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-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 |
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 |
---|---|---|---|
European Patent Office | 3111926 | COMPOSITIONS, PROCÉDÉS ET SYSTÈMES POUR UNE ADMINISTRATION RESPIRATOIRE DE DEUX OU DE PLUSIEURS AGENTS ACTIFS (COMPOSITIONS, METHODS & SYSTEMS FOR RESPIRATORY DELIVERY OF TWO OR MORE ACTIVE AGENTS) | ⤷ Try a Trial |
Cyprus | 1122749 | ⤷ Try a Trial | |
Russian Federation | 2713404 | КОМПОЗИЦИИ ДЛЯ ЛЕГОЧНОЙ ДОСТАВКИ АНТАГОНИСТОВ МУСКАРИНОВЫХ РЕЦЕПТОРОВ ДЛИТЕЛЬНОГО ДЕЙСТВИЯ И АГОНИСТОВ В2-АДРЕНЕРГИЧЕСКИХ РЕЦЕПТОРОВ ДЛИТЕЛЬНОГО ДЕЙСТВИЯ И СВЯЗАННЫЕ С НИМИ СПОСОБЫ И СИСТЕМЫ (COMPOSITIONS FOR PULMONARY DELIVERY OF LONG-ACTING MUSCARINIC RECEPTOR ANTAGONISTS AND LONG-ACTING B2-ADRENERGIC RECEPTOR AGONISTS AND METHODS AND SYSTEMS ASSOCIATED THEREWITH) | ⤷ Try a Trial |
Spain | 2593429 | ⤷ Try a Trial | |
Brazil | PI1011508 | composição farmacêutica, métodos para tratar uma doença ou distúrbio pulmonar em um paciente ou população de pacientes, e para dispensação respiratória de um agente ativo a um paciente, e, inalador de dose medida. | ⤷ Try a Trial |
Hungary | S2100018 | ⤷ 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 | C02435024/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021 |
0613371 | SPC/GB02/033 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515 |
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 |
2435024 | 15/2021 | Austria | ⤷ Try a Trial | PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210 |
2435025 | PA2019014,C2435025 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; 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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