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Last Updated: February 22, 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 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

SponsorPhase
QuintilesIMS, Inc.Phase 4
Maastricht University Medical CenterPhase 4
Center for Integrated Rehabilitation and Organ Failure HornPhase 4

See all aclidinium bromide; formoterol fumarate clinical trials

Pharmacology for aclidinium bromide; formoterol fumarate

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 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
>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

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for aclidinium bromide; formoterol fumarate

Country Patent Number Title Estimated Expiration
Hungary 0202100 ⤷  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
Uruguay 26244 NUEVOS DERIVADOS DE QUINUCLIDINA Y COMPOSICIONES FARMACÉUTICAS QUE LOS CONTIENEN. ⤷  Try a Trial
Japan 2014139233 NOVEL DOSAGE AND FORMULATION ⤷  Try a Trial
Slovakia 432002 Novel quinuclidine derivatives and medicinal compositions containing the same ⤷  Try a Trial
Slovenia 2954891 ⤷  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 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 C300573 Netherlands ⤷  Try a Trial 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 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 1390002-2 Sweden ⤷  Try a Trial PRODUCT NAME: AKLIDINIUMSALT MED FARMACEUTISKT ACCEPTABEL ANJON AV EN- ELLER FLERVAERD SYRA, SPECIELLT AKLIDINIUMBROMID; REG. NO/DATE: EU/1/12/778/001 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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