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Last Updated: November 24, 2024

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: 30
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

SponsorPhase
Cipla Ltd.Phase 3
ShiYue LiN/A
AstraZenecaN/A

See all BUDESONIDE; FORMOTEROL FUMARATE clinical trials

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
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 AB 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 SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 AB 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

Country Patent Number Title Estimated Expiration
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) ⤷  Sign Up
Taiwan 201109050 Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting &bgr;2 adrenergic receptor agonists and associated methods and systems ⤷  Sign Up
South Korea 20120026075 RESPIRATORY DELIVERY OF ACTIVE AGENTS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BUDESONIDE; FORMOTEROL FUMARATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435025 PA2019014,C2435025 Lithuania ⤷  Sign Up PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
2435024 C202130025 Spain ⤷  Sign Up 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 CR 2019 00032 Denmark ⤷  Sign Up PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER SOLVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.