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Last Updated: May 26, 2022

GIAPREZA Drug Patent 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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in twenty-one 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.

DrugPatentWatch® Generic Entry Outlook for Giapreza

Giapreza was eligible for patent challenges on December 21, 2021.

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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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

See drug prices for GIAPREZA

DrugPatentWatch® Estimated 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
National Center for Advancing Translational Science (NCATS)Phase 4
University of New MexicoPhase 4
University of California, Los AngelesPhase 2

See all GIAPREZA clinical trials

Paragraph IV (Patent) Challenges for GIAPREZA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GIAPREZA Injection angiotensin ii acetate 2.5 mg/mL 209360 1 2021-12-21

US Patents and Regulatory Information for GIAPREZA

GIAPREZA is protected by fifteen US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GIAPREZA is See Plans and Pricing.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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 GIAPREZA

Angiotensin II alone or in combination for the treatment of hypotension
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR ABOVE WITH ABOUT 1 NG/KG/MIN TO ABOUT 40 NG/KG/MIN ANGIOTENSIN II IN HYPOTENSIVE PATIENTS TREATED WITH VASOPRESSIN OR A VASOPRESSIN ANALOGUE AND REDUCING VASOPRESSIN OR VASOPRESSIN ANALOGUE USE

Method of treating low blood pressure
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING HYPOTENSION WITH ABOUT 20 NG/KG/MIN TO ABOUT 40 NG/KG/MIN ANGIOTENSIN II IN A HUMAN SUBJECT HAVING SEPTIC SHOCK

Angiotensin II alone or in combination for the treatment of hypotension
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING LOW BLOOD PRESSURE WITH ANGIOTENSIN II AT AN INITIAL RATE OF ABOUT 20 NG/KG/MIN AND TITRATING DOWN TO ACHIEVE AND/OR MAINTAIN A MAP OF ABOUT 65 MM HG OR ABOVE

Method of treating low blood pressure
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING LOW BLOOD PRESSURE WITH ANGIOTENSIN II WITH AN INITIAL RATE OF ABOUT 5 NG/KG/MIN TO ABOUT 20 NG/KG/MIN IN A SUBJECT HAVING REFRACTORY HYPOTENSION OR SEVERE HYPOTENSION, AND TITRATING THE RATE UP

Method of treating low blood pressure
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING LOW BLOOD PRESSURE WITH ANGIOTENSIN II WITH AN INITIAL RATE OF ABOUT 5 NG/KG/MIN TO ABOUT 20 NG/KG/MIN IN A SUBJECT HAVING REFRACTORY HYPOTENSION OR SEVERE HYPOTENSION

Method of treating low blood pressure
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INCREASING BLOOD PRESSURE WITH A RATE OF ABOUT 20 NG/KG/MIN TO ABOUT 40 NG/KG/MIN ANGIOTENSIN II IN A HUMAN SUBJECT HAVING SEPTIC SHOCK

Method of treating low blood pressure
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INCREASING BLOOD PRESSURE WITH AN INITIAL RATE OF ABOUT 20 NG/KG/MIN ANGIOTENSIN II IN A HUMAN SUBJECT HAVING SEPTIC SHOCK, AND TITRATING THE RATE UP.

Angiotensin II alone or in combination for the treatment of hypotension
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING SEPTIC SHOCK WITH ANGIOTENSIN II

Angiotensin II alone or in combination for the treatment of hypotension
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING DISTRIBUTIVE SHOCK WITH ANGIOTENSIN II


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING HYPOTENSION WITH ANGIOTENSIN II IN A PATIENT RECEIVING AN ANGIOTENSIN CONVERTING ENZYME INHIBITOR

Angiotensin II alone or in combination for the treatment of hypotension
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING HIGH OUTPUT SHOCK WITH ANGIOTENSIN II BY INCREASING MEAN ARTERIAL PRESSURE IN PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE

Angiotensin II alone or in combination for the treatment of hypotension
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR HIGHER WITH ANGIOTENSIN II IN SHOCK PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE

Method of treating low blood pressure
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING REFRACTORY HYPOTENSION WITH ABOUT 20 NG/KG/MIN ANGIOTENSIN II IN A PATIENT RECEIVING VASOPRESSOR

Method of treating low blood pressure
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING REFRACTORY HYPOTENSION WITH ABOUT 20 NG/KG/MIN ANGIOTENSIN II IN A PATIENT RECEIVING VASOPRESSOR

Method of treating low blood pressure
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING REFRACTORY HYPOTENSION WITH ABOUT 5 NG/KG/MIN TO ABOUT 20 NG/KG/MIN ANGIOTENSIN II IN A PATIENT RECEIVING VASOPRESSOR

FDA Regulatory Exclusivity protecting GIAPREZA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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

International Patents for GIAPREZA

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

Country Patent Number Title Estimated Expiration
South Korea 20160117437 저혈압의 치료를 위한 안지오텐신 II 단독 또는 조합 (II ANGIOTENSIN II ALONE OR IN COMBINATION FOR THE TREATMENT OF HYPOTENSION) See Plans and Pricing
European Patent Office 3607962 ANGIOTENSINE II SEULE OU EN ASSOCIATION POUR LE TRAITEMENT DE L'HYPOTENSION (ANGIOTENSIN II ALONE OR IN COMBINATION FOR THE TREATMENT OF HYPOTENSION) See Plans and Pricing
Japan 6824739 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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.