Details for New Drug Application (NDA): 208437

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NDA 208437 describes LONHALA MAGNAIR KIT, which is a drug marketed by Sumitomo Pharma Am and is included in one NDA. There are eleven patents protecting this drug. Additional details are available on the LONHALA MAGNAIR KIT profile page.

The generic ingredient in LONHALA MAGNAIR KIT is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 208437

Tradename:	LONHALA MAGNAIR KIT
Applicant:	Sumitomo Pharma Am
Ingredient:	glycopyrrolate
Patents:	11

Medical Subject Heading (MeSH) Categories for 208437

Adjuvants, Anesthesia
Muscarinic Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION			Strength	25MCG/ML
Approval Date:	Dec 5, 2017	TE:		RLD:	Yes
Patent:	10,376,661	Patent Expiration:	Sep 14, 2035	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,688,518	Patent Expiration:	Nov 12, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,744,277	Patent Expiration:	Dec 7, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	A METHOD OF USING AN AEROSOL DELIVERY DEVICE TO AEROSOLIZE GLYCOPYRROLATE FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Expired US Patents for NDA 208437

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017	6,962,151	⤷ Subscribe
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017	8,511,581	⤷ Subscribe
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017	7,458,372	⤷ Subscribe
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017	7,316,067	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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