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Last Updated: May 19, 2024

ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE - Generic Drug Details

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What are the generic 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 Covis and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Two suppliers are listed for this compound.

Summary for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

International Patents:	156
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	16
DailyMed Link:	ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

Generic Entry Date for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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; FORMOTEROL FUMARATE

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

Sponsor	Phase
QuintilesIMS, Inc.	Phase 4
Center for Integrated Rehabilitation and Organ Failure Horn	Phase 4
Maastricht University Medical Center	Phase 4

See all ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE clinical trials

Pharmacology for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

Drug Class	Anticholinergic beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists

US Patents and Regulatory Information for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

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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	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	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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	⤷ Try a Trial	⤷ Try a Trial
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	⤷ Try a Trial	⤷ Try a Trial
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	⤷ Try a Trial	⤷ Try a Trial
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	⤷ Try a Trial	⤷ Try a Trial
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	⤷ Try a Trial	⤷ Try a Trial
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	⤷ Try a Trial	⤷ Try a Trial
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

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Country	Patent Number	Title	Estimated Expiration
Canada	2716724	NOUVEAU DOSAGE ET NOUVELLE FORMULATION (NOVEL DOSAGE AND FORMULATION)	⤷ Try a Trial
South Africa	200200232	Quinuclidine derivatives and their use as muscarinic M3 receptor ligands.	⤷ Try a Trial
Hong Kong	1145815	治療慢性阻塞性肺氣腫的包含阿地尼亞的吸入式組合物 (INHALATION COMPOSITION CONTAINING ACLIDINIUM FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE)	⤷ Try a Trial
Slovenia	1616592		⤷ Try a Trial
Colombia	5200759	NUEVOS DERIVADOS DE QUINUCLIDINA Y COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN	⤷ Try a Trial
Japan	2016130248	新規薬用量および製剤 (NOVEL DOSAGE AND FORMULATION)	⤷ Try a Trial
Denmark	2265257		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C 2013 002	Romania	⤷ Try a Trial	PRODUCT NAME: SAREDE ACLIDINIU CU UN ANION ACCEPTABIL FARMACEUTIC AL UNUI ACID MONO SAU POLIVALENT, IN SPECIAL BROMURA DEACLIDINIU; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/778/001, RO EU/1/12/778/002, RO EU/1/12/778/003; DATE OF NATIONAL AUTHORISATION: 20120720; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/778/001, EMEA EU/1/12/778/002, EMEA EU/1/12/778/003; DATE OF FIRST AUTHORISATION IN EEA: 20120720
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	C01200431/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013
1200431	132013902117495	Italy	⤷ Try a Trial	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	2013C/001	Belgium	⤷ 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; AUTHORISATION NUMBER AND DATE: EU/1/12/781/001 20120725
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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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.