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Last Updated: November 26, 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. One supplier is 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: 1
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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Covis DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Covis DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Covis DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Sign Up ⤷  Sign Up
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Sign Up ⤷  Sign Up
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Sign Up ⤷  Sign Up
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ⤷  Sign Up ⤷  Sign Up
>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
Russian Federation 2007105156 ИНГАЛЯТОР И КАРТРИДЖ ДЛЯ ЛЕКАРСТВЕННОГО ПОРОШКОВОГО ПРЕПАРАТА И СПОСОБ ИНГАЛЯЦИИ ⤷  Sign Up
Poland 2954891 ⤷  Sign Up
Czech Republic 2002121 ⤷  Sign Up
South Korea 20070007396 ⤷  Sign Up
Spain 2353018 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ACLIDINIUM BROMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1200431 PA2013001,C1200431 Lithuania ⤷  Sign Up 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 421 Finland ⤷  Sign Up
1200431 2013/002 Ireland ⤷  Sign Up 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 92132 Luxembourg ⤷  Sign Up PRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM
1200431 1390002-2 Sweden ⤷  Sign Up PRODUCT NAME: AKLIDINIUMSALT MED FARMACEUTISKT ACCEPTABEL ANJON AV EN- ELLER FLERVAERD SYRA, SPECIELLT AKLIDINIUMBROMID; REG. NO/DATE: EU/1/12/778/001 20120720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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