BROVANA Drug Patent Profile

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. Ten 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.

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

See drug prices 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

Anatomical Therapeutic Chemical (ATC) Classes for BROVANA

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, 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

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

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

Expired US Patents for BROVANA

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

International Patents for BROVANA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0021487
Netherlands	9200629
Japan	2001503772
Australia	2008253696
France	2674751	UTILISATION AMELIOREE DE MEDICAMENTS BRONCHODILATATEURS BETA2-STIMULANTS.
Taiwan	200507830	Bronchodilating β -agonist compositions and methods
Denmark	1082293