BUDESONIDE; FORMOTEROL FUMARATE - Generic Drug Details
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What are the generic drug sources for budesonide; formoterol fumarate and what is the scope of freedom to operate?
Budesonide; formoterol fumarate
is the generic ingredient in four branded drugs marketed by Astrazeneca, Mylan, and Astrazeneca Ab, and is included in four NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Budesonide; formoterol fumarate has one hundred and eighty-five patent family members in thirty-one countries.
Summary for BUDESONIDE; FORMOTEROL FUMARATE
International Patents: | 185 |
US Patents: | 14 |
Tradenames: | 4 |
Applicants: | 3 |
NDAs: | 4 |
Clinical Trials: | 28 |
DailyMed Link: | BUDESONIDE; FORMOTEROL FUMARATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BUDESONIDE; FORMOTEROL FUMARATE
Generic Entry Date for BUDESONIDE; FORMOTEROL FUMARATE*:
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 BUDESONIDE; FORMOTEROL FUMARATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cipla Ltd. | Phase 3 |
ShiYue Li | N/A |
AstraZeneca | N/A |
US Patents and Regulatory Information for BUDESONIDE; FORMOTEROL FUMARATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | BREYNA | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 211699-001 | Mar 15, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-002 | Jul 21, 2006 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Astrazeneca Ab | BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122-001 | Jul 23, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Astrazeneca | SYMBICORT AEROSPHERE | budesonide; formoterol fumarate | AEROSOL, METERED;INHALATION | 216579-001 | Apr 28, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mylan | BREYNA | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 211699-002 | Mar 15, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101748892 | ⤷ Try a Trial | |
Hong Kong | 1218867 | 活性劑的呼吸遞送 (RESPIRATORY DELIVERY OF ACTIVE AGENTS) | ⤷ Try a Trial |
South Korea | 101926060 | ⤷ Try a Trial | |
Denmark | 2435023 | ⤷ Try a Trial | |
Russian Federation | 2011152960 | КОМПОЗИЦИИ ДЛЯ ЛЕГОЧНОЙ ДОСТАВКИ АНТАГОНИСТОВ МУСКАРИНОВЫХ РЕЦЕПТОРОВ ДЛИТЕЛЬНОГО ДЕЙСТВИЯ И АГОНИСТОВ β-АДРЕНЕРГИЧЕСКИХ РЕЦЕПТОРОВ ДЛИТЕЛЬНОГО ДЕЙСТВИЯ И СВЯЗАННЫЕ С НИМИ СПОСОБЫ И СИСТЕМЫ | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BUDESONIDE; FORMOTEROL FUMARATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2435024 | SPC/GB21/029 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210 |
2435024 | C02435024/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021 |
2435025 | PA2019014 | Lithuania | ⤷ Try a Trial | 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 |
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 | CA 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |