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Last Updated: August 13, 2020

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GIAPREZA Drug Profile

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Which patents cover Giapreza, and what generic alternatives are available?

Giapreza is a drug marketed by La Jolla Pharma and is included in one NDA. There are eight patents protecting this drug.

This drug has twenty-two patent family members in twenty countries.

The generic ingredient in GIAPREZA is angiotensin ii acetate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the angiotensin ii acetate profile page.

US ANDA Litigation and Generic Entry Outlook for Giapreza

Giapreza will be eligible for patent challenges on December 21, 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 December 21, 2022. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for GIAPREZA
Drug Prices for GIAPREZA

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Generic Entry Opportunity Date for GIAPREZA
Generic Entry Date for GIAPREZA*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
NDA:
Dosage:
SOLUTION;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 GIAPREZA

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

SponsorPhase
University of California, Los AngelesEarly Phase 1
La Jolla Pharmaceutical CompanyPhase 1
Wake Forest University Health SciencesPhase 1

See all GIAPREZA clinical trials

Pharmacology for GIAPREZA
Drug ClassVasoconstrictor
Physiological EffectVasoconstriction

US Patents and Regulatory Information for GIAPREZA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
La Jolla Pharma GIAPREZA angiotensin ii acetate SOLUTION;INTRAVENOUS 209360-001 Dec 21, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
La Jolla Pharma GIAPREZA angiotensin ii acetate SOLUTION;INTRAVENOUS 209360-002 Dec 21, 2017 DISCN Yes No   Start Trial   Start Trial   Start Trial
La Jolla Pharma GIAPREZA angiotensin ii acetate SOLUTION;INTRAVENOUS 209360-002 Dec 21, 2017 DISCN Yes No   Start Trial   Start Trial   Start Trial
La Jolla Pharma GIAPREZA angiotensin ii acetate SOLUTION;INTRAVENOUS 209360-001 Dec 21, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
La Jolla Pharma GIAPREZA angiotensin ii acetate SOLUTION;INTRAVENOUS 209360-001 Dec 21, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
La Jolla Pharma GIAPREZA angiotensin ii acetate SOLUTION;INTRAVENOUS 209360-001 Dec 21, 2017 RX Yes Yes   Start Trial   Start Trial   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:

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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.