DrugPatentWatch Database Preview
XYREM Drug Profile
When do Xyrem patents expire, and when can generic versions of Xyrem launch?
Xyrem is a drug marketed by Jazz Pharms and is included in one NDA. There are eighteen patents protecting this drug and one Paragraph IV challenge.
This drug has thirty patent family members in seventeen countries.
The generic ingredient in XYREM is sodium oxybate. There are one thousand four hundred and fifty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium oxybate profile page.
Summary for XYREM
| International Patents: | 30 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 16 |
| Patent Applications: | 4,269 |
| 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 |
Pharmacology for XYREM
| 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 XYREM
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-Hydroxybutyric acid sodium 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, 4-hydroxy-, sodium salt |
| Butanoic acid,4-(1-oxobutoxy)- |
| Butyric acid, 4-hydroxy- |
| Butyric acid, 4-hydroxy-, monosodium salt |
| BUTYRIC ACID, 4-HYDROXY-, SODIUM SALT |
| C00989 |
| C01991 |
| C4H8O3 |
| CHEBI:30830 |
| CHEMBL1342 |
| CTK4G5262 |
| D0EP8X |
| DEA No. 2010 |
| DTXSID2074740 |
| EB 27 |
| Gam-OH |
| Gamma Hydroxybutyric Acid |
| Gamma OH |
| gamma-hydroxy butyrate |
| gamma-Hydroxy sodium butyrate |
| gamma-Hydroxybutanoic acid |
| gamma-Hydroxybutyrate |
| gamma-Hydroxybutyrate sodium |
| gamma-Hydroxybutyric acid |
| gamma-Hydroxybutyric acid decomposition product |
| Gamma-Hydroxybutyric acid monosodium salt |
| Gamma-OH |
| GHB |
| GTPL4711 |
| HSDB 6927 |
| Hydroxyb |
| Hydroxybutyric acid monosodium salt |
| Hydroxybutyric acid- |
| HYDROXYBUTYRICACID |
| Juice |
| Liquid Ecstasy |
| LMFA01050006 |
| LP090865 |
| LS-46312 |
| NCGC00247714-01 |
| NSC84223 |
| oxy-n-butyric acid |
| Oxybate |
| Oxybate sodium |
| PDSP1_000342 |
| PDSP2_000340 |
| SBI-0206686.P002 |
| SCHEMBL10786 |
| SHB |
| SJZRECIVHVDYJC-UHFFFAOYSA-N |
| Sodium .gamma.-hydroxybutyrate |
| Sodium .gamma.-oxybutyrate |
| Sodium gamma-oxybutyrate |
| Sodium Oxybate (4-hydroxybutanoic acid) |
| Somsanit |
| UNII-30IW36W5B2 |
| utyric acid monosodium salt |
| WY 3478 |
| WY-3478 |
| Xyrem (TN) |
| ZINC1532805 |
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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | AA | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Jazz Pharms | XYREM | sodium oxybate | SOLUTION;ORAL | 021196-001 | Jul 17, 2002 | AA | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for XYREM
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Oral Solution | 500 mg/mL | ➤ Subscribe | ➤ Sign Up |
International Patents for XYREM
Supplementary Protection Certificates for XYREM
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2015 00014 | Denmark | ➤ Sign Up | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115 |
| 666 | Luxembourg | ➤ Sign Up | PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119 |
| C/GB98/040 | United Kingdom | ➤ Sign Up | PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
