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AIRSUPRA Drug Patent Profile

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

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

See drug prices for AIRSUPRA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AIRSUPRA

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

214070

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 AIRSUPRA

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for AIRSUPRA

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for AIRSUPRA

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

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

FDA Regulatory Exclusivity protecting AIRSUPRA

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
Astrazeneca	AIRSUPRA	albuterol sulfate; budesonide	AEROSOL, METERED;INHALATION	214070-001	Jan 10, 2023		RX	Yes	Yes

International Patents for AIRSUPRA

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

Country	Patent Number	Title	Estimated Expiration
South Africa	201208102	RESPIRATORY DELIVERY OF ACTIVE AGENTS
Hong Kong	1218867	活性劑的呼吸遞送 (RESPIRATORY DELIVERY OF ACTIVE AGENTS)
Japan	6189356
Argentina	122477	COMPOSICIONES PARA EL SUMINISTRO DE AGENTES ACTIVOS MEDIANTE LAS VÍAS RESPIRATORIAS, Y MÉTODOS Y SISTEMAS ASOCIADOS

Supplementary Protection Certificates for AIRSUPRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	C201930043	Spain		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
2435025	LUC00124	Luxembourg		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
2435025	CR 2019 00032	Denmark		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	SPC/GB21/029	United Kingdom		PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210