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Generated: May 30, 2017

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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 formoterol fumarate patent protection?

Formoterol fumarate
is the generic ingredient in five branded drugs marketed by Mylan Speclt, Novartis, Astrazeneca Pharms, and Merck Sharp Dohme, and is included in five NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Formoterol fumarate has sixty-five patent family members in twenty-eight countries.

There are seventeen drug master file entries for formoterol fumarate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: formoterol fumarate

Drug Master File Entries: see list17
Suppliers / Packagers: see list2
Bulk Api Vendors: see list126
Clinical Trials: see list306
Patent Applications: see list10,348
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:formoterol fumarate at DailyMed

Pharmacology for Ingredient: formoterol fumarate

Tentative approvals for FORMOTEROL FUMARATE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe20MCG/2MLSOLUTION;INHALATION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 2010RXYesYes6,068,832► SubscribeY ► Subscribe
formoterol fumarate
POWDER;INHALATION021592-001Dec 15, 2006DISCNNoNo► Subscribe► Subscribe
Mylan Speclt
formoterol fumarate
SOLUTION;INHALATION022007-001May 11, 2007RXYesYes8,623,922► SubscribeY ► Subscribe
Astrazeneca Pharms
formoterol fumarate; glycopyrrolate
AEROSOL, METERED;INHALATION208294-001Apr 25, 2016RXYesYes► Subscribe► Subscribe
formoterol fumarate
POWDER;INHALATION020831-001Feb 16, 2001DISCNYesNo6,488,027► Subscribe ► Subscribe
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