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 five 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. Ten 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: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 72 |
| Clinical Trials: | 3 |
| Patent Applications: | 2,602 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for RYANODEX
US Patents and Regulatory Information for RYANODEX
RYANODEX is protected by five US patents.
Patents protecting RYANODEX
Treatment using dantrolene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Treatment using dantrolene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Treatment using dantrolene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Treatment using dantrolene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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.
Treatment using dantrolene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for RYANODEX
See the table below for patents covering RYANODEX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 4880449 | See Plans and Pricing | |
| European Patent Office | 1603513 | COMPOSITIONS DE DANTROLÈNE (DANTROLENE COMPOSITIONS) | See Plans and Pricing |
| World Intellectual Property Organization (WIPO) | 2005013919 | See Plans and Pricing | |
| Japan | 2007525439 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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