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Serving leading biopharmaceutical companies globally:

Julphar
Queensland Health
Daiichi Sankyo
Healthtrust
Colorcon
Covington
Johnson and Johnson
McKinsey
Baxter
Chinese Patent Office

Generated: November 22, 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 sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Formoterol fumarate has sixty-nine patent family members in twenty-eight countries and two supplementary protection certificates in two 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.

Pharmacology for formoterol fumarate

Medical Subject Heading (MeSH) Categories for formoterol fumarate

Tentative approvals for FORMOTEROL FUMARATE

Applicant Application No. Strength Dosage Form
u► 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
Astrazeneca Pharms
BEVESPI AEROSPHERE
formoterol fumarate; glycopyrrolate
AEROSOL, METERED;INHALATION208294-001Apr 25, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Pharms
BEVESPI AEROSPHERE
formoterol fumarate; glycopyrrolate
AEROSOL, METERED;INHALATION208294-001Apr 25, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Novartis
FORADIL
formoterol fumarate
POWDER;INHALATION020831-001Feb 16, 2001DISCNYesNo► Subscribe► Subscribe ► Subscribe
Novartis
FORADIL CERTIHALER
formoterol fumarate
POWDER;INHALATION021592-001Dec 15, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Speclt
PERFOROMIST
formoterol fumarate
SOLUTION;INHALATION022007-001May 11, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speclt
PERFOROMIST
formoterol fumarate
SOLUTION;INHALATION022007-001May 11, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-001Jun 22, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Pharms
BEVESPI AEROSPHERE
formoterol fumarate; glycopyrrolate
AEROSOL, METERED;INHALATION208294-001Apr 25, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: formoterol fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
FORADIL CERTIHALER
formoterol fumarate
POWDER;INHALATION021592-001Dec 15, 2006► 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
7,465,756Bronchodilating beta-agonist compositions and methods► Subscribe
8,114,912Bronchodilating .beta.-agonist compositions and methods► Subscribe
9,730,890Bronchodilating beta-agonist compositions and methods► Subscribe
7,541,385Bronchodilating .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
Colombia5080779► Subscribe
World Intellectual Property Organization (WIPO)02083079► Subscribe
Poland354974► Subscribe
Slovenia1381346► Subscribe
China1292715► Subscribe
Taiwan200507830► Subscribe
Hungary0203728► Subscribe
Canada2322575► Subscribe
China1212868► Subscribe
Australia3032399► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fuji
Express Scripts
McKesson
Deloitte
Cipla
Chubb
Healthtrust
Teva
Cerilliant
Novartis

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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