DrugPatentWatch Database Preview
Sodium oxybate - Generic Drug Details
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 West-ward Pharms Int and Jazz Pharms, and is included in two NDAs. There are nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Sodium oxybate has thirty-six patent family members in twenty 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: | 36 |
| US Patents: | 19 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 1472 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 39 |
| Clinical Trials: | 42 |
| Patent Applications: | 7,544 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sodium oxybate |
| DailyMed Link: | sodium oxybate at DailyMed |
Recent Clinical Trials for sodium oxybate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Stanford University | Phase 4 |
| Brigham and Women's Hospital | Early Phase 1 |
| University Hospital, Montpellier | Phase 2/Phase 3 |
Recent Litigation for sodium oxybate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| JAZZ PHARMACEUTICALS, INC. v. MALLINCKRODT PLC | 2018-01-02 |
| CELGENE CORPORATION v. LOTUS PHARMACEUTICAL CO., LTD. | 2017-09-06 |
| JAZZ PHARMACEUTICALS, INC. v. ROXANE LABORATORIES, INC. | 2015-02-20 |
See all sodium oxybate litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| RANBAXY INC | 2016-03-10 |
| Amneal Pharmaceuticals LLC | 2016-02-02 |
| Ranbaxy, Inc. | 2015-10-07 |
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
Synonyms for sodium oxybate
| .Gamma.-Hydroxy butyrate |
| .gamma.-Hydroxy sodium butyrate |
| .gamma.-Hydroxybutyrate sodium |
| .gamma.-Hydroxybutyric acid decomposition product |
| .gamma.-Hydroxybutyric acid monosodium salt |
| .gamma.-Hydroxybutyric acid, sodium salt |
| .gamma.-OH |
| 3-carboxypropoxy acid |
| 30470-15-6 |
| 30IW36W5B2 |
| 4 HB |
| 4-03-00-00774 (Beilstein Handbook Reference) |
| 4-hydroxy-butanoic acid |
| 4-hydroxy-butyric acid |
| 4-Hydroxyacid |
| 4-Hydroxyalkanoic acid |
| 4-Hydroxybutanoic acid |
| 4-Hydroxybutanoic acid # |
| 4-Hydroxybuttersaeure |
| 4-Hydroxybuttersaeure natriumsalz |
| 4-Hydroxybutyrate sodium |
| 4-Hydroxybutyric acid |
| 4-Hydroxybutyric acid monosodium salt |
| 4-Hydroxybutyric acid sodium salt |
| 4-Hydroxycarboxylic acid |
| 4-OHB |
| 502-85-2 |
| 52352-27-9 |
| 591-81-1 |
| 7G33012534 |
| AA3E2AF0-AB7A-4A1E-A391-199C049D7162 |
| AC1L1V58 |
| AKOS006221428 |
| AKOS022632618 |
| Alcover |
| AN-8743 |
| Anetamin |
| ARONIS24196 |
| BDBM50023575 |
| BRN 1720582 |
| Butanoic acid, 4-hydroxy- |
| Butanoic acid, 4-hydroxy-, monosodium salt |
| Butanoic acid, 4-hydroxy-, sodium salt |
| Butanoic acid, 4-hydroxy-, sodium salt (1:1) |
| Butanoic acid, hydroxy-, homopolymer |
| Butanoic acid,4-(1-oxobutoxy)- |
| Butyric acid, 4-hydroxy- |
| Butyric acid, 4-hydroxy-, monosodium salt |
| Butyric acid, 4-hydroxy-, monosodium salt (8CI) |
| BUTYRIC ACID, 4-HYDROXY-, SODIUM SALT |
| C-33820 |
| C00989 |
| C01991 |
| C4H8O3 |
| CAS-502-85-2 |
| CC-34496 |
| CCG-212465 |
| CHEBI:30830 |
| CHEMBL1200682 |
| CHEMBL1342 |
| CS-4796 |
| CTK4G5262 |
| D05866 |
| DB-071156 |
| DB09072 |
| DEA No. 2010 |
| DEA No. 2012 |
| DSSTox_CID_28866 |
| DSSTox_GSID_48940 |
| DSSTox_RID_83135 |
| DTXSID2074740 |
| DTXSID3048940 |
| EB 27 |
| EINECS 207-953-3 |
| FT-0626615 |
| Gam-OH |
| Gamma Hydroxybutyric Acid |
| Gamma Hydroxybutyric Acid preparations |
| Gamma OH |
| gamma-hydroxy butyrate |
| gamma-Hydroxy sodium butyrate |
| gamma-Hydroxybutanoic acid |
| gamma-Hydroxybutyrate |
| gamma-Hydroxybutyrate sodium |
| gamma-Hydroxybutyrate sodium salt |
| gamma-Hydroxybutyric acid |
| gamma-Hydroxybutyric acid, sodium salt |
| GHB |
| GHB Sodium Salt (Sodium Gammahydroxybutyrate) |
| GHB|||Sodium oxybate |
| GTPL4711 |
| H-4040 |
| HMS2091E15 |
| HSDB 6927 |
| HY-B1187 |
| Hydroxybutyric acid monosodium salt |
| Hydroxybutyric acid- |
| I14-30979 |
| Juice |
| JZP-6 |
| Liquid Ecstasy |
| LMFA01050006 |
| LS-46312 |
| LS-48077 |
| Natrium 4-hydroxybutyrat |
| NCGC00247714-01 |
| NSC 84223 |
| NSC84223 |
| oxy-n-butyric acid |
| Oxybate |
| Oxybate (sodium) |
| Oxybate sodium |
| PDSP1_000342 |
| PDSP2_000340 |
| Poly(hydroxybuyric acid) |
| SBI-0206686.P002 |
| SCHEMBL10786 |
| SCHEMBL61823 |
| SHB |
| SJZRECIVHVDYJC-UHFFFAOYSA-N |
| Sodium .gamma.-hydroxybutyrate |
| Sodium .gamma.-oxybutyrate |
| sodium 4-hydroxybutanoate |
| Sodium 4-hydroxybutyrate |
| sodium gamma hydroxybutyric acid |
| Sodium gamma-hydroxybutyrate |
| Sodium gamma-oxybutyrate |
| Sodium gammahydroxybutyrate |
| Sodium Oxybate (4-hydroxybutanoic acid) |
| Sodium Oxybate (Sodium 4-Hydroxybutanoate) |
| Sodium oxybate (USAN) |
| Sodium Oxybate [USAN] |
| Sodium Oxybutyrate |
| Sodium-4-hydroxybutyrate |
| sodium;4-hydroxybutanoate |
| SODIUM4-HYDROXYBUTYRATE |
| Somsanit |
| Tox21_112871 |
| UNII-30IW36W5B2 |
| UNII-7G33012534 |
| WY 3478 |
| WY-3478 |
| XYGBKMMCQDZQOZ-UHFFFAOYSA-M |
| Xyrem |
| Xyrem (TN) |
| ZINC1532805 |
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 | AA | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | AA | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | AA | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | AA | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | AA | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | AA | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | AA | 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 |
|---|---|---|
| Denmark | 1140061 | Start Trial |
| Spain | 2659284 | Start Trial |
| Israel | 143733 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0038672 | Start Trial |
| China | 105073106 | Start Trial |
| Portugal | 2961399 | Start Trial |
| European Patent Office | 3335708 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for sodium oxybate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1175904 | 2007C/048 | Belgium | Start Trial | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
| 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 |
| 1912999 | 1490062-5 | Sweden | Start Trial | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
| 2563920 | CA 2019 00001 | Denmark | Start Trial | PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710 |
| 0473687 | SPC/GB98/030 | United Kingdom | Start Trial | PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204 |
| 1259550 | 08C0052 | France | Start Trial | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
| 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 |
| >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 verifification 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.
Copyright 2002-2019 thinkBiotech LLC
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.