Budesonide; formoterol fumarate; glycopyrrolate - Generic Drug Details
✉ Email this page to a colleague
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 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 | 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 | ⤷ 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 | |||
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 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 |
---|---|---|---|
Argentina | 076807 | COMPOSICIONES METODOS Y SISTEMAS PARA EL SUMINISTRO DE DOS O MAS AGENTES ACTIVOS MEDIANTE LAS VIAS RESPIRATORIAS. METODO DE PREPARACION COMPOSICION | ⤷ Try a Trial |
Argentina | 122477 | COMPOSICIONES PARA EL SUMINISTRO DE AGENTES ACTIVOS MEDIANTE LAS VÍAS RESPIRATORIAS, Y MÉTODOS Y SISTEMAS ASOCIADOS | ⤷ Try a Trial |
Cyprus | 1122807 | ⤷ Try a Trial | |
Taiwan | 201109050 | Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting &bgr;2 adrenergic receptor agonists and associated methods and systems | ⤷ Try a Trial |
South Korea | 20120026075 | RESPIRATORY DELIVERY OF ACTIVE AGENTS | ⤷ Try a Trial |
Australia | 2015201037 | Respiratory delivery of active agents | ⤷ 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 | 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 |
2435025 | 2019C/532 | Belgium | ⤷ Try a Trial | PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220 |
2435024 | 122021000026 | Germany | ⤷ Try a Trial | PRODUCT NAME: GLYCOPYRROLAT MIT FORMOTEROL MIT BUDESONID, ODER SALZE, ESTER, SOLVATE, ENANTIOMERE UND MISCHUNGEN VON ENANTIOMEREN DERSELBEN; REGISTRATION NO/DATE: EU/1/20/1498 20201209 |
2435024 | 2021019 | Norway | ⤷ Try a Trial | PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216 |
2435024 | 132021000000095 | Italy | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210 |
2435024 | 21C1020 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.