You’re using a public version of DrugPatentWatch with 1 free search available | Register to unlock more free searches. CREATE FREE ACCOUNT

Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
AstraZeneca
McKinsey
Express Scripts
Merck

Last Updated: December 5, 2023

Budesonide; formoterol fumarate; glycopyrrolate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic 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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Budesonide; formoterol fumarate; glycopyrrolate has two hundred and four patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for budesonide; formoterol fumarate; glycopyrrolate
International Patents:204
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:budesonide; formoterol fumarate; glycopyrrolate at DailyMed
Pharmacology 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 ⤷  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
Denmark 3111926 ⤷  Try a Trial
China 102596176 Compositions for respiratory delivery of active agents and associated methods and systems ⤷  Try a Trial
Taiwan 201919730 Compositions for respiratory delivery of active agents and associated methods and systems ⤷  Try a Trial
Japan 2015199735 2つ以上の活性剤を呼吸器送達するための組成物、方法および系 (COMPOSITION, METHOD AND SYSTEM FOR DELIVERING TWO OR MORE ACTIVATORS TO RESPIRATORY ORGAN) ⤷  Try a Trial
Ukraine 109530 КОМПОЗИЦІЇ, СПОСОБИ ТА СИСТЕМИ ДЛЯ ДОСТАВКИ РЕСПІРАТОРНИМ ШЛЯХОМ ДВОХ ЧИ БІЛЬШЕ АКТИВНИХ АГЕНТІВ ⤷  Try a Trial
Croatia P20200166 ⤷  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 C201930043 Spain ⤷  Try a Trial 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 C202130025 Spain ⤷  Try a Trial PRODUCT NAME: UNA COMBINACION DE FORMOTEROL ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES I, GLICOPIRROLATO ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ) Y BUDESONIDA ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ).; NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1498; DATE OF FIRST AUTHORISATION IN EEA: 20201209
2435025 19C1040 France ⤷  Try a Trial 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 ⤷  Try a Trial PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216
2435025 LUC00124 Luxembourg ⤷  Try a Trial 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
McKinsey
Mallinckrodt
Baxter
Johnson and Johnson

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.