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Last Updated: October 18, 2019

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ACLIDINIUM BROMIDE - Generic Drug Details

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What are the generic drug sources for aclidinium bromide and what is the scope of freedom to operate?

Aclidinium bromide is the generic ingredient in two branded drugs marketed by Circassia and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aclidinium bromide has one hundred and thirty-one patent family members in forty-three countries.

There is one drug master file entry for aclidinium bromide. Two suppliers are listed for this compound.

Summary for ACLIDINIUM BROMIDE
International Patents:131
US Patents:10
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 1
Suppliers / Packagers: 2
Bulk Api Vendors: 40
Clinical Trials: 39
Patent Applications: 130
DailyMed Link:ACLIDINIUM BROMIDE at DailyMed
Recent Clinical Trials for ACLIDINIUM BROMIDE

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

SponsorPhase
AstraZenecaPhase 1
Center for Integrated Rehabilitation and Organ Failure HornPhase 4
Maastricht University Medical CenterPhase 4

See all ACLIDINIUM BROMIDE clinical trials

Pharmacology for ACLIDINIUM BROMIDE
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Synonyms for ACLIDINIUM BROMIDE
(3R)-3-((Hydroxydi(thiophen-2-yl)acetyl)oxy)-1-(3-phenoxypropyl)-1-azoniabicyclo(2.2.2)octane bromide
(3R)-3-(2-Hydroxy-2,2-di(thiophen-2-yl)acetoxy)-1-(3-phenoxypropyl)quinuclidin-1-ium bromide
(3R)-3-[2-hydroxy(di-2-thienyl)acetoxy]-1-(3-phenoxypropyl)-1-azoniabicyclo[2.2.2]octane bromide
(3R)-3-{[Hydroxy(di-2-thienyl)acetyl]oxy}-1-(3-phenoxypropyl)-1-azoniabicyclo[2.2.2]octane bromide
(R)-3-(2-hydroxy-2,2-di(thiophen-2-yl)acetoxy)-1-(3-phenoxypropyl)quinuclidin-1-ium bromide
1-Azoniabicyclo(2.2.2)octane, 3-((hydroxydi-2-thienylacetyl)oxy)-1-(3-phenoxypropyl)-, bromide, (3R)-
2195AH
3(R)-(2-hydroxy-2,2-dithien-2-ylacetoxy)-1-(3-phenoxypropyl)-1-azoniabicyclo[2.2.2]octane bromide
320345-99-1
AC-23963
Aclidinium (Bromide)
Aclidinium bromide (JAN/USAN/INN)
Aclidinium bromide [USAN:INN]
AKOS016010522
Bretaris
C26H30NO4S2.Br
CHEBI:65344
CHEMBL551466
CS-0896
D08837
DTXSID30185854
Eklira
Eklira genuair (TN)
FT-0649851
Genuair
HY-14144
J-018606
KRP-AB1102
KS-0000104H
LAS 34273
LAS W-330
LAS-34273
LAS-34273 Micronized
LAS-W-330
MolPort-027-836-029
MolPort-035-395-763
s4031
SB16809
SCHEMBL72694
SW219176-1
Tudorza Pressair
Tudorza pressair (TN)
UNII-UQW7UF9N91
UQW7UF9N91
W-5426
XLAKJQPTOJHYDR-QTQXQZBYSA-M

US Patents and Regulatory Information for ACLIDINIUM BROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX No No   Start Trial   Start Trial Y   Start Trial
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX No No   Start Trial   Start Trial Y Y   Start Trial
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX No No   Start Trial   Start Trial Y   Start Trial
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX No No   Start Trial   Start Trial Y   Start Trial
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX No No   Start Trial   Start Trial Y   Start Trial
>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 ACLIDINIUM BROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012   Start Trial   Start Trial
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ACLIDINIUM BROMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1200431 C01200431/01 Switzerland   Start Trial PRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013
1200431 1390002-2 Sweden   Start Trial PRODUCT NAME: AKLIDINIUMSALT MED FARMACEUTISKT ACCEPTABEL ANJON AV EN- ELLER FLERVAERD SYRA, SPECIELLT AKLIDINIUMBROMID; REG. NO/DATE: EU/1/12/778/001 20120720
1200431 CA 2013 00002 Denmark   Start Trial
1200431 C 2013 002 Romania   Start Trial PRODUCT NAME: SAREDE ACLIDINIU CU UN ANION ACCEPTABIL FARMACEUTIC AL UNUI ACID MONO SAU POLIVALENT, IN SPECIAL BROMURA DEACLIDINIU; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/778/001, RO EU/1/12/778/002, RO EU/1/12/778/003; DATE OF NATIONAL AUTHORISATION: 20120720; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/778/001, EMEA EU/1/12/778/002, EMEA EU/1/12/778/003; DATE OF FIRST AUTHORISATION IN EEA: 20120720
1200431 2013C/001 Belgium   Start Trial PRODUCT NAME: SEL D'ACLIDINIUM AVEC UN ANION PHARMACEUTIQUEMENT ACCEPTABLE D'UN ACIDE MONO OU POLYVALENT EN PARTICULIER LE BROMURE D'ACLIDINIUM; AUTHORISATION NUMBER AND DATE: EU/1/12/781/001 20120725
1200431 13C0001 France   Start Trial PRODUCT NAME: SEL D'ACLIDINIUM AVEC UN ANION PHARMACEUTIQUEMENT ACCEPTABLE D'UN ACIDE MONO OU POLYVALENT, EN PARTICULIER LE BROMURE D'ACLIDINIUM; REGISTRATION NO/DATE: EU/1/12/778/001-003 20120720
1200431 PA2013001,C1200431 Lithuania   Start Trial PRODUCT NAME: ACLIDINII BROMIDUM; REGISTRATION NO/DATE: EU/1/12/778/001 - EU/1/12/778/003, 2012 07 20 EU/1/12/781/001 - EU/1/12/781/003 20120720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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