DANTRIUM Drug Patent Profile
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Which patents cover Dantrium, and what generic alternatives are available?
Dantrium is a drug marketed by Endo Operations and is included in two NDAs.
The generic ingredient in DANTRIUM 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 Dantrium
A generic version of DANTRIUM was approved as dantrolene sodium by IMPAX LABS on March 1st, 2005.
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Summary for DANTRIUM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,594 |
| Drug Prices: | Drug price information for DANTRIUM |
| What excipients (inactive ingredients) are in DANTRIUM? | DANTRIUM excipients list |
| DailyMed Link: | DANTRIUM at DailyMed |
Recent Clinical Trials for DANTRIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Beth Israel Deaconess Medical Center | Phase 2 |
| American Heart Association | Phase 1/Phase 2 |
| University of Massachusetts, Worcester | Phase 1/Phase 2 |
Pharmacology for DANTRIUM
| Drug Class | Skeletal Muscle Relaxant |
| Physiological Effect | Decreased Striated Muscle Contraction Decreased Striated Muscle Tone |
US Patents and Regulatory Information for DANTRIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Endo Operations | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Endo Operations | DANTRIUM | dantrolene sodium | INJECTABLE;INJECTION | 018264-001 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Endo Operations | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Endo Operations | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| >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 DANTRIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Endo Operations | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-001 | Approved Prior to Jan 1, 1982 | 3,415,821 | ⤷ Subscribe |
| Endo Operations | DANTRIUM | dantrolene sodium | INJECTABLE;INJECTION | 018264-001 | Approved Prior to Jan 1, 1982 | 3,415,821 | ⤷ Subscribe |
| Endo Operations | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-002 | Approved Prior to Jan 1, 1982 | 3,415,821 | ⤷ Subscribe |
| Endo Operations | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-003 | Approved Prior to Jan 1, 1982 | 3,415,821 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DANTRIUM
See the table below for patents covering DANTRIUM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Sweden | 303758 | ⤷ Subscribe | |
| Norway | 118068 | ⤷ Subscribe | |
| Switzerland | 483446 | Verfahren zur Herstellung von 1-((5-substituierten)-Furfurylidenamino)-hydantoinen und -imidazolidinonen | ⤷ Subscribe |
| Netherlands | 6612588 | ⤷ Subscribe | |
| >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.
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