Dantrolene Sodium Patent Expiration

Dantrolene Sodium is Used for treating and preventing malignant hyperthermia in patients at risk. It was first introduced by Endo Operations Ltd in its drug Dantrium on Approved Prior to Jan 1, 1982. Another drug containing Dantrolene Sodium is Ryanodex. 7 different companies have introduced drugs containing Dantrolene Sodium.


Dantrolene Sodium Patents

Given below is the list of patents protecting Dantrolene Sodium, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Ryanodex US7758890 Treatment using dantrolene Jun 30, 2025 Eagle Pharms
Ryanodex US8685460 Treatment using dantrolene Feb 15, 2023

(Expired)

Eagle Pharms
Ryanodex US8110225 Treatment using dantrolene Dec 24, 2022

(Expired)

Eagle Pharms
Ryanodex US8604072 Treatment using dantrolene Jul 20, 2022

(Expired)

Eagle Pharms
Ryanodex US9884044 Treatment using dantrolene Jun 13, 2022

(Expired)

Eagle Pharms



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 Dantrolene Sodium's patents.

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

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


Dantrolene Sodium's Family Patents

Family Patents

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Dantrolene Sodium Generics

Several generic applications have been filed for Dantrolene Sodium. The first generic version for Dantrolene Sodium was by Impax Laboratories Inc and was approved on Mar 1, 2005. And the latest generic version is by Hikma Pharmaceuticals Llc and was approved on Jun 19, 2017.

Given below is the list of companies who have filed for Dantrolene Sodium generic.


1. ELITE LABS INC

Elite Laboratories Inc has filed for 3 different strengths of generic version for Dantrolene Sodium. Given below are the details of the strengths of this generic introduced by Elite Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG capsule Prescription ORAL AB Oct 24, 2005
100MG capsule Prescription ORAL AB Oct 24, 2005
50MG capsule Prescription ORAL AB Oct 24, 2005


2. EUGIA PHARMA SPECLTS

Eugia Pharma Specialities Ltd has filed for 1 generic for Dantrolene Sodium. Given below are the details of the strengths of this generic introduced by Eugia Pharma Speclts.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/VIAL injectable Discontinued INJECTION N/A Feb 18, 2016


3. HIKMA

Hikma Pharmaceuticals Llc has filed for 1 generic for Dantrolene Sodium. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/VIAL injectable Prescription INJECTION AP Jun 19, 2017


4. IMPAX LABS

Impax Laboratories Inc has filed for 3 different strengths of generic version for Dantrolene Sodium. Given below are the details of the strengths of this generic introduced by Impax Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG capsule Prescription ORAL AB Mar 1, 2005
50MG capsule Prescription ORAL AB Mar 1, 2005
100MG capsule Prescription ORAL AB Mar 1, 2005


5. USWM

Uswm Llc has filed for 1 generic for Dantrolene Sodium. This 20mg/vial version comes by the name REVONTO. Given below are the details of the strengths of this generic introduced by Uswm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/VIAL injectable Prescription INJECTION AP Jul 24, 2007