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 two branded drugs marketed by Hikma and Jazz Pharms, and is included in two NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Sodium oxybate has thirty-two patent family members in twenty-one countries.
There are five drug master file entries for sodium oxybate. Two suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for sodium oxybate
International Patents: | 32 |
US Patents: | 8 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 55 |
Clinical Trials: | 47 |
Patent Applications: | 6,414 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | Phase 4 |
Brigham and Women's Hospital | Early Phase 1 |
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | Phase 1 |
Generic filers with tentative approvals for SODIUM OXYBATE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 500MG/ML | SOLUTION;ORAL |
See Plans and Pricing | See Plans and Pricing | 500MG/ML | SOLUTION;ORAL |
See Plans and Pricing | See Plans and Pricing | 9G | SUSPENSION;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
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 | 3335708 | See Plans and Pricing | |
Hong Kong | 1256965 | γ羥基丁酸與單羧酸轉運蛋白的施用 (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS) | See Plans and Pricing |
Israel | 240874 | מתן של גמא -הידרוקסיבוטיראט עם נשאי מונוקרבוקסילאט (Administration of gamma hydroxybutyrate with monocarboxylate transporters) | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2014134380 | See Plans and Pricing | |
Spain | 2775779 | See Plans and Pricing | |
Poland | 3335708 | See Plans and Pricing | |
Canada | 2902948 | ADMINISTRATION D'ACIDE 4-HYDROXYBUTANOIQUE ET DE TRANSPORTEURS MONOCARBOXYLATE (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS) | See Plans and Pricing |
>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 | See Plans and Pricing | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
2932970 | SPC/GB18/041 | United Kingdom | See Plans and Pricing | PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518 |
1259550 | 08C0052 | France | See Plans and Pricing | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
2203431 | 1590018-6 | Sweden | See Plans and Pricing | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 |
0290047 | SPC/GB97/078 | United Kingdom | See Plans and Pricing | PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522 |
2203431 | CA 2015 00014 | Denmark | See Plans and Pricing | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115 |
1856135 | 2020/017 | Ireland | See Plans and Pricing | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTRATION NO/DATE: EU/1/19/1405 20200113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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