ALBUTEROL SULFATE; BUDESONIDE - Generic Drug Details

What are the generic 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
Parexel	Phase 3
Bond Avillion 2 Development LP	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

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
Spain	2593429
Japan	6169639
China	107412212	经肺递送长效毒蕈碱拮抗剂及长效β2肾上腺素能受体激动剂的组合物及相关方法与系统 (Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting beta2 adrenergic receptor agonists and associated methods and systems)
Netherlands	300995
Lithuania	2435023

Supplementary Protection Certificates for ALBUTEROL SULFATE; BUDESONIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	122019000068	Germany		PRODUCT NAME: KOMBINATION VON GLYCOPYRROLAT, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON, UND FORMOTEROL, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1339 20181218
2435024	LUC00208	Luxembourg		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	PA2021511,C2435024	Lithuania		PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209
2435024	2021019	Norway		PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216
2435024	CR 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