Nymalize is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 10 US drug patents filed from 2020 to 2025. Out of these, 8 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 16, 2038. Details of Nymalize'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). | |||
| US11806338 | Non-aqueous liquid nimodipine compositions |
Apr, 2038
(12 years from now) | Active |
| US11207306 | Non-aqueous liquid nimodipine compositions |
Apr, 2038
(12 years from now) | Active |
| US11517563 | Liquid nimodipine compositions |
Apr, 2038
(12 years from now) | Active |
| US11759457 | Liquid nimodipine compositions |
Apr, 2038
(12 years from now) | Active |
| US12186308 | Non-aqueous liquid nimodipine compositions |
Apr, 2038
(12 years from now) | Active |
| US11413277 | Non-aqueous liquid nimodipine compositions |
Apr, 2038
(12 years from now) | Active |
| US10342787 | Non-aqueous liquid nimodipine compositions |
Apr, 2038
(12 years from now) | Active |
| US10576070 | Non-aqueous liquid nimodipine compositions |
Apr, 2038
(12 years from now) | Active |
| US8517997 | Dispenser for medicaments and method and apparatus for making same |
May, 2024
(1 year, 5 months ago) |
Expired
|
| US7070581 | Dispenser for medicaments and method and apparatus for making same |
Jun, 2023
(2 years ago) |
Expired
|
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 Nymalize's patents.
Latest Legal Activities on Nymalize's Patents
Given below is the list of recent legal activities going on the following patents of Nymalize.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent eGrant Notification | 07 Nov, 2023 | US11806338 |
| Recordation of Patent eGrant | 07 Nov, 2023 | US11806338 |
| Recordation of Patent Grant Mailed
Critical | 07 Nov, 2023 | US11806338 |
| Patent Issue Date Used in PTA Calculation
Critical | 07 Nov, 2023 | US11806338 |
| Mail Patent eGrant Notification | 07 Nov, 2023 | US11806338 |
| Email Notification
Critical | 07 Nov, 2023 | US11806338 |
| Email Notification
Critical | 19 Oct, 2023 | US11806338 |
| Issue Notification Mailed
Critical | 18 Oct, 2023 | US11806338 |
| Application Is Considered Ready for Issue
Critical | 03 Oct, 2023 | US11806338 |
| Dispatch to FDC | 03 Oct, 2023 | US11806338 |
FDA has granted several exclusivities to Nymalize. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Nymalize, 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
Nymalize.
Exclusivity Information
Nymalize holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Nymalize's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | May 10, 2020 |
| Orphan Drug Exclusivity(ODE-46) | May 10, 2020 |
US patents provide insights into the exclusivity only within the United States, but
Nymalize 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 Nymalize's family patents as well as insights into
ongoing legal events
on those patents.
Nymalize's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nymalize's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 16, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nymalize Generic API suppliers:
Nimodipine is the generic name for the brand Nymalize. 7 different companies have already filed for the generic of Nymalize, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nymalize's generic
How can I launch a generic of Nymalize before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nymalize's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nymalize'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 Nymalize -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 6 mg/mL | 29 Nov, 2021 | 1 | 16 Apr, 2038 |
About Nymalize
Nymalize is a drug owned by Azurity Pharmaceuticals Inc. It is used for improving neurological outcomes and reducing ischemic deficits in adult patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms. Nymalize uses Nimodipine as an active ingredient. Nymalize was launched by Azurity in 2013.
Approval Date:
Nymalize was approved by FDA for market use on 10 May, 2013.
Active Ingredient:
Nymalize uses Nimodipine as the active ingredient. Check out other Drugs and Companies using Nimodipine ingredient
Treatment:
Nymalize is used for improving neurological outcomes and reducing ischemic deficits in adult patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms.
Dosage:
Nymalize is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 6MG/ML | SOLUTION | Prescription | ORAL |