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Last Updated: August 9, 2022

Formoterol fumarate - Generic Drug Details


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What are the generic 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, Teva Pharms Usa Inc, Mylan Speclt, Astrazeneca, and Organon, and is included in seven 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. Five suppliers are listed for this compound.

Recent Clinical Trials for formoterol fumarate

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SponsorPhase
Cipla Ltd.Phase 3
PARZIBUT GillesPhase 4
ShiYue LiN/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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-001 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 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 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
Novartis FORADIL CERTIHALER formoterol fumarate POWDER;INHALATION 021592-001 Dec 15, 2006 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
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Express Scripts
AstraZeneca
Moodys

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