Albuterol sulfate; budesonide - Generic Drug Details

What are the generic drug sources for albuterol sulfate; budesonide and what is the scope of freedom to operate?

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

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

Sponsor	Phase
Bond Avillion 2 Development LP	Phase 3
Parexel	Phase 3
AstraZeneca	Phase 1

See all albuterol sulfate; budesonide clinical trials

Pharmacology for albuterol sulfate; budesonide

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

Anatomical Therapeutic Chemical (ATC) Classes for albuterol sulfate; budesonide

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

International Patents for albuterol sulfate; budesonide

Country	Patent Number	Title	Estimated Expiration
Lithuania	2435025
Poland	2435025
Slovenia	2435024
Taiwan	201109051	Compositions, methods and systems for respiratory delivery of two or more active agents
Taiwan	I646980
Australia	2010253776	Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting B2 adrenergic receptor agonists and associated methods and systems
Hong Kong	1169027	用於經由呼吸道輸送活性劑的組成物以及相關方法與系統 (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE AGENTS AND ASSOCIATED METHODS AND SYSTEMS)

Supplementary Protection Certificates for albuterol sulfate; budesonide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	19C1040	France		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
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	CA 2019 00032	Denmark		PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
2435025	132019000000087	Italy		PRODUCT NAME: UNA COMBINAZIONE DI GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI) E FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI)(BEVESPI AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1339, 20181220
2435025	PA2019014	Lithuania		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
2435024	CA 2021 00014	Denmark		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
2435024	C202130025	Spain		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