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Last Updated: November 28, 2021

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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 Astrazeneca and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for aclidinium bromide; formoterol fumarate
International Patents:138
US Patents:5
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
QuintilesIMS, Inc.Phase 4
Maastricht University Medical CenterPhase 4
Center for Integrated Rehabilitation and Organ Failure HornPhase 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
Astrazeneca DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Astrazeneca DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Astrazeneca DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Astrazeneca DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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
Astrazeneca DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 ⤷  Free Forever Trial ⤷  Free Forever 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 92132 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM
1200431 1390002-2 Sweden ⤷  Free Forever 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 PA2013001 Lithuania ⤷  Free Forever 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
1200431 C01200431/01 Switzerland ⤷  Free Forever 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:

Colorcon
AstraZeneca
Merck
Baxter
Moodys
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.