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 patent protection?
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-six patent family members in thirty-two countries.
One supplier is listed for this compound.
Summary for formoterol fumarate; glycopyrrolate
International Patents: | 186 |
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 Cholinergic Muscarinic Antagonist beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for formoterol fumarate; glycopyrrolate
US Patents and Regulatory Information for formoterol fumarate; glycopyrrolate
International Patents for formoterol fumarate; glycopyrrolate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Croatia | P20161101 | ⤷ Sign Up | |
Croatia | P20200298 | ⤷ Sign Up | |
Hong Kong | 1169026 | 用於經由肺部遞送長效蕈毒鹼拮抗劑及長效β 腎上腺素受體激動劑之組成物,及相關方法及系統 (COMPOSITIONS FOR PULMONARY DELIVERY OF LONG-ACTING MUSCARINIC ANTAGONISTS AND LONG-ACTING BETA ADRENERGIC RECEPTOR AGONISTS AND ASSOCIATED METHODS AND SYSTEMS) | ⤷ Sign Up |
Japan | 2016041713 | 長時間作用性のムスカリン拮抗剤および長時間作用性のΒ2アドレナリン受容体作動剤を肺送達するための組成物ならびに関連の方法および系 (COMPOSITIONS FOR PULMONARY DELIVERY OF LONG-ACTING MUSCARINIC ANTAGONISTS AND LONG-ACTING BETA2 ADRENERGIC RECEPTOR AGONISTS AND ASSOCIATED METHODS AND SYSTEMS) | ⤷ Sign Up |
Taiwan | I539979 | ⤷ Sign Up | |
Poland | 2435024 | ⤷ Sign Up | |
Ukraine | 109529 | КОМПОЗИЦІЇ ДЛЯ РЕСПІРАТОРНОЇ ДОСТАВКИ АКТИВНИХ АГЕНТІВ ТА ПОВ'ЯЗАНІ СПОСОБИ І СИСТЕМИ | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for formoterol fumarate; glycopyrrolate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2435025 | C201930043 | Spain | ⤷ Sign Up | 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 |
2435024 | 2190014-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210 |
2435024 | C02435024/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021 |
2435024 | PA2021511,C2435024 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209 |
2435024 | 301102 | Netherlands | ⤷ Sign Up | 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 | PA2021511 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209 |
2435025 | PA2019014 | Lithuania | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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