Formoterol fumarate; glycopyrrolate - Generic Drug Details
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What are the generic drug 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
Sponsor | Phase |
---|---|
Chiesi Farmaceutici S.p.A. | Phase 3 |
Pearl Therapeutics, Inc. | Phase 3 |
Pearl Therapeutics, Inc. | Phase 2 |
Pharmacology for formoterol fumarate; glycopyrrolate
Drug Class | Anticholinergic beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
US Patents and Regulatory Information for formoterol fumarate; glycopyrrolate
International Patents for formoterol fumarate; glycopyrrolate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 2435024 | ⤷ Try a Trial | |
Ukraine | 109529 | КОМПОЗИЦІЇ ДЛЯ РЕСПІРАТОРНОЇ ДОСТАВКИ АКТИВНИХ АГЕНТІВ ТА ПОВ'ЯЗАНІ СПОСОБИ І СИСТЕМИ | ⤷ Try a Trial |
Denmark | 3111927 | ⤷ Try a Trial | |
Russian Federation | 2015151358 | КОМПОЗИЦИИ ДЛЯ ЛЕГОЧНОЙ ДОСТАВКИ АНТАГОНИСТОВ МУСКАРИНОВЫХ РЕЦЕПТОРОВ ДЛИТЕЛЬНОГО ДЕЙСТВИЯ И АГОНИСТОВ В2-АДРЕНЕРГИЧЕСКИХ РЕЦЕПТОРОВ ДЛИТЕЛЬНОГО ДЕЙСТВИЯ И СВЯЗАННЫЕ С НИМИ СПОСОБЫ И СИСТЕМЫ | ⤷ Try a Trial |
Mexico | 337126 | ADMINISTRACION RESPIRATORIA DE AGENTES ACTIVOS. (RESPIRATORY DELIVERY OF ACTIVE AGENTS.) | ⤷ Try a Trial |
Montenegro | 03631 | SASTAVI ZA ISPORUKU AKTIVNIH AGENASA U DISAJNE PUTEVE I POVEZANI POSTUPCI I SISTEMI (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE AGENTS AND ASSOCIATED METHODS AND SYSTEMS) | ⤷ 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 | 301102 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210 |
2435024 | 132021000000095 | Italy | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210 |
2435025 | C201930043 | Spain | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINACION DE GLICOPIRROLATO (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES) Y FORMOTEROL (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES).; NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF AUTHORISATION: 20181218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1339; DATE OF FIRST AUTHORISATION IN EEA: 20181218 |
2435025 | CR 2019 00032 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER SOLVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220 |
2435025 | PA2019014 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) IR FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) DERINYS; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
2435024 | LUC00208 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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