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Last Updated: October 2, 2023

ADASUVE Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Adasuve

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 20, 2024. 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

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Drug patent expirations by year for ADASUVE
Drug Prices for ADASUVE

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ADASUVE
Generic Entry Date for ADASUVE*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for ADASUVE

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

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

See all ADASUVE clinical trials

US Patents and Regulatory Information for ADASUVE

ADASUVE is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ADASUVE is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ADASUVE

Method and apparatus for vaporizing a compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method of forming an aerosol for inhalation delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Self-contained heating unit and drug-supply unit employing same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Self-contained heating unit and drug-supply unit employing same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Self-contained heating unit and drug-supply unit employing same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Try a Trial ⤷  Try a Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Try a Trial ⤷  Try a Trial
>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
World Intellectual Property Organization (WIPO) 02094238 ⤷  Try a Trial
China 1512900 用于吸入疗法的气溶胶的形成设备 (Aerosol forming device for use in inhalation therapy) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2004104491 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ADASUVE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1389098 CA 2013 00046 Denmark ⤷  Try a Trial PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
1389098 132013902184784 Italy ⤷  Try a Trial PRODUCT NAME: LOXAPINA(ADASUVE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/823/001-002, 20130220
1389098 2013C/054 Belgium ⤷  Try a Trial PRODUCT NAME: LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Harvard Business School
McKesson
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Dow

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.