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Last Updated: January 30, 2023

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 Pharms Ltd, Aucta, Lupin, Teva Pharms Usa Inc, Mylan Speclt, Astrazeneca, and Organon Llc, and is included in nine 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. Seven suppliers are listed for this compound.

Recent Clinical Trials for formoterol fumarate

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

SponsorPhase
Université de SherbrookeN/A
Cipla Ltd.Phase 3
PARZIBUT GillesPhase 4

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
Organon Llc DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-002 Jun 22, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Alembic Pharms Ltd FORMOTEROL FUMARATE formoterol fumarate SOLUTION;INHALATION 215078-001 Nov 22, 2021 AN RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon Llc DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-003 Aug 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon Llc DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-003 Aug 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 See Plans and Pricing See Plans and Pricing
Novartis FORADIL formoterol fumarate POWDER;INHALATION 020831-001 Feb 16, 2001 See Plans and Pricing See Plans and Pricing
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 See Plans and Pricing See Plans and Pricing
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 See Plans and Pricing See Plans and Pricing
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.