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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 207930

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NDA 207930 describes UTIBRON, which is a drug marketed by Novartis and is included in one NDA. There are three 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. Additional details are available on the glycopyrrolate; indacaterol maleate profile page.

Summary for 207930

Tradename:	UTIBRON
Applicant:	Novartis
Ingredient:	glycopyrrolate; indacaterol maleate
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 207930

Generic Entry Date for 207930^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 8,479,730 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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INHALATION			Strength	15.6MCG/INH;27.5MCG/INH
Approval Date:	Oct 29, 2015	TE:		RLD:	Yes
Patent:	6,878,721	Patent Expiration:	Feb 25, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:	8,182,838	Patent Expiration:	Oct 20, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,479,730	Patent Expiration:	Oct 11, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 207930

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	8,048,451	⤷ Subscribe
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	9,931,304	⤷ Subscribe
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	6,521,260	⤷ Subscribe
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	8,435,567	⤷ Subscribe
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	8,303,991	⤷ Subscribe
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	8,956,661	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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 verification 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.