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 thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-seven 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 fourteen 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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Summary for XYWAV

International Patents:	77
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product 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

Drug patent expirations by year for XYWAV

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XYWAV

Generic Entry Date for XYWAV^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS NDA: 212690 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

Anatomical Therapeutic Chemical (ATC) Classes for XYWAV

N01AX	Other general anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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 four 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