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Last Updated: October 16, 2019

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Formoterol fumarate - Generic Drug Details

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What are the generic drug sources for formoterol fumarate and what is the scope of patent protection?

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

Recent Clinical Trials for formoterol fumarate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Simbec ResearchPhase 1
AstraZenecaPhase 1
Mylan Inc.Phase 3

See all formoterol fumarate clinical trials

Recent Litigation for formoterol fumarate

Identify potential future generic entrants

District Court Litigation
Case NameDate
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. v. LUPIN ATLANTIS HOLDINGS SA2018-08-10
Dey LP v. Teva Parenteral Medicines Inc.2014-04-28
DEY, L. P. v. TEVA PARENTERAL MEDICINES, INC.2009-06-23

See all formoterol fumarate litigation

Generic filers with tentative approvals for FORMOTEROL FUMARATE
Applicant Application No. Strength Dosage Form
  See Pricing  See Pricing20MCG/2MLSOLUTION;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
(4-methoxyphenyl)propan-2-ylamino)
(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
(S,S)-formoterol fumarate
126587-85-7
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
43229-80-7
49861-99-6
67346-49-0
73573-87-2
73F872
814F304
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
AKOS015961179
AKOS015963255
AKOS015969668
AKOS024456605
AKOS025401373
AKOS027427027
AN-15811
AN-30485
AN-38345
API0009091
Arformoterol
Arformoterol (INN)
Arformoterol [INN]
arformoterol fumarate
Arformoterol tartrate
AS-11612
AS-14186
AT-16155
Atimos
Atock
Atock (TN)
B1359
BC205764
BC208644
BCP05216
BD 40A
BD-40A
BDBM50151720
BDBM86453
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
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
CHEMBL3989798
cid_9912089
CS-1326
CS-1413
D01373
D05277
D07463
D07990
DB00983
DB01274
DSSTox_CID_24239
DSSTox_GSID_44239
DSSTox_RID_80131
DTXSID5044239
eformoterol
ethyl)phenyl)formamide hemifumarate
F0881
F91H02EBWT
Fluir
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
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*))-
formoterol
Formoterol (Fumarate)
Formoterol (INN)
Formoterol [USAN:INN:BAN]
Formoterol fumarate (superceded)
Formoterol fumarate (superceded) [USAN]
Formoterol fumarate (USAN)
Formoterol fumarate [USAN:USP:JAN]
Formoterol fumarate [USAN]
Formoterol fumarate dihydrate
Formoterol fumarate hydrate (JP17)
Formoterol fumarate inhalation powder
Formoterol Fumarate,(S)
Formoterol Fumarate(Mixture of Diastereomers)
Formoterol fumerate dihydrate
Formoterol hemifumarate
Formoterol hemifumarate salt monohydrate
FORMOTEROLFUMARATE
Formoterolum
Formoterolum [INN-Latin]
GTPL3465
GTPL7479
H98
HMS3267L10
HMS3715P07
HSDB 7287
HY-B0010
HY-B0010A
Innovair
K252
KB-81521
KS-1174
L000259
LS-185081
MFCD11045919
MLS003115739
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-((S)-1-hydroxy-2-((S)-1-
N-(2-hydroxy-5-((S)-1-hydroxy-2-((S)-1-(4-methoxyphenyl)propan-2-ylamino)ethyl)phenyl)formamide hemifumarate
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)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-[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-(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
Oxeze Turbuhaler
Oxeze Turbuhaler Foradil
Oxeze/Oxis
Oxis
Oxis (TN)
Oxis pMDi
Performist
PT-005
Racemic formoterol
rel-N-(2-Hydroxy-5-((R)-1-hydroxy-2-(((R)-1-(4-methoxyphenyl)propan-2-yl)amino)ethyl)phenyl)formamide
SB17482
SC-94426
SCHEMBL15421797
SCHEMBL15856256
SCHEMBL1650339
SCHEMBL3040814
SCHEMBL349579
SCHEMBL3670606
SCHEMBL4247
SMR001831310
SR-01000872712
SR-01000872712-1
STL450992
SW199659-2
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 formoterol fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes   See Pricing   See Pricing   See Pricing
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Novartis FORADIL formoterol fumarate POWDER;INHALATION 020831-001 Feb 16, 2001 DISCN Yes No   See Pricing   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for formoterol fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis FORADIL formoterol fumarate POWDER;INHALATION 020831-001 Feb 16, 2001   See Pricing   See Pricing
Novartis FORADIL CERTIHALER formoterol fumarate POWDER;INHALATION 021592-001 Dec 15, 2006   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for formoterol fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435025 PA2019014 Lithuania   See Pricing PRODUCT NAME: GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) IR FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) DERINYS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
0613371 SPC/GB02/033 United Kingdom   See Pricing 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
2435025 122019000068 Germany   See Pricing PRODUCT NAME: KOMBINATION VON GLYCOPYRROLAT, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON, UND FORMOTEROL, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1339 20181218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Merck
Mallinckrodt
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Express Scripts

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