Ryanodex Patent Expiration

Ryanodex is a drug owned by Eagle Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2014 to 2018. Out of these, 1 drug patents are active and 4 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

(8 months from now)

Active
US8685460 Treatment using dantrolene
Feb, 2023

(1 year, 7 months ago)

Expired
US8110225 Treatment using dantrolene
Dec, 2022

(1 year, 9 months ago)

Expired
US8604072 Treatment using dantrolene
Jul, 2022

(2 years ago)

Expired
US9884044 Treatment using dantrolene
Jun, 2022

(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 Ryanodex's patents.

Given below is the list of recent legal activities going on the following patents of Ryanodex.

Activity Date Patent Number
Patent litigations
Expire Patent 11 Mar, 2024 US8110225
Maintenance Fee Reminder Mailed 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 06 Feb, 2018 US9884044
Patent Issue Date Used in PTA Calculation 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

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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

Ryanodex has patent protection in a total of 7 countries. It has a significant patent presence in the US with 70.8% of its patents being US patents. Click below to unlock the full patent family tree for Ryanodex.

Family Patents

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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 Generics:

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