SODIUM OXYBATE - Generic Drug Details
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What are the generic drug sources for sodium oxybate and what is the scope of freedom to operate?
Sodium oxybate
is the generic ingredient in three branded drugs marketed by Avadel Cns, Hikma, and Jazz Pharms, and is included in three NDAs. There are twenty-six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Sodium oxybate has sixty-three patent family members in twenty-three countries.
There are five drug master file entries for sodium oxybate. Four suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for SODIUM OXYBATE
International Patents: | 63 |
US Patents: | 26 |
Tradenames: | 3 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 37 |
Clinical Trials: | 50 |
Patent Applications: | 138 |
Drug Prices: | Drug price trends 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 |
Generic filers with tentative approvals for SODIUM OXYBATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 500MG/ML | SOLUTION;ORAL |
⤷ Sign Up | ⤷ Sign Up | 500MG/ML | SOLUTION;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for SODIUM OXYBATE
Drug Class | Central Nervous System Depressant |
Physiological Effect | Central Nervous System Depression Decreased Central Nervous System Organized Electrical Activity |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-001 | May 1, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-003 | May 1, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-003 | May 1, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 |
International Patents for SODIUM OXYBATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 2961399 | ⤷ Sign Up | |
Canada | 3210888 | FORMULATIONS A LIBERATION MODIFIEE DE GAMMA-HYDROXYBUTYRATE AYANT UNE PHARMACOCINETIQUE AMELIOREE (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS) | ⤷ Sign Up |
Spain | 2659284 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SODIUM OXYBATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1912999 | 1490062-5 | Sweden | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
2563920 | CR 2019 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710 |
2666774 | CA 2020 00037 | Denmark | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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