Budesonide; formoterol fumarate; glycopyrrolate - Generic Drug Details

What are the generic drug sources for budesonide; formoterol fumarate; glycopyrrolate and what is the scope of freedom to operate?

Budesonide; formoterol fumarate; glycopyrrolate is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Budesonide; formoterol fumarate; glycopyrrolate has two hundred and five patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for budesonide; formoterol fumarate; glycopyrrolate

International Patents:	205
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	budesonide; formoterol fumarate; glycopyrrolate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for budesonide; formoterol fumarate; glycopyrrolate

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 budesonide; formoterol fumarate; glycopyrrolate

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

Anatomical Therapeutic Chemical (ATC) Classes for budesonide; formoterol fumarate; glycopyrrolate

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

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

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

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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

R03CC	Selective beta-2-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for budesonide; formoterol fumarate; glycopyrrolate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes			Y
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes			Y
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes			Y

International Patents for budesonide; formoterol fumarate; glycopyrrolate

Country	Patent Number	Title	Estimated Expiration
Poland	2435023
World Intellectual Property Organization (WIPO)	2010138868
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)
European Patent Office	3111926	COMPOSITIONS, PROCÉDÉS ET SYSTÈMES POUR UNE ADMINISTRATION RESPIRATOIRE DE DEUX OU DE PLUSIEURS AGENTS ACTIFS (COMPOSITIONS, METHODS & SYSTEMS FOR RESPIRATORY DELIVERY OF TWO OR MORE ACTIVE AGENTS)
Taiwan	I632926

Supplementary Protection Certificates for budesonide; formoterol fumarate; glycopyrrolate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2435025	2019026	Norway		PRODUCT NAME: KOMBINASJON AV GLYKOPYRROLAT (INKLUDERT EVENTUELLE FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV) OG FORMOTEROL (INNBEFATTENDE HVILKE SOM HELST FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV); REG. NO/DATE: EU/1/18/1339 20190104
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
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	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