DrugPatentWatch Database Preview
XYREM Drug Profile
When do Xyrem patents expire, and what generic alternatives are available?
Xyrem is a drug marketed by Jazz Pharms and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.
This drug has thirty-six patent family members in twenty countries.
The generic ingredient in XYREM is sodium oxybate. There are one thousand four hundred and seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium oxybate profile page.
US ANDA Litigation and Generic Entry Outlook for Xyrem
A generic version of XYREM was approved as sodium oxybate by HIKMA on January 28th, 2020.
Summary for XYREM
| International Patents: | 36 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 16 |
| Patent Applications: | 5,873 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for XYREM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XYREM |
| DailyMed Link: | XYREM at DailyMed |
Recent Litigation for XYREM
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 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| RANBAXY INC | 2016-03-10 |
| Amneal Pharmaceuticals LLC | 2016-02-02 |
| Ranbaxy, Inc. | 2015-10-07 |
Pharmacology for XYREM
| Drug Class | Central Nervous System Depressant |
| Physiological Effect | Central Nervous System Depression Decreased Central Nervous System Organized Electrical Activity |
Synonyms for XYREM
| .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-Hydroxybutyrate sodium |
| 4-Hydroxybutyric acid |
| 4-Hydroxybutyric acid monosodium salt |
| 4-Hydroxycarboxylic acid |
| 4-OHB |
| 52352-27-9 |
| 591-81-1 |
| AA3E2AF0-AB7A-4A1E-A391-199C049D7162 |
| AC1L1V58 |
| AKOS022632618 |
| Alcover |
| AN-8743 |
| Anetamin |
| BDBM50023575 |
| BRN 1720582 |
| Butanoic acid, 4-hydroxy- |
| Butanoic acid, hydroxy-, homopolymer |
| Butanoic acid,4-(1-oxobutoxy)- |
| Butyric acid, 4-hydroxy- |
| Butyric acid, 4-hydroxy-, monosodium salt |
| C00989 |
| C01991 |
| C4H8O3 |
| CHEBI:30830 |
| CHEMBL1342 |
| CTK4G5262 |
| DEA No. 2010 |
| DTXSID2074740 |
| EB 27 |
| Gam-OH |
| Gamma Hydroxybutyric Acid |
| Gamma OH |
| gamma-hydroxy butyrate |
| gamma-Hydroxybutanoic acid |
| gamma-Hydroxybutyrate |
| gamma-Hydroxybutyric acid |
| GHB |
| GTPL4711 |
| HSDB 6927 |
| Hydroxybutyric acid monosodium salt |
| Hydroxybutyric acid- |
| Juice |
| Liquid Ecstasy |
| LMFA01050006 |
| LS-46312 |
| NCGC00247714-01 |
| NSC84223 |
| oxy-n-butyric acid |
| Oxybate |
| Oxybate sodium |
| PDSP1_000342 |
| PDSP2_000340 |
| Poly(hydroxybuyric acid) |
| SBI-0206686.P002 |
| SCHEMBL10786 |
| SHB |
| SJZRECIVHVDYJC-UHFFFAOYSA-N |
| Sodium .gamma.-hydroxybutyrate |
| Sodium .gamma.-oxybutyrate |
| Sodium gamma-oxybutyrate |
| Sodium oxybate |
| Sodium Oxybate (4-hydroxybutanoic acid) |
| Somsanit |
| UNII-30IW36W5B2 |
| WY 3478 |
| WY-3478 |
| ZINC1532805 |
Paragraph IV (Patent) Challenges for XYREM
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| XYREM | SOLUTION;ORAL | sodium oxybate | 021196 | 2010-07-08 |
US Patents and Regulatory Information for XYREM
| 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 | 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 | 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 | 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 XYREM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2015011242 | Start Trial |
| Canada | 2902948 | Start Trial |
| Canada | 2355293 | Start Trial |
| European Patent Office | 1140061 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0038672 | Start Trial |
| Japan | 2002533388 | Start Trial |
| Brazil | 112015021012 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XYREM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0480717 | 98C0022 | France | Start Trial | PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825 |
| 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 |
| 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 |
| 1666481 | 17C1031 | France | Start Trial | PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324 |
| 1758590 | LUC00029 | Luxembourg | Start Trial | PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401 |
| 2822954 | 1890030-8 | Sweden | Start Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625 |
| 2822954 | 18C1035 | France | Start Trial | PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
