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Xywav is a drug marketed by Jazz and is included in one NDA. There are eleven patents protecting this drug.
This drug has sixty-two patent family members in twenty-three countries.
The generic ingredient in XYWAV is calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate. There are two hundred and eighty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate profile page.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 21, 2023. This may change due to patent challenges or generic licensing.
There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for XYWAV
|Finished Product Suppliers / Packagers:||1|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price information for XYWAV|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for XYWAV|
|What excipients (inactive ingredients) are in XYWAV?||XYWAV excipients list|
|DailyMed Link:||XYWAV at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for XYWAV
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for XYWAV
|Drug Class||Central Nervous System Depressant |
|Physiological Effect||Central Nervous System Depression |
Decreased Central Nervous System Organized Electrical Activity
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|2957286||C02957286/01||Switzerland||Try Before You Buy||PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017|
|0521471||C300125||Netherlands||Try Before You Buy||PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106|
|0933372||PA2008006||Lithuania||Try Before You Buy||PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712|
|0247633||62/1997||Austria||Try Before You Buy||PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|