Last Updated: August 3, 2026

Details for New Drug Application (NDA): 022549

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NDA 022549 describes ADASUVE, which is a drug marketed by Nova Pneuma and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ADASUVE profile page.

The generic ingredient in ADASUVE is loxapine. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the loxapine profile page.

Summary for 022549

Tradename:	ADASUVE
Applicant:	Nova Pneuma
Ingredient:	loxapine
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022549

Generic Entry Date for 022549^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial 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.

Medical Subject Heading (MeSH) Categories for 022549

Antipsychotic Agents
Dopamine Antagonists

Suppliers and Packaging for NDA: 022549

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADASUVE	loxapine	POWDER;INHALATION	022549	NDA	Alexza Pharmaceuticals, Inc.	51097-001	51097-001-02	5 INHALER in 1 CARTON (51097-001-02) / 1 AEROSOL, POWDER in 1 INHALER (51097-001-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INHALATION			Strength	10MG
Approval Date:	Dec 21, 2012	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Oct 23, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022549

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Nova Pneuma	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	⤷ Start Trial	⤷ Start Trial
Nova Pneuma	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	⤷ Start Trial	⤷ Start Trial
Nova Pneuma	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	⤷ Start Trial	⤷ Start Trial
Nova Pneuma	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	⤷ Start Trial	⤷ Start Trial
Nova Pneuma	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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