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Last Updated: March 29, 2024

ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE - Generic Drug Details


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

Aclidinium bromide; formoterol fumarate is the generic ingredient in one branded drug marketed by Covis and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aclidinium bromide; formoterol fumarate has one hundred and fifty-six patent family members in forty-six countries.

Two suppliers are listed for this compound.

Summary for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
International Patents:156
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Clinical Trials: 16
DailyMed Link:ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Generic Entry Date for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER, METERED;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

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

SponsorPhase
QuintilesIMS, Inc.Phase 4
Center for Integrated Rehabilitation and Organ Failure HornPhase 4
Maastricht University Medical CenterPhase 4

See all ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE clinical trials

Pharmacology for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

US Patents and Regulatory Information for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Covis DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Covis DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Covis DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Covis DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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; FORMOTEROL FUMARATE

International Patents for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

Country Patent Number Title Estimated Expiration
Denmark 2265257 ⤷  Try a Trial
Croatia P20151214 ⤷  Try a Trial
Canada 2572790 INHALATEUR PERMETTANT L'ADMINISTRATION DE PRODUITS PHARMACEUTIQUES EN POUDRE, ET SYSTEME DE CARTOUCHE DE POUDRE DESTINE A CET INHALATEUR (INHALER FOR THE ADMINISTRATION OF POWDERED PHARMACEUTICALS, AND A POWDER CARTRIDGE SYSTEM FOR USE WITH THIS INHALER) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006008027 ⤷  Try a Trial
European Patent Office 2100599 Composition à inhaler comprenant aclidinium pour le traitement de l'asthme et de maladies respiratoires obstructives chroniques (Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease) ⤷  Try a Trial
Germany 60001840 ⤷  Try a Trial
Slovakia 432002 Novel quinuclidine derivatives and medicinal compositions containing the same ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1200431 C 2013 002 Romania ⤷  Try a 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 1/2013 Austria ⤷  Try a Trial PRODUCT NAME: ACLIDINIUMSALZ MIT EINEM PHARMAZEUTISCH ANNEHMBAREN ANION EINER MONO- ODER POLYVALENTEN SAEURE INSBESONDERE ALS ACLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/12/778/001-003 EU/1/12/781/001-003 20120720
1200431 421 Finland ⤷  Try a Trial
1200431 C300573 Netherlands ⤷  Try a Trial PRODUCT NAME: ACLIDINIUMZOUT MET EEN FARMACEUTISCH AANVAARDBAAR ANION VAN EEN EEN- OF MEERWAARDIG ZUUR, IN HET BIJZONDER ACLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/12/778/001-003EU/1/12/781/001-003 2012200720
1200431 132013902117495 Italy ⤷  Try a Trial PRODUCT NAME: BROMURO DI ACLIDINIO(EKLIRA GENUAIR E BRETARIS GENUAIR); AUTHORISATION NUMBER(S) AND DATE(S): BRETARIS G.: EU/1/12/781/001-002-003; EKLIRA G.:EU/1/12/778/001-002-003, 20120720
1200431 1390002-2 Sweden ⤷  Try a 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 13C0001 France ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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