Midazolam In 0.9% Sodium Chloride is a drug owned by Inforlife Sa. It is protected by 1 US drug patent filed in 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 20, 2038. Details of Midazolam In 0.9% Sodium Chloride'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). | |||
| US10966990 | Midazolam in flexible bags |
Jun, 2038
(11 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 Midazolam In 0.9% Sodium Chloride's patents.
Latest Legal Activities on Midazolam In 0.9% Sodium Chloride's Patents
Given below is the list of recent legal activities going on the following patents of Midazolam In 0.9% Sodium Chloride.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 18 Sep, 2024 | US10966990 |
| Patent Issue Date Used in PTA Calculation
Critical | 06 Apr, 2021 | US10966990 |
| Recordation of Patent Grant Mailed
Critical | 06 Apr, 2021 | US10966990 |
| Email Notification
Critical | 18 Mar, 2021 | US10966990 |
| Issue Notification Mailed
Critical | 17 Mar, 2021 | US10966990 |
| Application Is Considered Ready for Issue
Critical | 08 Mar, 2021 | US10966990 |
| Dispatch to FDC | 08 Mar, 2021 | US10966990 |
| Issue Fee Payment Verified
Critical | 03 Mar, 2021 | US10966990 |
| Issue Fee Payment Received
Critical | 03 Mar, 2021 | US10966990 |
| Email Notification
Critical | 09 Feb, 2021 | US10966990 |
US patents provide insights into the exclusivity only within the United States, but
Midazolam In 0.9% Sodium Chloride 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 Midazolam In 0.9% Sodium Chloride's family patents as well as insights into
ongoing legal events
on those patents.
Midazolam In 0.9% Sodium Chloride's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Midazolam In 0.9% Sodium Chloride:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Midazolam In 0.9% Sodium Chloride's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 20, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Midazolam In 0.9% Sodium Chloride Generic API suppliers:
Midazolam is the generic name for the brand Midazolam In 0.9% Sodium Chloride. 3 different companies have already filed for the generic of Midazolam In 0.9% Sodium Chloride, with B Braun Medical having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Midazolam In 0.9% Sodium Chloride's generic
How can I launch a generic of Midazolam In 0.9% Sodium Chloride before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Midazolam In 0.9% Sodium Chloride's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Midazolam In 0.9% Sodium Chloride'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 Midazolam In 0.9% Sodium Chloride -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 29 Sep, 2021 | 20 Jun, 2038 | Eligible | 17 Apr, 2023 | Less |
Alternative Brands for Midazolam In 0.9% Sodium Chloride
There are several other brand drugs using the same active ingredient (Midazolam) as Midazolam In 0.9% Sodium Chloride. 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 | |
|---|---|---|
| Ucb Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Midazolam, Midazolam In 0.9% Sodium Chloride's active ingredient. Check the complete list of approved generic manufacturers for Midazolam In 0.9% Sodium Chloride
About Midazolam In 0.9% Sodium Chloride
Midazolam In 0.9% Sodium Chloride is a drug owned by Inforlife Sa. Midazolam In 0.9% Sodium Chloride uses Midazolam as an active ingredient. Midazolam In 0.9% Sodium Chloride was launched by Inforlife in 2021.
Approval Date:
Midazolam In 0.9% Sodium Chloride was approved by FDA for market use on 22 March, 2021.
Active Ingredient:
Midazolam In 0.9% Sodium Chloride uses Midazolam as the active ingredient. Check out other Drugs and Companies using Midazolam ingredient
Dosage:
Midazolam In 0.9% Sodium Chloride is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/100ML (1MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 50MG/50ML (1MG/ML) | SOLUTION | Prescription | INTRAVENOUS |