DANTROLENE SODIUM Drug Patent Profile
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When do Dantrolene Sodium patents expire, and what generic alternatives are available?
Dantrolene Sodium is a drug marketed by Elite Labs Inc, Impax Labs, Eugia Pharma Speclts, and Hikma. and is included in four NDAs.
The generic ingredient in DANTROLENE SODIUM 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 Dantrolene Sodium
A generic version of DANTROLENE SODIUM was approved as dantrolene sodium by IMPAX LABS on March 1st, 2005.
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Summary for DANTROLENE SODIUM
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 133 |
| Clinical Trials: | 2 |
| Patent Applications: | 10 |
| Drug Prices: | Drug price information for DANTROLENE SODIUM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DANTROLENE SODIUM |
| What excipients (inactive ingredients) are in DANTROLENE SODIUM? | DANTROLENE SODIUM excipients list |
| DailyMed Link: | DANTROLENE SODIUM at DailyMed |
Recent Clinical Trials for DANTROLENE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Beth Israel Deaconess Medical Center | Phase 2 |
| National Institutes of Health (NIH) | Phase 1/Phase 2 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 1/Phase 2 |
Pharmacology for DANTROLENE SODIUM
| Drug Class | Skeletal Muscle Relaxant |
| Physiological Effect | Decreased Striated Muscle Contraction Decreased Striated Muscle Tone |
Medical Subject Heading (MeSH) Categories for DANTROLENE SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for DANTROLENE SODIUM
US Patents and Regulatory Information for DANTROLENE SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Elite Labs Inc | DANTROLENE SODIUM | dantrolene sodium | CAPSULE;ORAL | 076686-001 | Oct 24, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eugia Pharma Speclts | DANTROLENE SODIUM | dantrolene sodium | INJECTABLE;INJECTION | 205239-001 | Feb 18, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Impax Labs | DANTROLENE SODIUM | dantrolene sodium | CAPSULE;ORAL | 076856-001 | Mar 1, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | DANTROLENE SODIUM | dantrolene sodium | INJECTABLE;INJECTION | 204762-001 | Jun 19, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Elite Labs Inc | DANTROLENE SODIUM | dantrolene sodium | CAPSULE;ORAL | 076686-002 | Oct 24, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Elite Labs Inc | DANTROLENE SODIUM | dantrolene sodium | CAPSULE;ORAL | 076686-003 | Oct 24, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
