DrugPatentWatch Database Preview
Sodium oxybate - Generic Drug Details
» See Plans and Pricing
What are the generic 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 fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Sodium oxybate has forty-six patent family members in twenty-three countries.
There are one thousand four hundred and seventy-two drug master file entries for sodium oxybate. One supplier is listed for this compound. There are two tentative approvals for this compound.
Summary for sodium oxybate
International Patents: | 46 |
US Patents: | 14 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 1472 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 25 |
Clinical Trials: | 45 |
Patent Applications: | 7 |
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 |
---|---|
Avadel | Phase 3 |
Fundacio Lluita Contra la SIDA | Phase 1 |
Stanford University | Phase 4 |
Generic filers with tentative approvals for SODIUM OXYBATE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 500MG/ML | SOLUTION;ORAL |
Start Trial | Start Trial | 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
Paragraph IV (Patent) Challenges for SODIUM OXYBATE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
XYREM | SOLUTION;ORAL | sodium oxybate | 021196 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for sodium oxybate
Country | Patent Number | Estimated Expiration |
---|---|---|
Austria | 238783 | Start Trial |
Singapore | 11201505029Q | Start Trial |
Poland | 2961399 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for sodium oxybate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2822954 | LUC00083 | Luxembourg | Start Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625 |
1499331 | SPC/GB13/034 | United Kingdom | Start Trial | PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313 |
1948158 | 1690020-1 | Sweden | Start Trial | PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:






Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.