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-five patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for FORMOTEROL FUMARATE; GLYCOPYRROLATE
International Patents: | 185 |
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 |
---|---|---|---|
China | 102458364 | Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting b2 adrenergic receptor agonists and associated methods and systems | ⤷ Try a Trial |
Japan | 2015187108 | 活性剤を呼吸器送達するための組成物、ならびに関連する方法および系 (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE AGENTS AND ASSOCIATED METHODS AND SYSTEMS) | ⤷ Try a Trial |
Hong Kong | 1169307 | 經由呼吸道遞送活性藥劑 (RESPIRATORY DELIVERY OF ACTIVE AGENTS) | ⤷ Try a Trial |
South Korea | 101976107 | ⤷ Try a Trial | |
Slovenia | 2435023 | ⤷ Try a Trial | |
South Korea | 20170070274 | 지속형 무스카린 안타고니스트 및 지속형 B₂아드레날린 수용체 아고니스트의 폐 전달용 조성물, 및 연관된 방법 및 시스템 (COMPOSITIONS FOR PULMONARY DELIVERY OF LONG-ACTING MUSCARINIC ANTAGONISTS AND LONG-ACTING B2 ADRENERGIC RECEPTOR AGONISTS AND ASSOCIATED METHODS AND SYSTEMS) | ⤷ Try a Trial |
South Africa | 201208102 | RESPIRATORY DELIVERY OF ACTIVE AGENTS | ⤷ 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 | CR 2021 00014 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210 |
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 |
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 |
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 |
2435024 | 2021C/518 | Belgium | ⤷ Try a Trial | PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210 |
2435025 | 19C1040 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220 |
0613371 | 2002C/022 | Belgium | ⤷ Try a Trial | PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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