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XYREM Drug Profile
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» See Plans and PricingWhen 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 fourteen patents protecting this drug and one Paragraph IV challenge.
This drug has forty-one patent family members in twenty-three 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 17th, 2017.
Summary for XYREM
| International Patents: | 41 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 16 |
| Patent Applications: | 7,191 |
| 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 |
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 | 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 | |||
| >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 |
|---|---|---|
| Poland | 2961399 | Start Trial |
| Denmark | 2961399 | Start Trial |
| Japan | 2002533388 | Start Trial |
| European Patent Office | 1316309 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XYREM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203431 | CR 2015 00014 | Denmark | Start Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 |
| 0268956 | 1999C0030 | Belgium | Start Trial | PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508 |
| 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 |
| 2673237 | 1990016-6 | Sweden | Start Trial | PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; REG. NO/DATE: EU/1/17/1173 20180326 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
