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Last Updated: March 28, 2024

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XYWAV Drug Patent Profile


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When do Xywav patents expire, and what generic alternatives are available?

Xywav is a drug marketed by Jazz and is included in one NDA. There are thirteen 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

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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 thirteen US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XYWAV is ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method of using gamma-hydroxybutyrate compositions for the treatment of disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

INDICATED FOR THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS
Exclusivity Expiration: ⤷  Try a Trial

THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 XYWAV

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

Country Patent Number Title Estimated Expiration
Mexico 2015007531 COMPOSICIONES DE GAMMA-HIDROXIBUTIRATO Y SUS USOS PARA EL TRATAMIENTO DE TRASTORNOS. (GAMMA-HYDROXYBUTYRATE COMPOSITIONS AND THEIR USE FOR THE TREATMENT OF DISORDERS.) ⤷  Try a Trial
Taiwan I812557 ⤷  Try a Trial
Japan 6215347 ⤷  Try a Trial
Slovenia 3335708 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XYWAV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2957286 SPC/GB19/003 United Kingdom ⤷  Try a Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTERED: UK EU/1/17/1179/001(NI) 20170721; UK EU/1/17/1179/002(NI) 20170721; UK EU/1/17/1179/003(NI) 20170721; UK EU/1/17/1179/004(NI) 20170721; UK EU/1/17/1179/005(NI) 20170721; UK EU/1/17/1179/006(NI) 20170721; UK EU/1/17/1179/007(NI) 20170721; UK EU/1/17/1179/008(NI) 20170721; UK EU/1/17/1179/009(NI) 20170721; UK PLGB 50784/0002-0001 20170721; UK PLGB 50784/0003-0001 20170721; UK PLGB 50784/0004-0001 20170721
2957286 2018/046 Ireland ⤷  Try a Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286 132019000000021 Italy ⤷  Try a Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721
0521471 SPC/GB03/033 United Kingdom ⤷  Try a Trial PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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