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PERFOROMIST Drug Profile

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Which patents cover Perforomist, and what generic alternatives are available?

Perforomist is a drug marketed by Mylan Speclt and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in nine countries.

The generic ingredient in PERFOROMIST is formoterol fumarate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate profile page.

Summary for PERFOROMIST

International Patents:	16
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	3
Clinical Trials:	5
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PERFOROMIST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PERFOROMIST
Prior Art and Litigation Support	Order Prior Art and Litigation support for PERFOROMIST
DailyMed Link:	PERFOROMIST at DailyMed

Pharmacology for PERFOROMIST

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

Medical Subject Heading (MeSH) Categories for PERFOROMIST

Adrenergic beta-2 Receptor Agonists

Bronchodilator Agents

Synonyms for PERFOROMIST

(E)-but-2-enedioic acid; N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(2R)-1-(4-methoxyphenyl)propan-2-yl]amino]ethyl]phenyl]formamide; hydrate

AC1OCEVQ

Atimos

Atock

BD-40A

Broncoral

CGP-25827A

Eformoterol fumarate

Eolus

Foradil Aerolizer

Foradil Certihaler

Formoterol Easyhaler

FORMOTEROL FUMARATE

Oxeze Turbuhaler

Oxis Turbuhaler

PT-005

YM-08316

US Patents and Regulatory Information for PERFOROMIST

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			Y
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007		RX	Yes	Yes			Y
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007		RX	Yes	Yes			Y
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007		RX	Yes	Yes			Y
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007		RX	Yes	Yes			Y

Paragraph IV (Patent) Challenges for PERFOROMIST

Drugname	Dosage	Strength	RLD	Date
	CapsulesInhalation Solution	0.02 mg/2 mL

International Patents for PERFOROMIST

Country	Patent Number	Estimated Expiration
Japan	2009046490
Taiwan	200507830
Australia	2002244211
Japan	2004532217
Japan	2013155208

Supplementary Protection Certificates for PERFOROMIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0613371	SPC/GB02/033	United Kingdom		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
0613371	2002C/022	Belgium		PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825