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Generated: November 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021912

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NDA 021912 describes BROVANA, which is a drug marketed by Sunovion and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BROVANA profile page.

The generic ingredient in BROVANA is arformoterol tartrate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the arformoterol tartrate profile page.
Summary for 021912
Tradename:BROVANA
Applicant:Sunovion
Ingredient:arformoterol tartrate
Patents:11
Generic Entry Opportunity Date for 021912
Generic Entry Date for 021912*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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 NDA: 021912
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 021912
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BROVANA arformoterol tartrate SOLUTION;INHALATION 021912 NDA Sunovion Pharmaceuticals Inc. 63402-911 63402-911-08 2 POUCH in 1 CARTON (63402-911-08) > 4 VIAL, SINGLE-DOSE in 1 POUCH (63402-911-03) > 2 mL in 1 VIAL, SINGLE-DOSE
BROVANA arformoterol tartrate SOLUTION;INHALATION 021912 NDA Sunovion Pharmaceuticals Inc. 63402-911 63402-911-30 30 POUCH in 1 CARTON (63402-911-30) > 1 VIAL, SINGLE-DOSE in 1 POUCH (63402-911-01) > 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.015MG BASE/2ML
Approval Date:Oct 6, 2006TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 9, 2021Product Flag?Substance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jun 22, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Nov 9, 2021Product Flag?Substance Flag?YDelist Request?

Expired US Patents for NDA 021912

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Dow
McKesson
Healthtrust
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Deloitte
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US Department of Justice
Argus Health

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