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Last Updated: July 13, 2020

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ALIQOPA Drug Profile


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US ANDA Litigation and Generic Entry Outlook for Aliqopa

Aliqopa will be eligible for patent challenges on September 14, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 29, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ALIQOPA
Drug patent expirations by year for ALIQOPA
Drug Prices for ALIQOPA

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Generic Entry Opportunity Date for ALIQOPA
Generic Entry Date for ALIQOPA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS

*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 ALIQOPA

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

SponsorPhase
BayerPhase 1/Phase 2
The Miriam HospitalPhase 1/Phase 2
Clovis Oncology, Inc.Phase 1/Phase 2

See all ALIQOPA clinical trials

Pharmacology for ALIQOPA
Drug ClassKinase Inhibitor
Mechanism of ActionKinase Inhibitors

US Patents and Regulatory Information for ALIQOPA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare ALIQOPA copanlisib dihydrochloride POWDER;INTRAVENOUS 209936-001 Sep 14, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Healthcare ALIQOPA copanlisib dihydrochloride POWDER;INTRAVENOUS 209936-001 Sep 14, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Bayer Healthcare ALIQOPA copanlisib dihydrochloride POWDER;INTRAVENOUS 209936-001 Sep 14, 2017 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

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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Express Scripts
Baxter
Colorcon
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.