Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

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 ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There is one drug master file entry for aclidinium bromide; formoterol fumarate. One supplier is listed for this compound.

Summary for aclidinium bromide; formoterol fumarate
International Patents:131
US Patents:10
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 1
Clinical Trials: 16
DailyMed Link:aclidinium bromide; formoterol fumarate at DailyMed
Recent Clinical Trials for aclidinium bromide; formoterol fumarate

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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

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
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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for aclidinium bromide; formoterol fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 92132 Luxembourg   Start Trial PRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM
1200431 CA 2013 00002 Denmark   Start Trial
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 C01200431/01 Switzerland   Start Trial PRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
McKesson
Merck
Johnson and Johnson
Mallinckrodt

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