.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021912

« Back to Dashboard
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 twelve 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 three drug master file entries for this compound. One supplier is listed for this compound. There is one tentative approval for this compound. Additional details are available on the arformoterol tartrate profile page.

Summary for NDA: 021912

Tradename:
BROVANA
Applicant:
Sunovion
Ingredient:
arformoterol tartrate
Patents:12
Therapeutic Class:Respiratory Tract Agents

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.015MG BASE/2ML
Approval Date:Oct 6, 2006TE:RLD:Yes
Patent:6,040,344Patent Expiration:Nov 12, 2016Product Flag?Substance Flag?YDelist Request?
Patent:6,472,563Patent Expiration:Nov 9, 2021Product Flag?Substance Flag?YDelist Request?
Patent:6,667,344Patent Expiration:Jun 22, 2021Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021912

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 20065,795,564► subscribe
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 20066,866,839► subscribe
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 20066,589,508► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc