FORMOTEROL FUMARATE; GLYCOPYRROLATE - Generic Drug Details

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

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

Formoterol fumarate; glycopyrrolate has one hundred and eighty-five patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for FORMOTEROL FUMARATE; GLYCOPYRROLATE

International Patents:	185
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
DailyMed Link:	FORMOTEROL FUMARATE; GLYCOPYRROLATE at DailyMed

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

Recent Clinical Trials for FORMOTEROL FUMARATE; GLYCOPYRROLATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Chiesi Farmaceutici S.p.A.	Phase 3
Pearl Therapeutics, Inc.	Phase 3
Pearl Therapeutics, Inc.	Phase 2

See all FORMOTEROL FUMARATE; GLYCOPYRROLATE clinical trials

Pharmacology for FORMOTEROL FUMARATE; GLYCOPYRROLATE

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

US Patents and Regulatory Information for 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	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes			Y
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes			Y
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes			Y
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes

International Patents for FORMOTEROL FUMARATE; GLYCOPYRROLATE

Country	Patent Number	Title	Estimated Expiration
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)
Cyprus	1122749
Russian Federation	2713404	КОМПОЗИЦИИ ДЛЯ ЛЕГОЧНОЙ ДОСТАВКИ АНТАГОНИСТОВ МУСКАРИНОВЫХ РЕЦЕПТОРОВ ДЛИТЕЛЬНОГО ДЕЙСТВИЯ И АГОНИСТОВ В2-АДРЕНЕРГИЧЕСКИХ РЕЦЕПТОРОВ ДЛИТЕЛЬНОГО ДЕЙСТВИЯ И СВЯЗАННЫЕ С НИМИ СПОСОБЫ И СИСТЕМЫ (COMPOSITIONS FOR PULMONARY DELIVERY OF LONG-ACTING MUSCARINIC RECEPTOR ANTAGONISTS AND LONG-ACTING B2-ADRENERGIC RECEPTOR AGONISTS AND METHODS AND SYSTEMS ASSOCIATED THEREWITH)
Spain	2593429
Brazil	PI1011508	composição farmacêutica, métodos para tratar uma doença ou distúrbio pulmonar em um paciente ou população de pacientes, e para dispensação respiratória de um agente ativo a um paciente, e, inalador de dose medida.

Supplementary Protection Certificates for FORMOTEROL FUMARATE; GLYCOPYRROLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	C02435024/01	Switzerland		PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
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
2435024	15/2021	Austria		PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
2435025	PA2019014,C2435025	Lithuania		PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218