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Serving 500+ biopharmaceutical companies globally:

Dow
Healthtrust
Argus Health
Citi
Deloitte
UBS
Accenture
Chubb
Baxter
Cipla

Generated: August 17, 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.

Summary for Applicant: Mylan Speclt

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
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
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
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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
7,465,756Bronchodilating beta-agonist compositions and methods► Subscribe
7,541,385Bronchodilating .beta.-agonist compositions and methods► Subscribe
7,473,710Bronchodilating beta-agonist compositions and methods► Subscribe
8,114,912Bronchodilating .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
Japan2013155208► Subscribe
Spain2554476► Subscribe
Australia2002244211► Subscribe
World Intellectual Property Organization (WIPO)2005007142► Subscribe
World Intellectual Property Organization (WIPO)02083079► 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
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
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
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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 500+ biopharmaceutical companies globally:

Citi
Deloitte
Merck
Julphar
Johnson and Johnson
US Army
QuintilesIMS
McKinsey
Fuji
Fish and Richardson

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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