Giapreza Patent Expiration

Giapreza is a drug owned by La Jolla Pharma Llc. It is protected by 11 US drug patents filed from 2018 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 06, 2037. Details of Giapreza's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10548943 Method of treating low blood pressure
Dec, 2029

(5 years from now)

Active
US10335451 Method of treating low blood pressure
Dec, 2029

(5 years from now)

Active
US10500247 Method of treating low blood pressure
Dec, 2029

(5 years from now)

Active
US9867863 Method of treating low blood pressure
Dec, 2029

(5 years from now)

Active
US9572856 Method of treating low blood pressure
Jul, 2031

(7 years from now)

Active
US10028995 Angiotensin II alone or in combination for the treatment of hypotension
Dec, 2034

(10 years from now)

Active
US11559559 Angiotensin II alone or in combination for the treatment of hypotension
Dec, 2034

(10 years from now)

Active
US11096983 Angiotensin II alone or in combination for the treatment of hypotension
Dec, 2034

(10 years from now)

Active
US10493124 Angiotensin II alone or in combination for the treatment of hypotension
Dec, 2034

(10 years from now)

Active
US9220745 Angiotensin II alone or in combination for the treatment of hypotension
Dec, 2034

(10 years from now)

Active
US11219662 Methods for treating hypotension in a patient that has received an ACE inhibitor by administering angiotensin II
Jan, 2037

(12 years from now)

Active


FDA has granted several exclusivities to Giapreza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Giapreza, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Giapreza.

Exclusivity Information

Giapreza holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Giapreza's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 21, 2022

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US patents provide insights into the exclusivity only within the United States, but Giapreza is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Giapreza's family patents as well as insights into ongoing legal events on those patents.

Giapreza's family patents

Giapreza has patent protection in a total of 23 countries. It's US patent count contributes only to 37.7% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Giapreza.

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Generic Launch

Generic Release Date:

Giapreza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 06, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Giapreza Generics:

There are no approved generic versions for Giapreza as of now.

How can I launch a generic of Giapreza before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Giapreza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Giapreza's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Giapreza -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
2.5 mg/mL 21 Dec, 2021 1 18 Dec, 2034




About Giapreza

Giapreza is a drug owned by La Jolla Pharma Llc. It is used for increasing blood pressure and treating shock, especially in patients unresponsive to other vasopressors. Giapreza uses Angiotensin Ii Acetate as an active ingredient. Giapreza was launched by La Jolla Pharma in 2021.

Market Authorisation Date:

Giapreza was approved by FDA for market use on 23 December, 2021.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Giapreza is 23 December, 2021, its NCE-1 date is estimated to be 21 December, 2021

Active Ingredient:

Giapreza uses Angiotensin Ii Acetate as the active ingredient. Check out other Drugs and Companies using Angiotensin Ii Acetate ingredient

Treatment:

Giapreza is used for increasing blood pressure and treating shock, especially in patients unresponsive to other vasopressors.

Dosage:

Giapreza is available in solution form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) SOLUTION Prescription INTRAVENOUS
EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION Prescription INTRAVENOUS
EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) SOLUTION Discontinued INTRAVENOUS