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 patent protection?
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 five patent family members in thirty-three countries.
One supplier is listed for this compound.
Summary for budesonide; formoterol fumarate; glycopyrrolate
International Patents: | 205 |
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
Drug Class | Anticholinergic Corticosteroid beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for budesonide; formoterol fumarate; glycopyrrolate
US Patents and Regulatory Information 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | ⤷ 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 | |||
>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 |
---|---|---|---|
Singapore | 11202003062Q | DRUG DELIVERY SYSTEMS AND RELATED METHODS | ⤷ Try a Trial |
Cyprus | 1118030 | ⤷ Try a Trial | |
Taiwan | 201642836 | Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting [beta]2 adrenergic receptor agonists and associated methods and systems | ⤷ Try a Trial |
>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 | 2019026 | Norway | ⤷ Try a Trial | PRODUCT NAME: KOMBINASJON AV GLYKOPYRROLAT (INKLUDERT EVENTUELLE FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV) OG FORMOTEROL (INNBEFATTENDE HVILKE SOM HELST FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV); REG. NO/DATE: EU/1/18/1339 20190104 |
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 | PA2019014,C2435025 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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