Norepinephrine Bitartrate In 5% Dextrose is a drug owned by Baxter Healthcare Corp. It is protected by 2 US drug patents filed from 2024 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 08, 2041. Details of Norepinephrine Bitartrate In 5% Dextrose'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). | |||
| US12097170 | Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation |
Mar, 2041
(14 years from now) | Active |
| US12290494 | Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation |
Mar, 2041
(14 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 Norepinephrine Bitartrate In 5% Dextrose's patents.
Latest Legal Activities on Norepinephrine Bitartrate In 5% Dextrose's Patents
Given below is the list of recent legal activities going on the following patents of Norepinephrine Bitartrate In 5% Dextrose.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation | 06 May, 2025 | US12290494 |
| Recordation of Patent Grant Mailed | 06 May, 2025 | US12290494 |
| Mail Patent eGrant Notification | 06 May, 2025 | US12290494 |
| Patent eGrant Notification | 06 May, 2025 | US12290494 |
| Email Notification | 06 May, 2025 | US12290494 |
| Recordation of Patent eGrant | 06 May, 2025 | US12290494 |
| Email Notification | 17 Apr, 2025 | US12290494 |
| Issue Notification Mailed | 16 Apr, 2025 | US12290494 |
| Dispatch to FDC | 10 Apr, 2025 | US12290494 |
| Application Is Considered Ready for Issue | 10 Apr, 2025 | US12290494 |
US patents provide insights into the exclusivity only within the United States, but
Norepinephrine Bitartrate In 5% Dextrose 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 Norepinephrine Bitartrate In 5% Dextrose's family patents as well as insights into
ongoing legal events
on those patents.
Norepinephrine Bitartrate In 5% Dextrose's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Norepinephrine Bitartrate In 5% Dextrose's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 08, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Norepinephrine Bitartrate In 5% Dextrose Generic API suppliers:
Norepinephrine Bitartrate is the generic name for the brand Norepinephrine Bitartrate In 5% Dextrose. 19 different companies have already filed for the generic of Norepinephrine Bitartrate In 5% Dextrose, with Sagent having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Norepinephrine Bitartrate In 5% Dextrose's generic
How can I launch a generic of Norepinephrine Bitartrate In 5% Dextrose before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Norepinephrine Bitartrate In 5% Dextrose's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Norepinephrine Bitartrate In 5% Dextrose'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 Norepinephrine Bitartrate In 5% Dextrose -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 07 Oct, 2024 | 08 Mar, 2041 | Less |
Alternative Brands for Norepinephrine Bitartrate In 5% Dextrose
There are several other brand drugs using the same active ingredient (Norepinephrine Bitartrate) as Norepinephrine Bitartrate In 5% Dextrose. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Inforlife |
| |
| Long Grove Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Norepinephrine Bitartrate, Norepinephrine Bitartrate In 5% Dextrose's active ingredient. Check the complete list of approved generic manufacturers for Norepinephrine Bitartrate In 5% Dextrose
About Norepinephrine Bitartrate In 5% Dextrose
Norepinephrine Bitartrate In 5% Dextrose is a drug owned by Baxter Healthcare Corp. Norepinephrine Bitartrate In 5% Dextrose uses Norepinephrine Bitartrate as an active ingredient. Norepinephrine Bitartrate In 5% Dextrose was launched by Baxter in 2021.
Approval Date:
Norepinephrine Bitartrate In 5% Dextrose was approved by FDA for market use on 15 January, 2021.
Active Ingredient:
Norepinephrine Bitartrate In 5% Dextrose uses Norepinephrine Bitartrate as the active ingredient. Check out other Drugs and Companies using Norepinephrine Bitartrate ingredient
Dosage:
Norepinephrine Bitartrate In 5% Dextrose is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |
| EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |
| EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |