Sodium oxybate - Generic Drug Details
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What are the generic drug sources for sodium oxybate and what is the scope of patent protection?
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 thirty-seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Sodium oxybate has sixty-six 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: | 66 |
US Patents: | 37 |
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: | 1,964 |
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 |
⤷ Try for Free | ⤷ Try for Free | 500MG/ML | SOLUTION;ORAL |
⤷ Try for Free | ⤷ Try for Free | 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 | 214755-004 | May 1, 2023 | RX | Yes | No | 12,109,186 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-004 | May 1, 2023 | RX | Yes | No | 12,138,239 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-002 | May 1, 2023 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-002 | May 1, 2023 | RX | Yes | No | 12,097,175 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-001 | May 1, 2023 | RX | Yes | Yes | 11,000,498 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-004 | May 1, 2023 | RX | Yes | No | 11,602,513 | ⤷ Try for Free | ⤷ Try for Free | ||||
>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 |
---|---|---|---|
Canada | 2902948 | ADMINISTRATION D'ACIDE 4-HYDROXYBUTANOIQUE ET DE TRANSPORTEURS MONOCARBOXYLATE (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS) | ⤷ Try for Free |
Japan | 2020100670 | 薬物動態が改善された放出調節ガンマ−ヒドロキシ酪酸塩製剤 (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS) | ⤷ Try for Free |
Canada | 3127871 | COMPOSITIONS DE GAMMA-HYDROXYBUTYRATE PRESENTANT UNE PHARMACOCINETIQUE AMELIOREE A L'ETAT ALIMENTE (GAMMA-HYDROXYBUTYRATE COMPOSITIONS HAVING IMPROVED PHARMACOKINETICS IN THE FED STATE) | ⤷ Try for Free |
Canada | 2902948 | ⤷ Try for Free | |
European Patent Office | 3487483 | FORMULATIONS À LIBÉRATION MODIFIÉE DE GAMMA-HYDROXYBUTYRATE AYANT UNE PHARMACOCINÉTIQUE AMÉLIORÉE (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS) | ⤷ Try for Free |
Israel | 240874 | מתן של גמא -הידרוקסיבוטיראט עם נשאי מונוקרבוקסילאט (Administration of gamma hydroxybutyrate with monocarboxylate transporters) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sodium oxybate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2465580 | SPC/GB21/030 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221 |
2666774 | CA 2020 00037 | Denmark | ⤷ Try for Free | 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 |
0473687 | SPC/GB98/030 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204 |
2822954 | SPC/GB18/031 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625 |
0268956 | 1999C0030 | Belgium | ⤷ Try for Free | PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508 |
1758590 | LUC00029 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory of Sodium Oxybate
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