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BEVESPI AEROSPHERE Drug Profile

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Which patents cover Bevespi Aerosphere, and what generic alternatives are available?

Bevespi Aerosphere is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and ten patent family members in twenty-seven countries.

The generic ingredient in BEVESPI AEROSPHERE is formoterol fumarate; glycopyrrolate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate; glycopyrrolate profile page.

Summary for BEVESPI AEROSPHERE

International Patents:	110
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BEVESPI AEROSPHERE
DailyMed Link:	BEVESPI AEROSPHERE at DailyMed

Generic Entry Opportunity Date for BEVESPI AEROSPHERE

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

208294

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 BEVESPI AEROSPHERE

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

US Patents and Regulatory Information for BEVESPI AEROSPHERE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Pharms	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes
Astrazeneca Pharms	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes
Astrazeneca Pharms	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes			Y
Astrazeneca Pharms	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes

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International Patents for BEVESPI AEROSPHERE

Country	Document Number	Estimated Expiration
Ukraine	109529
Australia	2010253950
South Africa	201208102
Poland	2435023

Supplementary Protection Certificates for BEVESPI AEROSPHERE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/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
02C/022	Belgium		PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825