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Last Updated: March 28, 2024

Formoterol fumarate; glycopyrrolate - Generic Drug Details


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What are the generic sources for formoterol fumarate; glycopyrrolate and what is the scope of freedom to operate?

Formoterol fumarate; glycopyrrolate is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Formoterol fumarate; glycopyrrolate has one hundred and eighty-four patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for formoterol fumarate; glycopyrrolate
International Patents:184
US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 4
DailyMed Link:formoterol fumarate; glycopyrrolate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for formoterol fumarate; glycopyrrolate
Generic Entry Date for formoterol fumarate; glycopyrrolate*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, 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 formoterol fumarate; glycopyrrolate

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

SponsorPhase
Chiesi Farmaceutici S.p.A.Phase 3
Pearl Therapeutics, Inc.Phase 3
Pearl Therapeutics, Inc.Phase 2

See all formoterol fumarate; glycopyrrolate clinical trials

Pharmacology for formoterol fumarate; glycopyrrolate

US Patents and Regulatory Information for formoterol fumarate; glycopyrrolate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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

International Patents for formoterol fumarate; glycopyrrolate

Country Patent Number Title Estimated Expiration
Israel 216466 תכשירים לנתינה למערכת הנשימה של גורמים פעילים ושיטות ומערכות קשורות (Compositions for respiratory delivery of active agents and associated methods and systems) ⤷  Try a Trial
Taiwan I633898 ⤷  Try a Trial
Croatia P20161101 ⤷  Try a Trial
San Marino T201600327 COMPOSIZIONI PER IL RILASCIO POLMONARE DI ANTAGONISTI MUSCARINICI AD AZIONE PROLUNGATA E DI AGONISTI DEL RECETTORE ADRENERGICO BETA 2 AD AZIONE PROLUNGATA E METODI E SISTEMI ASSOCIATI ⤷  Try a Trial
Ukraine 109530 КОМПОЗИЦІЇ, СПОСОБИ ТА СИСТЕМИ ДЛЯ ДОСТАВКИ РЕСПІРАТОРНИМ ШЛЯХОМ ДВОХ ЧИ БІЛЬШЕ АКТИВНИХ АГЕНТІВ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for formoterol fumarate; glycopyrrolate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 2021019 Norway ⤷  Try a Trial PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216
2435024 21C1020 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024 C02435024/01 Switzerland ⤷  Try a Trial PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021
2435024 15/2021 Austria ⤷  Try a Trial PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
2435025 2019026 Norway ⤷  Try a Trial PRODUCT NAME: KOMBINASJON AV GLYKOPYRROLAT (INKLUDERT EVENTUELLE FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV) OG FORMOTEROL (INNBEFATTENDE HVILKE SOM HELST FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV); REG. NO/DATE: EU/1/18/1339 20190104
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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