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Last Updated: November 4, 2024

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ADASUVE Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Adasuve

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

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Drug patent expirations by year for ADASUVE
Drug Prices for ADASUVE

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Recent Clinical Trials for ADASUVE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Lee's Pharmaceutical LimitedPhase 3
University of ArkansasPhase 4
Mount Sinai Hospital, ChicagoPhase 4

See all ADASUVE clinical trials

US Patents and Regulatory Information for ADASUVE

ADASUVE is protected by five US patents.

Patents protecting ADASUVE

Method and apparatus for vaporizing a compound
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Method of forming an aerosol for inhalation delivery
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Self-contained heating unit and drug-supply unit employing same
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Self-contained heating unit and drug-supply unit employing same
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Self-contained heating unit and drug-supply unit employing same
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ADASUVE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Sign Up ⤷  Sign Up
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Sign Up ⤷  Sign Up
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ADASUVE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Ferrer Internacional S.A. Adasuve loxapine EMEA/H/C/002400
Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.
Authorised no no no 2013-02-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ADASUVE

See the table below for patents covering ADASUVE around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1625333 UNITE DE CHAUFFAGE AUTONOME ET UNITE DE FOURNITURE DE MEDICAMENT FAISANT APPEL A CETTE UNITE DE CHAUFFAGE (SELF-CONTAINED HEATING UNIT AND DRUG-SUPPLY UNIT EMPLOYING SAME) ⤷  Sign Up
Poland 374048 UrzÄ…dzenie do tworzenia aerozolu do stosowania w terapii inhalacyjnej (AN AEROSOL FORMING DEVICE FOR USE IN INHALATION THERAPY) ⤷  Sign Up
European Patent Office 1390021 ADMINISTRATION PAR VOIE PULMONAIRE DE COMPOSES DESTINES AU TRAITEMENT DE LA MIGRAINE (DELIVERY OF COMPOUNDS FOR THE TREATMENT OF MIGRAINE THROUGH AN INHALATION ROUTE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ADASUVE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1389098 2013C/054 Belgium ⤷  Sign Up PRODUCT NAME: LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225
1389098 C300609 Netherlands ⤷  Sign Up PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098 300609 Netherlands ⤷  Sign Up PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.