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Harvard Business School
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Federal Trade Commission
Fuji
Medtronic
Johnson and Johnson

Generated: August 14, 2018

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FORMOTEROL FUMARATE - Generic Drug Details

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What are the generic sources for formoterol fumarate and what is the scope of formoterol fumarate freedom to operate?

Formoterol fumarate is the generic ingredient in five branded drugs marketed by Novartis, Mylan Speclt, Astrazeneca Pharms, and Merck Sharp Dohme, and is included in five NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Formoterol fumarate has sixty-nine patent family members in twenty-eight countries.

There are seventeen drug master file entries for formoterol fumarate. One supplier is listed for this compound. There is one tentative approval for this compound.

Pharmacology for FORMOTEROL FUMARATE
Medical Subject Heading (MeSH) Categories for FORMOTEROL FUMARATE
Synonyms for FORMOTEROL FUMARATE
(-)-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 (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
Tentative approvals for FORMOTEROL FUMARATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up20MCG/2MLSOLUTION;INHALATION

US Patents and Regulatory Information for FORMOTEROL FUMARATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-002 Jun 22, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FORADIL formoterol fumarate POWDER;INHALATION 020831-001 Feb 16, 2001 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 RX Yes Yes ➤ Sign Up ➤ 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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Non-Orange Book US Patents for FORMOTEROL FUMARATE

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
7,465,756 Bronchodilating beta-agonist compositions and methods ➤ Sign Up
7,473,710 Bronchodilating beta-agonist compositions and methods ➤ Sign Up
7,541,385 Bronchodilating .beta.-agonist compositions and methods ➤ Sign Up
8,114,912 Bronchodilating .beta.-agonist compositions and methods ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for FORMOTEROL FUMARATE

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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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Federal Trade Commission
McKesson
Johnson and Johnson
Moodys
McKinsey
Chubb
QuintilesIMS
US Department of Justice

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