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Last Updated: March 28, 2024

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 Covis and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for ACLIDINIUM BROMIDE
International Patents:156
US Patents:4
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 56
Clinical Trials: 39
Patent Applications: 783
What excipients (inactive ingredients) are in ACLIDINIUM BROMIDE?ACLIDINIUM BROMIDE excipients list
DailyMed Link:ACLIDINIUM BROMIDE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ACLIDINIUM BROMIDE
Generic Entry Date for ACLIDINIUM BROMIDE*:
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

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

SponsorPhase
AstraZenecaPhase 1
QuintilesIMS, Inc.Phase 4
Maastricht University Medical CenterPhase 4

See all ACLIDINIUM BROMIDE clinical trials

Pharmacology for ACLIDINIUM BROMIDE
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists

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
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 TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 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 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 TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 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

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

EU/EMA Drug Approvals for ACLIDINIUM BROMIDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Covis Pharma Europe B.V. Bretaris Genuair aclidinium bromide EMEA/H/C/002706
Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Authorised no no no 2012-07-20
Covis Pharma Europe B.V. Eklira Genuair aclidinium bromide EMEA/H/C/002211
Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Authorised no no no 2012-07-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ACLIDINIUM BROMIDE

Country Patent Number Title Estimated Expiration
Spain 2916831 ⤷  Try a Trial
Slovenia 1616592 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2009112274 ⤷  Try a Trial
Czech Republic 2002121 ⤷  Try a Trial
European Patent Office 1200431 DERIVES DE QUINUCLIDINE ET LEUR UTILISATION COMME LIGANDS DES RECEPTEURS M3 MUSCARINIQUES (QUINUCLIDINE DERIVATIVES AND THEIR USE AS MUSCARINIC M3 RECEPTORS LIGANDS) ⤷  Try a Trial
Spain 2353018 ⤷  Try a Trial
Germany 602005023690 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ACLIDINIUM BROMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1200431 PA2013001 Lithuania ⤷  Try a 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 CA 2013 00002 Denmark ⤷  Try a Trial
1200431 2013/002 Ireland ⤷  Try a Trial PRODUCT NAME: ACLIDINIUM SALT WITH A PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; NAT REGISTRATION NO/DATE: EU/1/12/778/001-003 20120720; FIRST REGISTRATION NO/DATE: EU/1/12/781/001-003 20/07/2012 EUROPEAN UNION EU/1/12/778/001-003 20/07/2012 EUROPEAN UNION EU/1/12/781/001-003 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 PA2013001,C1200431 Lithuania ⤷  Try a 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 92132 Luxembourg ⤷  Try a Trial PRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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