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Last Updated: July 16, 2024

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AIRSUPRA Drug Patent Profile


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When do Airsupra patents expire, and what generic alternatives are available?

Airsupra is a drug marketed by Astrazeneca and is included in one NDA. There is one patent protecting this drug.

This drug has one hundred and eighty-four patent family members in thirty-one countries.

The generic ingredient in AIRSUPRA is albuterol sulfate; budesonide. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the albuterol sulfate; budesonide profile page.

DrugPatentWatch® Generic Entry Outlook for Airsupra

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 10, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for AIRSUPRA
International Patents:184
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Formulation / Manufacturing:see details
Drug Prices: Drug price information for AIRSUPRA
What excipients (inactive ingredients) are in AIRSUPRA?AIRSUPRA excipients list
DailyMed Link:AIRSUPRA at DailyMed
Drug patent expirations by year for AIRSUPRA
Drug Prices for AIRSUPRA

See drug prices for AIRSUPRA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AIRSUPRA
Generic Entry Date for AIRSUPRA*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
NDA:
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.

US Patents and Regulatory Information for AIRSUPRA

AIRSUPRA is protected by one US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AIRSUPRA is ⤷  Sign Up.

This potential generic entry date is based on NEW PRODUCT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting AIRSUPRA

Compositions, methods and systems for respiratory delivery of two or more active agents
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: AS-NEEDED TREATMENT OR PREVENTION OF BRONCHOCONSTRICTION AND REDUCTION OF THE RISK OF EXACERBATIONS IN PATIENTS WITH ASTHMA 18 YEARS OF AGE AND OLDER

FDA Regulatory Exclusivity protecting AIRSUPRA

NEW PRODUCT
Exclusivity Expiration: ⤷  Sign Up

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 AIRSUPRA

See the table below for patents covering AIRSUPRA around the world.

Country Patent Number Title Estimated Expiration
South Korea 20120026075 RESPIRATORY DELIVERY OF ACTIVE AGENTS ⤷  Sign Up
Denmark 2435024 ⤷  Sign Up
Argentina 076806 COMPOSICIONES PARA EL SUMINISTRO DE AGENTES ACTIVOS MEDIANTE LAS VIAS RES-PIRATORIAS, Y METODOS Y SISTEMAS ASOCIADOS, COSUSPENSION, INHALADOR DOSIFI-CADOR ⤷  Sign Up
Norway 2021019 ⤷  Sign Up
Slovenia 2435024 ⤷  Sign Up
China 102458364 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 AIRSUPRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435025 PA2019014 Lithuania ⤷  Sign Up 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 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
2435024 15/2021 Austria ⤷  Sign Up PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
2435025 36/2019 Austria ⤷  Sign Up PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
2435025 LUC00124 Luxembourg ⤷  Sign Up 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 CA 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
>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.