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

Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Baxter
Dow
Federal Trade Commission
Cerilliant
Fuji
Fish and Richardson
Healthtrust
Cipla

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207930

« Back to Dashboard

NDA 207930 describes UTIBRON, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from two suppliers. There are sixteen patents protecting this drug. Additional details are available on the UTIBRON profile page.

The generic ingredient in UTIBRON is glycopyrrolate ; indacaterol maleate. There are seventeen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the glycopyrrolate ; indacaterol maleate profile page.
Summary for 207930
Tradename:UTIBRON
Applicant:Sunovion Pharms Inc
Ingredient:glycopyrrolate ; indacaterol maleate
Patents:16
Formulation / Manufacturing:see details
Pharmacology for NDA: 207930
Suppliers and Packaging for NDA: 207930
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930 NDA Novartis Pharmaceuticals Corporation 0078-0664 N 0078-0664-06
UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930 NDA Novartis Pharmaceuticals Corporation 0078-0664 N 0078-0664-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength15.6MCG/INH;27.5MCG/INH
Approval Date:Oct 29, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 29, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Feb 25, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:LONG - TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:➤ Try a Free TrialPatent Expiration:Apr 9, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:LONG - TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Fish and Richardson
Accenture
Covington
Moodys
McKesson
UBS
Farmers Insurance
Mallinckrodt

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.