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*:
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; FORMOTEROL FUMARATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
QuintilesIMS, Inc. | Phase 4 |
Maastricht University Medical Center | Phase 4 |
Center for Integrated Rehabilitation and Organ Failure Horn | 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
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
International Patents for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
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 |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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