BROVANA Drug Patent Profile

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

Brovana is a drug marketed by Lupin and is included in one NDA.

The generic ingredient in BROVANA is arformoterol tartrate. There are four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the arformoterol tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Brovana

A generic version of BROVANA was approved as arformoterol tartrate by CIPLA on June 22^nd, 2021.

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Summary for BROVANA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	16
Patent Applications:	117
Drug Prices:	Drug price information for BROVANA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BROVANA
What excipients (inactive ingredients) are in BROVANA?	BROVANA excipients list
DailyMed Link:	BROVANA at DailyMed

Drug patent expirations by year for BROVANA

Recent Clinical Trials for BROVANA

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
Dartmouth-Hitchcock Medical Center	N/A
Sunovion	N/A

See all BROVANA clinical trials

Pharmacology for BROVANA

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

Paragraph IV (Patent) Challenges for BROVANA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BROVANA	Inhalation Solution	arformoterol tartrate	Eq. 0.015 mg base/ 2 mL	021912	1	2009-10-01

US Patents and Regulatory Information for BROVANA

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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
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	AN	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for BROVANA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for BROVANA

See the table below for patents covering BROVANA around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2002244211		⤷ Sign Up
Netherlands	195084		⤷ Sign Up
Canada	2477642	PROCEDE D'ELABORATION DE FORMOTEROL TARTRATE ET POLYMORPHE (FORMOTEROL TARTRATE PROCESS AND POLYMORPH)	⤷ Sign Up
Italy	RM920237		⤷ Sign Up
Japan	2015178506	霧状化を経て肺に送達するためのフォルモテロール含有エアゾール組成物 (AEROSOL COMPOSITIONS CONTAINING FORMOTEROL FOR DELIVERY TO LUNGS VIA NEBULIZATION)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration