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Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022549

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NDA 022549 describes ADASUVE, which is a drug marketed by Galen Uk and is included in one NDA. It is available from two suppliers. There are eighteen patents 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. Two suppliers are listed for this compound. Additional details are available on the loxapine profile page.
Summary for 022549
Tradename:ADASUVE
Applicant:Galen Uk
Ingredient:loxapine
Patents:18
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022549
Generic Entry Date for 022549*:
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.

Medical Subject Heading (MeSH) Categories for 022549
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 Galen US Incorporated 10885-003 10885-003-05 5 POUCH in 1 CARTON (10885-003-05) > 1 AEROSOL, POWDER in 1 POUCH (10885-003-01)
ADASUVE loxapine POWDER;INHALATION 022549 NDA Teva Select Brands 57844-510 57844-510-55 5 POUCH in 1 CARTON (57844-510-55) > 1 AEROSOL, POWDER in 1 POUCH (57844-510-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength10MG
Approval Date:Dec 21, 2012TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:May 20, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Oct 26, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Oct 26, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:ADASUVE IS A TYPICAL ANTIPSYCHOTIC INDICATED FOR THE ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I DISORDER IN ADULTS

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Cerilliant
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