA ANDAs Submitted Submissiondate
PERFOROMIST Inhalation Solution formoterol fumarate 0.02 mg/2 mL 022007 1 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
Astrazeneca BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Wilshire Pharms Inc FORMOTEROL FUMARATE formoterol fumarate SOLUTION;INHALATION 215621-001 Dec 13, 2022 AN RX 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 FORMOTEROL FUMARATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis FORADIL CERTIHALER formoterol fumarate POWDER;INHALATION 021592-001 Dec 15, 2006 ⤷  Sign Up ⤷  Sign Up
Novartis FORADIL formoterol fumarate POWDER;INHALATION 020831-001 Feb 16, 2001 ⤷  Sign Up ⤷  Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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