.

Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

► See Plans & Pricing

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

Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
McKinsey
Harvard Business School
Healthtrust
Chubb
Cipla
Cantor Fitzgerald
US Army
Dow
Farmers Insurance

Generated: September 26, 2017

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 one supplier. 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 fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the glycopyrrolate ; indacaterol maleate profile page.

Summary for NDA: 207930

Tradename:
1
Applicant:
1
Ingredient:
1
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 0078-0664-06 6 CAPSULE in 1 BOX, UNIT-DOSE (0078-0664-06)
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION 207930 NDA Novartis Pharmaceuticals Corporation 0078-0664 0078-0664-19 60 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0664-19) > 1 CAPSULE in 1 BLISTER PACK (0078-0664-61)

Summary 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:Jul 1, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 29, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:► SubscribePatent 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)

Expired Orange Book Patents for NDA: 207930

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015► Subscribe► 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

Serving 500+ biopharmaceutical companies globally:

Novartis
McKinsey
AstraZeneca
Federal Trade Commission
Teva
Julphar
Covington
Chubb
Moodys
US Army

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot