Aclidinium bromide - Generic Drug Details

✉ Email this page to a colleague

What are the generic 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 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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
AstraZeneca	Phase 1
QuintilesIMS, Inc.	Phase 4
Center for Integrated Rehabilitation and Organ Failure Horn	Phase 4

See all aclidinium bromide clinical trials

Pharmacology for aclidinium bromide

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for aclidinium bromide

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for aclidinium bromide

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	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
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	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	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	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

Subscribe to access the full database, or Sign Up
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
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

Subscribe to access the full database, or Sign Up
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

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Australia	2005202144		⤷ Sign Up
Brazil	PI0905775	composição farmacêutica para inalação, método de tratar uma condição respiratória, uso de aclidínio, aclidínio, formulação e dispositivo inalador	⤷ Sign Up
South Korea	20070009744		⤷ Sign Up
Serbia	54241	JEDINJENJE ZA INHALACIJU KOJE SADRŽI AKLIDINIJUM ZA LEČENJE HRONIČNE OPSTRUKTIVNE BOLESTI PLUĆA (INHALATION COMPOSITION CONTAINING ACLIDINIUM FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE)	⤷ Sign Up
Portugal	2954889		⤷ Sign Up
Hungary	E027726		⤷ Sign Up
China	104473911	Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for aclidinium bromide

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	1/2013	Austria	⤷ Sign Up	PRODUCT NAME: ACLIDINIUMSALZ MIT EINEM PHARMAZEUTISCH ANNEHMBAREN ANION EINER MONO- ODER POLYVALENTEN SAEURE INSBESONDERE ALS ACLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/12/778/001-003 EU/1/12/781/001-003 20120720
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
1200431	C01200431/01	Switzerland	⤷ Sign Up	PRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013
1200431	13C0001	France	⤷ Sign Up	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	C300573	Netherlands	⤷ Sign Up	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
1200431	PA2013001	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.