You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

~ Buy the XYWAV (calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate) Drug Profile, 2024 PDF Report in the Report Store ~

xywav Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-eight patent family members in twenty-five 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 August 12, 2028. This may change due to patent challenges or generic licensing.

There have been twelve 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

< Available with Subscription >

  Sign Up

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for xywav?
  • What are the global sales for xywav?
  • What is Average Wholesale Price for xywav?
Summary for xywav
International Patents:78
US Patents:14
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
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
Drug patent expirations by year for xywav
Drug Prices for xywav

See drug prices for xywav

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for xywav
Generic Entry Date for xywav*:
Constraining patent/regulatory exclusivity:
THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS
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.

Paragraph IV (Patent) Challenges for XYWAV
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XYWAV Oral Solution calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate 0.234 g/0.096 g/ 013 g/0.04 g per mL 212690 1 2021-04-12

US Patents and Regulatory Information for xywav

xywav is protected by fifteen US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of xywav is ⤷  Sign Up.

This potential generic entry date is based on THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting xywav

Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method of using gamma-hydroxybutyrate compositions for the treatment of disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY WITH A MIXTURE OF SODIUM, POTASSIUM, MAGNESIUM, AND CALCIUM SALTS OF GHB

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY WITH A MIXTURE OF SODIUM, POTASSIUM, MAGNESIUM, AND CALCIUM SALTS OF GHB ADMINISTERED BETWEEN 2 AND 4 HOURS AFTER EATING


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED

Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting xywav

INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY
Exclusivity Expiration: ⤷  Sign Up

INDICATED FOR THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS
Exclusivity Expiration: ⤷  Sign Up

THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 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

International Patents for xywav

See the table below for patents covering xywav around the world.

Country Patent Number Title Estimated Expiration
Brazil 112015014007 ⤷  Sign Up
Singapore 11201505029Q ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS ⤷  Sign Up
India 342829 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for xywav

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 300689 Netherlands ⤷  Sign Up 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
2957286 LUC00094 Luxembourg ⤷  Sign Up PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286 122018000145 Germany ⤷  Sign Up PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.