RYANODEX Drug Patent Profile
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Which patents cover Ryanodex, and when can generic versions of Ryanodex launch?
Ryanodex is a drug marketed by Eagle Pharms and is included in one NDA. There are two patents protecting this drug.
This drug has eight patent family members in five countries.
The generic ingredient in RYANODEX is dantrolene sodium. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ryanodex
A generic version of RYANODEX was approved as dantrolene sodium by IMPAX LABS on March 1st, 2005.
Summary for RYANODEX
International Patents: | 8 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 125 |
Clinical Trials: | 3 |
Patent Applications: | 2,760 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for RYANODEX |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RYANODEX |
What excipients (inactive ingredients) are in RYANODEX? | RYANODEX excipients list |
DailyMed Link: | RYANODEX at DailyMed |


Recent Clinical Trials for RYANODEX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Eagle Pharmaceuticals, Inc. | Phase 3 |
Quintiles, Inc. | Phase 2 |
Eagle Pharmaceuticals, Inc. | Phase 2 |
Pharmacology for RYANODEX
Drug Class | Skeletal Muscle Relaxant |
Physiological Effect | Decreased Striated Muscle Contraction Decreased Striated Muscle Tone |
Anatomical Therapeutic Chemical (ATC) Classes for RYANODEX
US Patents and Regulatory Information for RYANODEX
RYANODEX is protected by two US patents.
Patents protecting RYANODEX
Treatment using dantrolene
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Treatment using dantrolene
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR USE IN THE TREATMENT OF MALIGNANT HYPERTHERMIA IN CONJUNCTION WITH APPROPRIATE SUPPORTIVE MEASURES AND FOR THE PREVENTION OF MALIGNANT HYPERTHERMIA IN PATIENTS AT HIGH RISK.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for RYANODEX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RYANODEX
See the table below for patents covering RYANODEX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1603513 | COMPOSITIONS DE DANTROLÈNE (DANTROLENE COMPOSITIONS) | ⤷ Try a Trial |
Japan | 4880449 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 03000057 | ⤷ Try a Trial | |
Australia | 2004262507 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2005013919 | ⤷ Try a Trial | |
European Patent Office | 1435781 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |