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Formoterol fumarate - Generic Drug Details

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

This ingredient has sixty-three patent family members in twenty-eight countries.

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

Summary for Generic Name: formoterol fumarate

Tradenames:5
Patents:16
Applicants:4
NDAs:5
Drug Master File Entries: see list17
Suppliers / Packaging: see list3
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: formoterol fumarate

Tentative approvals for FORMOTEROL FUMARATE

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION;INHALATION20MCG/2ML
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pearl Theraps Inc
BEVESPI AEROSPHERE
formoterol fumarate; glycopyrrolate
AEROSOL, METERED;INHALATION208294-001Apr 25, 2016RXYes8,703,806► subscribe ► subscribe
Pearl Theraps Inc
BEVESPI AEROSPHERE
formoterol fumarate; glycopyrrolate
AEROSOL, METERED;INHALATION208294-001Apr 25, 2016RXYes8,324,266► subscribe ► subscribe
Novartis
FORADIL
formoterol fumarate
POWDER;INHALATION020831-001Feb 16, 2001RXYes6,887,459► subscribe ► subscribe
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Non-Orange Book Patents for Generic Ingredient: formoterol fumarate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,114,912Bronchodilating .beta.-agonist compositions and methods► subscribe
7,465,756Bronchodilating beta-agonist compositions and methods► subscribe
7,473,710Bronchodilating beta-agonist compositions and methods► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: formoterol fumarate

Country Document Number Estimated Expiration
Spain2554476► subscribe
World Intellectual Property Organization (WIPO)02083079► subscribe
Norway20021963► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FORMOTEROL FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
02C/022Belgium► subscribePRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825
C/GB02/033United Kingdom► subscribePRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
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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 verifification 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.

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