DrugPatentWatch Database Preview
Email this page to a colleague
« Back to Dashboard
Adasuve is a drug marketed by Alexza Pharms and is included in one NDA. There are eighteen patents protecting this drug.
This drug has two hundred and twenty-seven patent family members in twenty-one countries.
The generic ingredient in ADASUVE is loxapine. There are eight drug master file entries for this compound. Additional details are available on the loxapine profile page.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 26, 2021. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for ADASUVE
|Raw Ingredient (Bulk) Api Vendors:||34|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price information for ADASUVE|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for ADASUVE|
|What excipients (inactive ingredients) are in ADASUVE?||ADASUVE excipients list|
|DailyMed Link:||ADASUVE at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for ADASUVE
*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.
Recent Clinical Trials for ADASUVE
Identify potential brand extensions & 505(b)(2) entrants
|Lee's Pharmaceutical Limited||Phase 3|
|Advocate Health Care||N/A|
|Teva Branded Pharmaceutical Products, R&D Inc.||Phase 1|
|Country||Patent Number||Estimated Expiration|
|European Patent Office||1392264||⤷ Free Forever Trial|
|Japan||2004532860||⤷ Free Forever Trial|
|World Intellectual Property Organization (WIPO)||02098389||⤷ Free Forever Trial|
|Canada||2460343||⤷ Free Forever Trial|
|Poland||363996||⤷ Free Forever Trial|
|Spain||2623467||⤷ Free Forever Trial|
|European Patent Office||1392381||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1389098||132013902184784||Italy||⤷ Free Forever Trial||PRODUCT NAME: LOXAPINA(ADASUVE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/823/001-002, 20130220|
|1389098||SPC/GB13/055||United Kingdom||⤷ Free Forever Trial||PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220|
|1389098||CA 2013 00046||Denmark||⤷ Free Forever Trial||PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220|
|1389098||473||Finland||⤷ Free Forever Trial|
|1389098||2013C/054||Belgium||⤷ Free Forever Trial||PRODUCT NAME: ADASUVE-LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225|
|1389098||CR 2013 00046||Denmark||⤷ Free Forever Trial||PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220|
|1389098||1390040-2||Sweden||⤷ Free Forever Trial||PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001 20130220|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|