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Last Updated: November 24, 2024

Albuterol sulfate; budesonide - Generic Drug Details


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What are the generic sources for albuterol sulfate; budesonide and what is the scope of patent protection?

Albuterol sulfate; budesonide is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate; budesonide has one hundred and eighty-four patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for albuterol sulfate; budesonide
International Patents:184
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 3
DailyMed Link:albuterol sulfate; budesonide at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for albuterol sulfate; budesonide
Generic Entry Date for albuterol sulfate; budesonide*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
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 albuterol sulfate; budesonide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ParexelPhase 3
Bond Avillion 2 Development LPPhase 3
AstraZenecaPhase 1

See all albuterol sulfate; budesonide clinical trials

Pharmacology for albuterol sulfate; budesonide

US Patents and Regulatory Information for albuterol sulfate; budesonide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca AIRSUPRA albuterol sulfate; budesonide AEROSOL, METERED;INHALATION 214070-001 Jan 10, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca AIRSUPRA albuterol sulfate; budesonide AEROSOL, METERED;INHALATION 214070-001 Jan 10, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  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 albuterol sulfate; budesonide

Country Patent Number Title Estimated Expiration
Japan 2017222706 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 (COMPOSITIONS, METHODS AND SYSTEMS FOR RESPIRATORY DELIVERY OF TWO OR MORE ACTIVE AGENTS) ⤷  Sign Up
Russian Federation 2580315 КОМПОЗИЦИИ ДЛЯ РЕСПИРАТОРНОЙ ДОСТАВКИ АКТИВНЫХ ВЕЩЕСТВ И СВЯЗАННЫЕ С НИМИ СПОСОБЫ И СИСТЕМЫ (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE SUBSTANCES AND METHODS AND SYSTEMS CONNECTED THEREWITH) ⤷  Sign Up
Taiwan 201642836 Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting [beta]2 adrenergic receptor agonists and associated methods and systems ⤷  Sign Up
South Korea 20170070274 지속형 무스카린 안타고니스트 및 지속형 B₂아드레날린 수용체 아고니스트의 폐 전달용 조성물, 및 연관된 방법 및 시스템 (COMPOSITIONS FOR PULMONARY DELIVERY OF LONG-ACTING MUSCARINIC ANTAGONISTS AND LONG-ACTING B2 ADRENERGIC RECEPTOR AGONISTS AND ASSOCIATED METHODS AND SYSTEMS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for albuterol sulfate; budesonide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 LUC00208 Luxembourg ⤷  Sign Up 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 CR 2021 00014 Denmark ⤷  Sign Up 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
2435025 PA2019014,C2435025 Lithuania ⤷  Sign Up PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
2435024 301102 Netherlands ⤷  Sign Up PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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