BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE - Generic Drug Details
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What are the generic drug sources for budesonide; formoterol fumarate; glycopyrrolate and what is the scope of freedom to operate?
Budesonide; formoterol fumarate; glycopyrrolate
is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Budesonide; formoterol fumarate; glycopyrrolate has two hundred and eight patent family members in thirty-four countries.
One supplier is listed for this compound.
Summary for BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
International Patents: | 208 |
US Patents: | 9 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
DailyMed Link: | BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
Generic Entry Date for BUDESONIDE; 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.
Pharmacology for BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Ab | BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122-001 | Jul 23, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca Ab | BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122-001 | Jul 23, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122-001 | Jul 23, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122-001 | Jul 23, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca Ab | BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122-001 | Jul 23, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122-001 | Jul 23, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca Ab | BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122-001 | Jul 23, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for BUDESONIDE; 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 BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2435025 | 19C1040 | France | ⤷ Sign Up | 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 | 2021019 | Norway | ⤷ Sign Up | PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216 |
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 | 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 |
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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