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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 seventeen 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:	139
Clinical Trials:	4
Patent Applications:	3,974
Formulation / Manufacturing:	see details
Drug Prices:	see details
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

(-)-Formoterol

(-)-Formoterol;Arformoterol;(R,R)-Formoterol

(+-)-2'-Hydroxy-5'-((R*)-1-hydroxy-2-(((R*)-p-methoxy-alpha-methylphenethyl)amino)ethyl)formanilide fumarate (2:1) (salt)

(+-)-2'-Hydroxy-5'-((RS)-1-hydroxy-2-(((RS)-p-methoxy-alpha-methylphenethyl)amino)ethyl)formanilide

(+-)-Formoterol

(+/-)-(R,R)-N-[2-Hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl] formamide hemifumarate

(C19H24N2O4)2.C4H4O4

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

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

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

(R,R)-Formoterol

(R,R)-formoterol fumarate

(R*,R*)-(+)-N-[2-HYDROXY-5-[1-HYDROXY-2-[[2-(4-METHOXYPHENYL)-1-METHYLETHYL]AMINO]ETHYL]-PHENYL]FORMAMIDE FUMARATE

(R*,R*)-N-[2-HYDROXY-5-[1-HYDROXY-2-[[2-(4-METHOXYPHENYL)-1-METHYLETHYL]AMINO]ETHYL]PHENYL]FORMAMIDE FUMARATE (2:1) SALT

(S,S)-formoterol fumarate

126587-85-7

128954-45-0

169375-55-7

183814-29-1

183814-30-4

2'-hydroxy-5'-(1-hydroxy-2-((p-methoxy-alpha-methylphenethyl)amino)ethyl)formanilide

2'-hydroxy-5'-{1-hydroxy-2-[(p-methoxy-alpha-methylphenethyl)amino]ethyl}formanilide

208102-40-3

229F807

289657-27-8

299964-45-7

3-formylamino-4-hydroxy-alpha-(N-1-methyl-2-p-methoxyphenethylaminomethyl)benzyl alcohol.hemifumarate

43229-80-7

49861-99-6

67346-49-0

73573-87-2

73F872

83536-10-1

87481-49-0

87833-61-2

AB0014121

AB0072702

AB13267

AB2000426

AC-1322

AC-19951

AC-459

AC1L1FVE

AC1MJ0T4

AC1NR014

AC1O5MY8

AC1Q6QRX

ACT03309

aformoterol

AJ-44036

AK116451

AK144665

AK481291

AKOS015961179

AKOS015963255

AKOS015969668

AKOS024456605

AKOS025401373

AKOS027427027

Ambap43229-80-7

AN-15811

AN-30485

AN-38345

API0009091

Arformoterol

Arformoterol (INN)

Arformoterol [INN]

arformoterol fumarate

Arformoterol tartrate

AS-11612

AS-14186

Atimos

Atimos (TN)

Atock

Atock (TN)

B1359

BC205764

BC208644

BD 40A

BD-40A

BDBM50151720

BDBM86453

BIS(FORMOTEROL); FUMARIC ACID

bis(N-{2-hydroxy-5-[(1S)-1-hydroxy-2-{[(2S)-1-(4-methoxyphenyl)propan-2-yl]amino}ethyl]phenyl}formamide); fumaric acid

bis[(2R)-N-{(2R)-2-[3-(formylamino)-4-hydroxyphenyl]-2-hydroxyethyl}-1-(4-methoxyphenyl)propan-2-aminium] (2E)-but-2-enedioate

bis[(2S)-N-{(2S)-2-[3-(formylamino)-4-hydroxyphenyl]-2-hydroxyethyl}-1-(4-methoxyphenyl)propan-2-aminium] (2E)-but-2-enedioate

BPZSYCZIITTYBL-UHFFFAOYSA-N

BPZSYCZIITTYBL-YJYMSZOUSA-N

Brovana

Brovana (TN)

but-2-enedioic acid; N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methyl-ethyl]amino]ethyl]phenyl]formamide; dihydrate

C07805

CAS_73573-87-2

CAS-43229-80-7

CCG-221193

CGP 25827A

CGP-25827A

CHEBI:408174

CHEBI:63082

CHEBI:63108

CHEBI:63109

CHEMBL1256786

CHEMBL1363

CHEMBL1893395

CHEMBL3184383

cid_9912089

CS-1326

CS-1413

D01373

D04KJO

D07463

D07990

D0D1DI

D0E5FY

D0P2AG

DB00983

DB01274

DSSTox_CID_24239

DSSTox_GSID_44239

DSSTox_RID_80131

DTXSID5044239

eformoterol

F0881

F91H02EBWT

Fluir

Flutiform (TN)

Foradil

Foradil (TN)

Foradil acrolizer

Foradil Aerolizer

Foradil Certihaler

Foradil/Foradile (Schering-Plough in the U.S., Novartis rest of world), Oxeze/Oxis (AstraZeneca), Atock (Astellas), Atimos/Atimos Modulite (Chiesi), and Perforomist (Dey)

Foradile

Foradile (TN)

FORMAMIDE N-[2-HYDROXY-5-[(1R)-1-HYDROXY-2-[[(1R)-2-(4-METHOXYPHENYL)-1-METHYLETHYL]AMINO]ETHYL]PHENYL]- REL-

Formamide, N-(2-hydroxy-5-((1R)-1-hydroxy-2-(((1R)-2-(4-methoxyphenyl)-1-methylethyl)amino)ethyl)phenyl)-

Formamide, N-(2-hydroxy-5-((1R)-1-hydroxy-2-(((1R)-2-(4-methoxyphenyl)-1-methylethyl)amino)ethyl)phenyl)-, rel-, (2E)-2-butenedioate (2:1) (salt), dihydrate

Formamide, N-(2-hydroxy-5-((1R)-1-hydroxy-2-(((1R)-2-(4-methoxyphenyl)-1-methylethyl)amino)ethyl)phenyl)-, rel-, (E)-2-butenedioate (2:1) (salt)

Formamide, N-(2-hydroxy-5-(1-hydroxy-2-((2-(4-methoxyphenyl)-1-methylethyl)amino)ethyl)phenyl)-, (R-(R*,R*))-

FORMAMIDE,N-[2-HYDROXY-5-[1-HYDROXY-2-[[2-(4-METHOXYPHENYL)-ISOPROPYL]AMINO]ETHYL]PHENYL]-,[R-(R*,S*)]-

formoterol

Formoterol (Fumarate)

Formoterol (INN)

Formoterol (mixture of Diastereomers)

Formoterol [USAN:INN:BAN]

FORMOTEROL FUMARATE

Formoterol Fumarate (Mixture of Diastereomers)

Formoterol fumarate (superceded)

Formoterol fumarate (superceded) [USAN]

Formoterol fumarate (USAN)

Formoterol fumarate [USAN:USP:JAN]

Formoterol fumarate [USAN]

Formoterol fumarate dihydrate

Formoterol fumarate inhalation powder

Formoterol Fumarate(Mixture of Diastereomers)

Formoterol fumerate dihydrate

Formoterol hemifumarate

FORMOTEROL HEMIFUMARATE; ()-(R*,R*)-N-[2-HYDROXY-5-[1-HYDROXY-2-[[2-(4-METHOXYPH ENYL)-1-METHYLETHYL]AMINO]ETHYL]PHENYL] FORMAMIDE HEMIFUMARATE

Formoterol tartrate

Formoterol, ((R*,R*)-(+-)-)-isomer

Formoterol/budesonide

Formoterol/fluticasone propionate

FORMOTEROLFUMARATE

Formoterolum

Formoterolum [INN-Latin]

GTPL3465

GTPL7479

HMS3267L10

HSDB 7287

HY-B0010

HY-B0010A

Innovair

K252

KB-81521

KS-1174

L000259

LS-185081

MFCD05662345

MFCD11045919

MLS003115739

Modulite (TN)

MOLI000351

MolPort-003-847-486

MolPort-003-983-476

MolPort-005-934-219

MolPort-038-387-072

N-(2-Hydroxy-5-((R)-1-hydroxy-2-(((R)-1-(4-methoxyphenyl)propan-2-yl)amino)ethyl)phenyl)formamide

N-(2-hydroxy-5-((R)-1-hydroxy-2-(((R)-1-(4-methoxyphenyl)propan-2-yl)amino)ethyl)phenyl)formamide hemifumarate

N-(2-hydroxy-5-((R)-1-hydroxy-2-((R)-1-(4-methoxyphenyl)propan-2-ylamino)ethyl)phenyl)formamide

N-(2-hydroxy-5-((S)-1-hydroxy-2-(((S)-1-(4-methoxyphenyl)propan-2-yl)amino)ethyl)phenyl)formamide hemifumarate

N-(2-Hydroxy-5-(1-hydroxy-2-((1-(4-methoxyphenyl)propan-2-yl)amino)ethyl)phenyl)formamide

N-(2-Hydroxy-5-(1-hydroxy-2-((2-(4-methoxyphenyl)-1-methylethyl)amino)ethyl)phenyl)formamide, (E)-2-butenedioate (2:1) (salt)

N-(2-Hydroxy-5-{1-hydroxy-2-[2-(4-methoxy-phenyl)-1-methyl-ethylamino]-ethyl}-phenyl)-formamide

N-[2-Hydroxy-5-(1-hydroxy-2-{[1-(4-methoxyphenyl)-2-propanyl

n-[2-hydroxy-5-(1-hydroxy-2-{[1-(4-methoxyphenyl)propan-2-yl]amino}ethyl)phenyl]formamide

N-[2-hydroxy-5-(1-hydroxy-2-{[2-(4-methoxyphenyl)-1-methylethyl]amino}ethyl)phenyl]formamide

N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methyl-ethyl]amino]ethyl]phenyl]formamide

N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(2R)-1-(4-methoxyphenyl)propan-2-yl]amino]ethyl]phenyl]formamide

N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(2S)-1-(4-methoxyphenyl)propan-2-yl]amino]ethyl]phenyl]formamide

N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methyl-ethyl]amino]ethyl]phenyl]formamide

N-[2-Hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-formamide (2E)-2-Butenedioate Salt

N-[2-Hydroxy-5-[1-hydroxy-2-[1- propan-2-ylamino]ethyl]phenyl]formamide

N-[2-hydroxy-5-[1-hydroxy-2-[1-(4-methoxyphenyl)propan-2-ylamino]ethyl]phenyl]formamide

N-{2-hydroxy-5-[(1R)-1-hydroxy-2-({(1R)-1-methyl-2-[4-(methyloxy)phenyl]ethyl}amino)ethyl]phenyl}formamide

N-{2-hydroxy-5-[(1R)-1-hydroxy-2-{[(2R)-1-(4-methoxyphenyl)propan-2-yl]amino}ethyl]phenyl}formamide

N-{2-hydroxy-5-[(1R)-1-hydroxy-2-{[(2R)-1-(4-methoxyphenyl)propan-2-yl]amino}ethyl]phenyl}formamide (2E)-but-2-enedioate

N-{2-hydroxy-5-[(1S)-1-hydroxy-2-{[(2S)-1-(4-methoxyphenyl)propan-2-yl]amino}ethyl]phenyl}formamide (2E)-but-2-enedioate

NCGC00181126-01

NSC 299587

NSC_3083544

NSC-299587

NSC299587

OR034485

OR069107

OR069108

OR234180

OR324944

OR324945

OR334953

OR356494

Oxeze (TN)

Oxeze Turbuhaler

Oxeze Turbuhaler Foradil

Oxeze/Oxis

Oxis

Oxis (TN)

Oxis pMDi

Performist

Perforomist (TN)

Propanoic acid, 3-[[[4-[4-[[[1-(2-chlorophenyl)ethoxy]carbonyl]amino]-3-methyl-5-isoxazolyl]phenyl]methyl]thio]-, methyl ester

PT-005

Racemic formoterol

rel-N-(2-Hydroxy-5-((R)-1-hydroxy-2-(((R)-1-(4-methoxyphenyl)propan-2-yl)amino)ethyl)phenyl)formamide

SC-94426

SCHEMBL15421797

SCHEMBL15856256

SCHEMBL1650339

SCHEMBL3040814

SCHEMBL349579

SCHEMBL3670606

SCHEMBL4247

SMR001831310

STL450992

Symbicort (TN)

Tox21_112734

UNII-5ZZ84GCW8B component BPZSYCZIITTYBL-YJYMSZOUSA-N

UNII-F91H02EBWT

UNII-P3T5QA5J9N component OBRNDARFFFHCGE-PERKLWIXSA-N

UNII-P3T5QA5J9N component OBRNDARFFFHCGE-QDSVTUBZSA-N

UNII-W34SHF8J2K component RATSWNOMCHFQGJ-AYJOUMQSSA-N

VA10968

W-5127

W-5296

X5000

YM 08316

YM-08316

ZINC2599970

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

Paragraph IV (Patent) Challenges for PERFOROMIST

Drugname	Dosage	Strength	RLD	Submissiondate
	CapsulesInhalation Solution	0.02 mg/2 mL		2009-01-21

Non-Orange Book US Patents for PERFOROMIST

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
7,541,385	Bronchodilating .beta.-agonist compositions and methods
8,114,912	Bronchodilating .beta.-agonist compositions and methods
7,465,756	Bronchodilating beta-agonist compositions and methods
7,473,710	Bronchodilating beta-agonist compositions and methods

International Patents for PERFOROMIST

Country	Document Number	Estimated Expiration
Japan	2013155208
World Intellectual Property Organization (WIPO)	02083079
Australia	2002244211
Japan	6214925

Supplementary Protection Certificates for PERFOROMIST

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/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
02C/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