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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Teva
Fuji
Citi
Farmers Insurance
Cerilliant
Argus Health
Colorcon
Daiichi Sankyo

Generated: October 21, 2018

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Mylan Speclt Company Profile

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What is the competitive landscape for MYLAN SPECLT, and what generic alternatives to MYLAN SPECLT drugs are available?

MYLAN SPECLT has two approved drugs.

There are six US patents protecting MYLAN SPECLT drugs.

Summary for Mylan Speclt
US Patents:6
Tradenames:2
Ingredients:2
NDAs:2

Drugs and US Patents for Mylan Speclt

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;INHALATION 022007-001 May 11, 2007 RX Yes Yes 7,462,645 ➤ Sign Up Y ➤ Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 RX Yes Yes 6,814,953 ➤ Sign Up Y ➤ Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 RX Yes Yes 8,623,922 ➤ Sign Up Y ➤ Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 RX Yes Yes 7,348,362 ➤ Sign Up Y ➤ Sign Up
Mylan Speclt ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 072652-001 Feb 21, 1992 DISCN No No ➤ Sign Up ➤ Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 RX Yes Yes 9,730,890 ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for MYLAN SPECLT drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe CapsulesInhalation Solution 0.02 mg/2 mL ➤ Subscribe 2009-01-21

Supplementary Protection Certificates for Mylan Speclt Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
02C/022 Belgium ➤ Sign Up PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825
C/GB02/033 United Kingdom ➤ Sign Up PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Baxter
Harvard Business School
US Army
Julphar
Fuji
QuintilesIMS
Dow
Teva

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