SODIUM OXYBATE Drug Patent Profile
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When do Sodium Oxybate patents expire, and when can generic versions of Sodium Oxybate launch?
Sodium Oxybate is a drug marketed by Hikma and is included in one NDA.
The generic ingredient in SODIUM OXYBATE is sodium oxybate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sodium oxybate profile page.
Summary for SODIUM OXYBATE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 37 |
| Clinical Trials: | 50 |
| Patent Applications: | 84 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SODIUM OXYBATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SODIUM OXYBATE |
| What excipients (inactive ingredients) are in SODIUM OXYBATE? | SODIUM OXYBATE excipients list |
| DailyMed Link: | SODIUM OXYBATE at DailyMed |
Recent Clinical Trials for SODIUM OXYBATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mayo Clinic | Phase 4 |
| Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | Phase 4 |
| Brigham and Women's Hospital | Early Phase 1 |
Medical Subject Heading (MeSH) Categories for SODIUM OXYBATE
Anatomical Therapeutic Chemical (ATC) Classes for SODIUM OXYBATE
Paragraph IV (Patent) Challenges for SODIUM OXYBATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| XYREM | Oral Solution | sodium oxybate | 500 mg/mL | 021196 | 1 | 2010-07-08 |
US Patents and Regulatory Information for SODIUM OXYBATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | SODIUM OXYBATE | sodium oxybate | SOLUTION;ORAL | 202090-001 | Jan 17, 2017 | DISCN | No | No | ⤷ 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 |
EU/EMA Drug Approvals for SODIUM OXYBATE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| UCB Pharma Ltd | Xyrem | sodium oxybate | EMEA/H/C/000593 Treatment of narcolepsy with cataplexy in adult patients. |
Authorised | no | no | no | 2005-10-13 | |
| D&A Pharma | Hopveus | sodium oxybate | EMEA/H/C/004962 Substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. Treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended. |
Refused | no | no | no | 2020-07-06 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
