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. Giapreza's patents have been open to challenges since 21 December, 2021. 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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| 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 |
| US11559559 | Angiotensin II alone or in combination for the treatment of hypotension |
Dec, 2034
(9 years from now) | Active |
| US11096983 | Angiotensin II alone or in combination for the treatment of hypotension |
Dec, 2034
(9 years from now) | Active |
| US10028995 | Angiotensin II alone or in combination for the treatment of hypotension |
Dec, 2034
(9 years from now) | Active |
| US10493124 | Angiotensin II alone or in combination for the treatment of hypotension |
Dec, 2034
(9 years from now) | Active |
| US9220745 | Angiotensin II alone or in combination for the treatment of hypotension |
Dec, 2034
(9 years from now) | Active |
| US9572856 | Method of treating low blood pressure |
Nov, 2030
(5 years from now) | Active |
| US9867863 | Method of treating low blood pressure |
Dec, 2029
(4 years from now) | Active |
| US10335451 | Method of treating low blood pressure |
Dec, 2029
(4 years from now) | Active |
| US10548943 | Method of treating low blood pressure |
Dec, 2029
(4 years from now) | Active |
| US10500247 | Method of treating low blood pressure |
Dec, 2029
(4 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Giapreza's patents.
Latest Legal Activities on Giapreza's Patents
Given below is the list of recent legal activities going on the following patents of Giapreza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 04 Aug, 2023 | US10548943 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Jun, 2023 | US9220745 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Jun, 2023 | US10500247 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Jun, 2023 | US10493124 |
| Sequence Moved to Public Database | 24 Jan, 2023 | US11559559 |
| Recordation of Patent Grant Mailed Critical | 24 Jan, 2023 | US11559559 |
| Patent Issue Date Used in PTA Calculation Critical | 24 Jan, 2023 | US11559559 |
| Email Notification Critical | 05 Jan, 2023 | US11559559 |
| Issue Notification Mailed Critical | 04 Jan, 2023 | US11559559 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Jan, 2023 | US10335451 |
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 |
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
Explore Our Curated Drug Screens
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.
Approval Date:
Giapreza was approved by FDA for market use on 23 December, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 2.5MG BASE/ML (EQ 2.5MG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |
| EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) | SOLUTION | Discontinued | INTRAVENOUS |
| EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |