XYWAV Drug Patent Profile

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 sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-two patent family members in twenty-six 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 twenty-three 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

Summary for XYWAV

International Patents:	92
US Patents:	16
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XYWAV

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 seventeen US patents and three FDA Regulatory Exclusivities.

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.

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

International Patents for XYWAV

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

Country	Patent Number	Title	Estimated Expiration
Australia	2013359114	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Brazil	112015014007	composições de gama-hidroxibutirato e sua utilização para o tratamento de distúrbios
Canada	2894876	COMPOSITIONS DE GAMMA-HYDROXYBUTYRATE ET LEUR UTILISATION POUR LE TRAITEMENT DE TROUBLES (GAMMA-HYDROXYBUTYRATE COMPOSITIONS AND THEIR USE FOR THE TREATMENT OF DISORDERS)
China	105025892	γ‑羟基丁酸盐组合物及其治疗疾病的用途 (Gamma-hydroxybutyrate compositions and their use for the treatment of disorders)
Cyprus	1119918
Cyprus	1123498

Supplementary Protection Certificates for XYWAV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3752510	2025C/547	Belgium		PRODUCT NAME: VANZACAFTOR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, BIJ VOORKEUR EEN CALCIUMZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/25/1943 20250701
2957286	SPC/GB19/003	United Kingdom		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	C02957286/01	Switzerland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017
2957286	122018000145	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	LUC00094	Luxembourg		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2365988	CA 2018 00006	Denmark		PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721