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Last Updated: April 24, 2024

Aclidinium bromide; formoterol fumarate - Generic Drug Details

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

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	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
>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
Norway	2013002		⤷ Try a Trial
Mexico	2010008235	NUEVA DOSIFICACION Y FORMULACION. (NOVEL DOSAGE AND FORMULATION.)	⤷ Try a Trial
South Africa	201003900	NOVEL DOSAGE AND FORMULATION	⤷ Try a Trial
Finland	2265257		⤷ Try a Trial
European Patent Office	2954891	COMPOSITION À INHALER COMPRENANT DE L'ACLIDINIUM POUR LE TRAITEMENT DE L'ASTHME (INHALATION COMPOSITION CONTAINING ACLIDINIUM FOR TREATMENT OF ASTHMA)	⤷ Try a Trial
Argentina	029760	DERIVADOS DE QUINUCLIDINA, PROCESO PARA PREPARAR DICHOS DERIVADOS, COMPUESTOS INTERMEDIARIOS UTILIZABLES EN DICHO PROCESO, COMPOSICIONES FARMACEUTICAS FORMULADAS CON DICHOS DERIVADOS Y USO DE DICHOS DERIVADOS PARA LA PRODUCCION DE MEDICAMENTOS PARA EL TRATAMIENTO DE ENFERMEDADES RESPIRATORIAS, URINA	⤷ Try a Trial
South Africa	200700049	Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler	⤷ 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	SPC/GB13/006	United Kingdom	⤷ Try a Trial	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,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	CA 2013 00002	Denmark	⤷ Try a Trial
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
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	1/2013	Austria	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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