DrugPatentWatch Database Preview
XYWAV Drug Profile
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Which patents cover Xywav, and what generic alternatives are available?
Xywav is a drug marketed by Jazz and is included in one NDA. There are ten 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.
DrugPatentWatch® Generic Entry Outlook for Xywav
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
| International Patents: | 62 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| 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
Generic Entry Date for XYWAV*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT NDA:
Dosage:
SOLUTION;ORAL |
*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 |
US Patents and Regulatory Information for XYWAV
International Patents for XYWAV
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 3335709 | Start Trial |
| Portugal | 2931268 | Start Trial |
| European Patent Office | 3335708 | Start Trial |
| Portugal | 3335708 | Start Trial |
| Croatia | P20200215 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XYWAV
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0720599 | 122014000088 | Germany | Start Trial | PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912 |
| 2957286 | 2018C/047 | Belgium | Start Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721 |
| 2957286 | 300962 | Netherlands | Start Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721 |
| 0720599 | 300689 | Netherlands | Start Trial | PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912 |
| 0247633 | 62/1997 | Austria | Start Trial | 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 |
