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Last Updated: August 11, 2020

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Aclidinium bromide; formoterol fumarate - Generic Drug Details

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What are the generic drug 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 Circassia and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There is one drug master file entry for aclidinium bromide; formoterol fumarate.

Summary for aclidinium bromide; formoterol fumarate
International Patents:142
US Patents:11
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Clinical Trials: 16
DailyMed Link:aclidinium bromide; formoterol fumarate at DailyMed
Recent Clinical Trials for aclidinium bromide; formoterol fumarate

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

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

See all aclidinium bromide; formoterol fumarate clinical trials

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
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX No No   Start Trial   Start Trial   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; formoterol fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019   Start Trial   Start Trial
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019   Start Trial   Start Trial
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for aclidinium bromide; formoterol fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1200431 SPC/GB13/006 United Kingdom   Start Trial PRODUCT NAME: ACLIDINIUM SALT WITH PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; REGISTERED: UK EU/1/12/778/001 20120720; UK EU/1/12/778/002 20120720; UK EU/1/12/778/003 20120720; UK EU/1/12/781/001 20120720; UK EU/1/12/781/002 20120720; UK EU/1/12/781/003 20120720
1200431 421 Finland   Start Trial
1200431 132013902117495 Italy   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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