Nayzilam is a drug owned by Ucb Inc. It is protected by 4 US drug patents filed in 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 18, 2028. Details of Nayzilam'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). | |||
| US9289432 | Methods and compositions for the delivery of a therapeutic agent |
Jan, 2028
(1 year, 3 months from now) | Active |
| US8217033 | Methods and compositions for the delivery of a therapeutic agent |
Jan, 2028
(1 year, 3 months from now) | Active |
| US9687495 | Methods and systems for the delivery of a therapeutic agent |
Jan, 2028
(1 year, 3 months from now) | Active |
| US8809322 | Methods and compositions for the delivery of a therapeutic agent |
Jan, 2028
(1 year, 3 months 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 Nayzilam's patents.
Latest Legal Activities on Nayzilam's Patents
Given below is the list of recent legal activities going on the following patents of Nayzilam.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 04 Feb, 2026 | US8809322 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Dec, 2024 | US9687495 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Dec, 2023 | US8217033 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Sep, 2023 | US9289432 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Feb, 2022 | US8809322 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Dec, 2020 | US9687495 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Dec, 2019 | US8217033 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Sep, 2019 | US9289432 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Feb, 2018 | US8809322 |
| Patent Issue Date Used in PTA Calculation
Critical | 27 Jun, 2017 | US9687495 |
FDA has granted several exclusivities to Nayzilam. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Nayzilam, 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
Nayzilam.
Exclusivity Information
Nayzilam holds 2 exclusivities. All of its exclusivities have expired in 2026. Details of Nayzilam's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 21, 2022 |
| Orphan Drug Exclusivity(ODE-243) | May 17, 2026 |
US patents provide insights into the exclusivity only within the United States, but
Nayzilam 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 Nayzilam's family patents as well as insights into
ongoing legal events
on those patents.
Nayzilam's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Nayzilam:
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:
Nayzilam's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 18, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nayzilam Generic API suppliers:
Midazolam is the generic name for the brand Nayzilam. 3 different companies have already filed for the generic of Nayzilam, with B Braun Medical having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nayzilam's generic
How can I launch a generic of Nayzilam before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nayzilam's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nayzilam'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 Nayzilam -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 01 Jun, 2021 | 18 Jan, 2028 | Less |
Alternative Brands for Nayzilam
Nayzilam which is used for managing acute seizure clusters in patients with epilepsy aged 12 years and above., has several other brand drugs using the same active ingredient (Midazolam). 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 |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Midazolam, Nayzilam's active ingredient. Check the complete list of approved generic manufacturers for Nayzilam
About Nayzilam
Nayzilam is a drug owned by Ucb Inc. It is used for managing acute seizure clusters in patients with epilepsy aged 12 years and above. Nayzilam uses Midazolam as an active ingredient. Nayzilam was launched by Ucb in 2019.
Approval Date:
Nayzilam was approved by FDA for market use on 17 May, 2019.
Active Ingredient:
Nayzilam uses Midazolam as the active ingredient. Check out other Drugs and Companies using Midazolam ingredient
Treatment:
Nayzilam is used for managing acute seizure clusters in patients with epilepsy aged 12 years and above.
Dosage:
Nayzilam is available in spray form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG/SPRAY | SPRAY | Prescription | NASAL |