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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Julphar
Fuji
Daiichi Sankyo
Novartis
Moodys
Cantor Fitzgerald
Fish and Richardson
AstraZeneca
Colorcon

Generated: October 19, 2017

DrugPatentWatch Database Preview

Mylan Speclt Company Profile

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What is the competitive landscape for MYLAN SPECLT, and when can generic versions of MYLAN SPECLT drugs launch?

MYLAN SPECLT has two approved drugs.

There are five US patents protecting MYLAN SPECLT drugs.

There are thirteen patent family members on MYLAN SPECLT drugs in nine countries and two supplementary protection certificates in two countries.

Summary for Applicant: Mylan Speclt

International Patents:13
US Patents:5
Tradenames:2
Ingredients:2
NDAs:2
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speclt
PERFOROMIST
formoterol fumarate
SOLUTION;INHALATION022007-001May 11, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speclt
PERFOROMIST
formoterol fumarate
SOLUTION;INHALATION022007-001May 11, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speclt
PERFOROMIST
formoterol fumarate
SOLUTION;INHALATION022007-001May 11, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speclt
PERFOROMIST
formoterol fumarate
SOLUTION;INHALATION022007-001May 11, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speclt
ALBUTEROL SULFATE
albuterol sulfate
SOLUTION;INHALATION072652-001Feb 21, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Speclt
PERFOROMIST
formoterol fumarate
SOLUTION;INHALATION022007-001May 11, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
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Paragraph IV activity for MYLAN SPECLT drugs

Drugname Dosage Strength Tradename Submissiondate
formoterol fumarate
CapsulesInhalation Solution0.02 mg/2 mL
PERFOROMIST
1/21/2009

Non-Orange Book Patents for Mylan Speclt

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
9,730,890Bronchodilating beta-agonist compositions and methods► Subscribe
7,465,756Bronchodilating beta-agonist compositions and methods► Subscribe
7,541,385Bronchodilating .beta.-agonist compositions and methods► Subscribe
8,114,912Bronchodilating .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 Mylan Speclt Drugs

Country Document Number Estimated Expiration
European Patent Office1660035► Subscribe
Japan2013155208► Subscribe
TaiwanI359675► Subscribe
Slovenia1381346► Subscribe
World Intellectual Property Organization (WIPO)2005007142► Subscribe
European Patent Office1381346► Subscribe
Canada2438544► Subscribe
Japan2015178506► Subscribe
Spain2554476► Subscribe
Japan2004532217► 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 Mylan Speclt Drugs

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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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Deloitte
Baxter
QuintilesIMS
Chubb
Mallinckrodt
Harvard Business School
Teva
Cipla
Accenture
Merck

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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