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Last Updated: October 6, 2022

xywav Drug Patent Profile


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Which patents cover Xywav, and when can generic versions of Xywav launch?

Xywav is a drug marketed by Jazz and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-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 eleven 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

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Drug patent expirations by year for xywav
Drug Prices for xywav

See drug prices for xywav

DrugPatentWatch® Estimated Generic Entry Opportunity 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 twelve US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of xywav is See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of using gamma-hydroxybutyrate compositions for the treatment of disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sensitive drug distribution system and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS
Exclusivity Expiration: See Plans and Pricing

THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
European Patent Office 3335708 ADMINISTRATION D'ACIDE 4-HYDROXYBUTANOÏQUE ET DE TRANSPORTEURS MONOCARBOXYLATE (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS) See Plans and Pricing
Singapore 11201504637T GAMMA-HYDROXYBUTYRATE COMPOSITIONS AND THEIR USE FOR THE TREATMENT OF DISORDERS See Plans and Pricing
Spain 2827005 See Plans and Pricing
Spain 2660056 See Plans and Pricing
Hong Kong 1215181 γ-羥基丁酸鹽組合物及其治療疾病的用途 (GAMMA HYDROXYBUTYRATE COMPOSITIONS AND THEIR USE FOR THE TREATMENT OF DISORDERS) See Plans and Pricing
Croatia P20201685 See Plans and Pricing
Taiwan 201831174 Gamma-hydroxybutyrate compositions and their use for the treatment of disorders See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for xywav

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2957286 122018000145 Germany See Plans and Pricing PRODUCT NAME: PATIROMER SORBITEX CALCIUM IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286 LUC00094 Luxembourg See Plans and Pricing PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286 2018C/047 Belgium See Plans and Pricing PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286 2018/046 Ireland See Plans and Pricing PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
0933372 13/2008 Austria See Plans and Pricing PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
2957286 1990003-4 Sweden See Plans and Pricing PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721
2365988 LUC00061 Luxembourg See Plans and Pricing PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Merck
Baxter
Boehringer Ingelheim
Express Scripts
Harvard Business School

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.