DANTRIUM Drug Patent Profile
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Which patents cover Dantrium, and what generic alternatives are available?
Dantrium is a drug marketed by Par Sterile Products 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.
Summary for DANTRIUM
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 105 |
Clinical Trials: | 2 |
Patent Applications: | 1,594 |
Formulation / Manufacturing: | see details |
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 |
University of Massachusetts, Worcester | Phase 1/Phase 2 |
American Heart Association | Phase 1/Phase 2 |
Pharmacology for DANTRIUM
Drug Class | Skeletal Muscle Relaxant |
Physiological Effect | Decreased Striated Muscle Contraction Decreased Striated Muscle Tone |
Anatomical Therapeutic Chemical (ATC) Classes for DANTRIUM
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Par Sterile Products | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Par Sterile Products | DANTRIUM | dantrolene sodium | INJECTABLE;INJECTION | 018264-001 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Par Sterile Products | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Par Sterile Products | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 DANTRIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Par Sterile Products | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Par Sterile Products | DANTRIUM | dantrolene sodium | INJECTABLE;INJECTION | 018264-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Par Sterile Products | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Par Sterile Products | DANTRIUM | dantrolene sodium | CAPSULE;ORAL | 017443-003 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Austria | 263759 | ⤷ Try a Trial | |
Netherlands | 147434 | ⤷ Try a Trial | |
Norway | 118068 | ⤷ Try a Trial | |
Sweden | 303758 | ⤷ Try a Trial | |
Denmark | 116509 | ⤷ Try a Trial | |
Germany | 1620093 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |