Ryanodex is a drug owned by Eagle Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2014 to 2018 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 30, 2025. Details of Ryanodex'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). | |||
| US7758890 | Treatment using dantrolene |
Jun, 2025
(4 months ago) |
Expired
|
| US8685460 | Treatment using dantrolene |
Feb, 2023
(2 years ago) |
Expired
|
| US8110225 | Treatment using dantrolene |
Dec, 2022
(2 years ago) |
Expired
|
| US8604072 | Treatment using dantrolene |
Jul, 2022
(3 years ago) |
Expired
|
| US9884044 | Treatment using dantrolene |
Jun, 2022
(3 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 Ryanodex's patents.
Latest Legal Activities on Ryanodex's Patents
Given below is the list of recent legal activities going on the following patents of Ryanodex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 11 Mar, 2024 | US8110225 |
| Maintenance Fee Reminder Mailed
Critical | 25 Sep, 2023 | US8110225 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 20 Jan, 2022 | US7758890 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 01 Oct, 2021 | US8685460 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 06 Aug, 2021 | US9884044 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 10 Jun, 2021 | US8604072 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 07 Aug, 2019 | US8110225 |
| Recordation of Patent Grant Mailed
Critical | 06 Feb, 2018 | US9884044 |
| Patent Issue Date Used in PTA Calculation
Critical | 06 Feb, 2018 | US9884044 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 22 Jan, 2018 | US7758890 |
FDA has granted several exclusivities to Ryanodex. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Ryanodex, 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
Ryanodex.
Exclusivity Information
Ryanodex holds 2 exclusivities. All of its exclusivities have expired in 2021. Details of Ryanodex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Jul 22, 2021 |
| Orphan Drug Exclusivity(ODE-69) | Jul 22, 2021 |
US patents provide insights into the exclusivity only within the United States, but
Ryanodex 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 Ryanodex's family patents as well as insights into
ongoing legal events
on those patents.
Ryanodex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ryanodex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 30, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ryanodex Generic API suppliers:
Dantrolene Sodium is the generic name for the brand Ryanodex. 5 different companies have already filed for the generic of Ryanodex, with Elite Labs Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ryanodex's generic
About Ryanodex
Ryanodex is a drug owned by Eagle Pharmaceuticals Inc. It is used for treating and preventing malignant hyperthermia in patients at risk. Ryanodex uses Dantrolene Sodium as an active ingredient. Ryanodex was launched by Eagle Pharms in 2014.
Approval Date:
Ryanodex was approved by FDA for market use on 22 July, 2014.
Active Ingredient:
Ryanodex uses Dantrolene Sodium as the active ingredient. Check out other Drugs and Companies using Dantrolene Sodium ingredient
Treatment:
Ryanodex is used for treating and preventing malignant hyperthermia in patients at risk.
Dosage:
Ryanodex is available in for suspension form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG/VIAL | FOR SUSPENSION | Prescription | INTRAVENOUS |