Last Updated: July 28, 2026

BREYNA Drug Patent Profile

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Which patents cover Breyna, and when can generic versions of Breyna launch?

Breyna is a drug marketed by Mylan and is included in one NDA.

The generic ingredient in BREYNA is budesonide; formoterol fumarate dihydrate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the budesonide; formoterol fumarate dihydrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Breyna

A generic version of BREYNA was approved as budesonide; formoterol fumarate dihydrate by TEVA PHARMS USA INC on April 23^rd, 2026.

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Summary for BREYNA

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for BREYNA

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	BREYNA	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	211699-001	Mar 15, 2022	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Mylan	BREYNA	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	211699-002	Mar 15, 2022	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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