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
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.
Latest 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 |
|---|---|---|
 | ||
| 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 |
Dantrolene Sodium's Family Patents
Explore Our Curated Drug Screens
Dantrolene Sodium Generic API Manufacturers
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, along with the locations of their manufacturing plants worldwide.
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 |
Manufacturing Plant Locations New
Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||||
| Portugal |
| |||||||||
| Jordan |
| |||||||||
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 |