xywav Drug Patent 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 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
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Questions you can ask:
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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 |
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.
Pharmacology for xywav
Drug Class | Central Nervous System Depressant |
Physiological Effect | Central Nervous System Depression Decreased Central Nervous System Organized Electrical Activity |
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
International Patents for xywav
See the table below for patents covering xywav around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 3335708 | ⤷ Sign Up | |
Singapore | 11201504637T | GAMMA-HYDROXYBUTYRATE COMPOSITIONS AND THEIR USE FOR THE TREATMENT OF DISORDERS | ⤷ Sign Up |
Croatia | P20200215 | ⤷ Sign Up | |
India | 342829 | GAMMA HYDROXYBUTYRATE COMPOSITIONS AND THEIR USE FOR THE TREATMENT OF DISORDERS | ⤷ Sign Up |
Japan | 2016510031 | モノカルボン酸塩若しくはエステル輸送体を伴うγ−ヒドロキシ酪酸塩若しくはエステルの投与 | ⤷ Sign Up |
Spain | 2660056 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for xywav
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2957286 | 6/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721 |
0720599 | CR 2014 00050 | Denmark | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910 |
2957286 | 122018000145 | Germany | ⤷ Sign Up | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719 |
0521471 | SPC/GB03/033 | United Kingdom | ⤷ Sign Up | 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 |
0933372 | PA2008006 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
2957286 | SPC/GB19/003 | United Kingdom | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |