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-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 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 |
---|---|---|---|
South Korea | 101976107 | ⤷ Sign Up | |
Argentina | 076806 | COMPOSICIONES PARA EL SUMINISTRO DE AGENTES ACTIVOS MEDIANTE LAS VIAS RES-PIRATORIAS, Y METODOS Y SISTEMAS ASOCIADOS, COSUSPENSION, INHALADOR DOSIFI-CADOR | ⤷ Sign Up |
Russian Federation | 2751771 | КОМПОЗИЦИИ ДЛЯ РЕСПИРАТОРНОЙ ДОСТАВКИ АКТИВНЫХ ВЕЩЕСТВ И СВЯЗАННЫЕ С НИМИ СПОСОБЫ И СИСТЕМЫ (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE SUBSTANCES AND METHODS AND SYSTEMS ASSOCIATED THEREWITH) | ⤷ Sign Up |
China | 102458364 | Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting b2 adrenergic receptor agonists and associated methods and systems | ⤷ Sign Up |
South Korea | 20180130602 | 활성제의 호흡기 전달용 조성물, 및 연관된 방법 및 시스템 (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE AGENTS AND ASSOCIATED METHODS AND SYSTEMS) | ⤷ Sign Up |
Spain | 2774367 | ⤷ 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 |
---|---|---|---|---|
0613371 | 2002C/022 | Belgium | ⤷ Sign Up | PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825 |
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 | 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 | LUC00124 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220 |
2435025 | 122019000068 | Germany | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON GLYCOPYRROLAT, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON, UND FORMOTEROL, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
2435024 | 2021C/518 | Belgium | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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