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Last Updated: August 6, 2020

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ADASUVE Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Adasuve

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

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Drug patent expirations by year for ADASUVE
Drug Prices for ADASUVE

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Generic Entry Opportunity 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
Advocate Health CareN/A
Teva Branded Pharmaceutical Products, R&D Inc.Phase 1

See all ADASUVE clinical trials

US Patents and Regulatory Information for ADASUVE

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   Start Trial   Start Trial Y   Start Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ADASUVE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1389098 132013902184784 Italy   Start Trial PRODUCT NAME: LOXAPINA(ADASUVE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/823/001-002, 20130220
1389098 CA 2013 00046 Denmark   Start Trial PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
1389098 SPC/GB13/055 United Kingdom   Start Trial PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220
1389098 CR 2013 00046 Denmark   Start Trial PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
1389098 473 Finland   Start Trial
1389098 C300609 Netherlands   Start Trial 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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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.