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Last Updated: January 30, 2023

Aclidinium bromide - Generic Drug Details


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What are the generic drug sources for aclidinium bromide and what is the scope of patent protection?

Aclidinium bromide is the generic ingredient in two branded drugs marketed by Covis and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aclidinium bromide has one hundred and fifty-nine 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:159
US Patents:5
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 52
Clinical Trials: 39
Patent Applications: 1,023
What excipients (inactive ingredients) are in aclidinium bromide?aclidinium bromide excipients list
DailyMed Link:aclidinium bromide at DailyMed
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 Action Cholinergic 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 TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Covis DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Covis DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 See Plans and Pricing See Plans and Pricing
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 See Plans and Pricing See Plans and Pricing
Covis TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 See Plans and Pricing See Plans and Pricing
>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
European Patent Office 2100599 Composition à inhaler comprenant aclidinium pour le traitement de l'asthme et de maladies respiratoires obstructives chroniques (Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009112274 See Plans and Pricing
Norway 329484 See Plans and Pricing
Spain 2551307 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for aclidinium bromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1200431 SPC/GB13/006 United Kingdom See Plans and Pricing 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 PA2013001 Lithuania See Plans and Pricing 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 132013902117495 Italy See Plans and Pricing 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
1200431 C300573 Netherlands See Plans and Pricing PRODUCT NAME: ACLIDINIUMZOUT MET EEN FARMACEUTISCH AANVAARDBAAR ANION VAN EEN EEN- OF MEERWAARDIG ZUUR, IN HET BIJZONDER ACLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/12/778/001-003EU/1/12/781/001-003 2012200720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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