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Last Updated: November 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207930

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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 eighteen 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. One supplier is 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:18
Generic Entry Opportunity Date for 207930
Generic Entry Date for 207930*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;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: 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 Sunovion Pharmaceuticals Inc. 63402-681 63402-681-06 1 BLISTER PACK in 1 CARTON (63402-681-06) > 6 CAPSULE in 1 BLISTER PACK (63402-681-01) > 1 CAPSULE in 1 CAPSULE
UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930 NDA Sunovion Pharmaceuticals Inc. 63402-681 63402-681-12 2 BLISTER PACK in 1 CARTON (63402-681-12) > 6 CAPSULE in 1 BLISTER PACK (63402-681-02) > 1 CAPSULE in 1 CAPSULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength15.6MCG/INH;27.5MCG/INH
Approval Date:Oct 29, 2015TE:RLD:Yes
Patent:  Start 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:  Start 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)
Patent:  Start TrialPatent Expiration:Jun 27, 2021Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 207930

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015   Start Trial   Start Trial
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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