XYREM Drug Patent Profile

When do Xyrem patents expire, and when can generic versions of Xyrem launch?

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

This drug has thirty-three patent family members in twenty-one countries.

The generic ingredient in XYREM is sodium oxybate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sodium oxybate profile page.

DrugPatentWatch^® Generic Entry Outlook for Xyrem

Xyrem was eligible for patent challenges on July 17, 2006.

There have been fifteen 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.

There are two tentative approvals for the generic drug (sodium oxybate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XYREM

International Patents:	33
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	29
Drug Prices:	Drug price information for XYREM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XYREM
What excipients (inactive ingredients) are in XYREM?	XYREM excipients list
DailyMed Link:	XYREM at DailyMed

See drug prices for XYREM

Pharmacology for XYREM

Drug Class	Central Nervous System Depressant
Physiological Effect	Central Nervous System Depression Decreased Central Nervous System Organized Electrical Activity

Paragraph IV (Patent) Challenges for XYREM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XYREM	Oral Solution	sodium oxybate	500 mg/mL	021196	1	2010-07-08

US Patents and Regulatory Information for XYREM

XYREM is protected by seven US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes	11,986,446
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes	10,864,181*PED				Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes	9,050,302*PED				Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes	8,772,306*PED				Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes	9,486,426*PED				Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes	10,213,400*PED				Y

EU/EMA Drug Approvals for XYREM

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma Ltd	Xyrem	sodium oxybate	EMEA/H/C/000593 Treatment of narcolepsy with cataplexy in adult patients.	Authorised	no	no	no	2005-10-13
D&A Pharma	Hopveus	sodium oxybate	EMEA/H/C/004962 Substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. Treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended.	Refused	no	no	no		2020-07-06

International Patents for XYREM

See the table below for patents covering XYREM 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)
European Patent Office	1140061	SOLUTIONS DE SEL D'HYDROXYBUTYRATE STABLES ET SAINES AU PLAN MICROBIOLOGIQUE, POUR LE TRAITEMENT DE LA NARCOLEPSIE (MICROBIOLOGICALLY SOUND AND STABLE SOLUTIONS OF GAMMA-HYDROXYBUTYRATE SALT FOR THE TREATMENT OF NARCOLEPSY)
Hong Kong	1256965	γ羥基丁酸與單羧酸轉運蛋白的施用 (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS)
European Patent Office	2961399	ADMINISTRATION D'ACIDE 4-HYDROXYBUTANOÏQUE ET DE TRANSPORTEURS MONOCARBOXYLATE (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS)
South Korea	102239042
Spain	2659284
Poland	3335708

Supplementary Protection Certificates for XYREM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	CA 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
2465580	SPC/GB21/030	United Kingdom		PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
0579826	SPC/GB02/042	United Kingdom		PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
2203431	92666	Luxembourg		PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2203431	15C0013	France		PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
2932970	18C1043	France		PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518

XYREM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Xyrem

Introduction to Xyrem

Xyrem, also known as sodium oxybate, is a pivotal drug in the treatment of narcolepsy, particularly for symptoms such as excessive daytime sleepiness (EDS) and cataplexy. It is FDA-approved and has been a dominant player in the global narcolepsy drugs market.

Market Dominance and Share

Xyrem has held a significant market share in the narcolepsy drugs market. As of 2021, it was expected to hold a market share of 52%, making it one of the leading treatments for narcolepsy[1][4].

Key Drivers of Demand

The demand for Xyrem is driven by several key factors:

Improving Diagnostics

Advancements in diagnostic techniques have improved the detection and diagnosis of narcolepsy, leading to increased demand for effective treatments like Xyrem[1][4].

Higher Awareness

Increased awareness about narcolepsy and its symptoms, such as cataplexy and hallucinations, has prompted more patients to seek medical help, thereby driving the demand for Xyrem[1][4].

Dual-Pronged Approach

Xyrem's ability to treat both EDS and cataplexy makes it a preferred treatment option, contributing to its market dominance[1][4].

Regional Market Dynamics

Developed Regions

Europe and North America are the current leaders in the narcolepsy drugs market, including Xyrem. These regions benefit from better medical care infrastructure and higher healthcare spending, which supports the continued growth of Xyrem sales[1][4].

Emerging Markets

The Asia Pacific region, particularly countries like India, China, and Japan, presents lucrative opportunities for Xyrem. Growing stress levels, sleep disorders due to shift-based work, and increasing medical awareness are expected to drive the demand for narcolepsy drugs in these regions[1][4].

Financial Performance

Recent Trends

Despite its market dominance, Xyrem's sales have seen a decline in recent years. For example, in 2023, Xyrem net product sales decreased by 44% to $569.7 million compared to 2022. This decline continued in the fourth quarter of 2023, with sales dropping by 57% to $106.7 million[2][5].

Impact of Competition

The decline in Xyrem sales is partly due to the strong adoption of Xywav, another product by Jazz Pharmaceuticals, among existing Xyrem patients. Additionally, competition from high-sodium oxybate authorized generics has also impacted Xyrem's revenue[2].

Future Outlook

Market Growth

The global narcolepsy drugs market, including Xyrem, is expected to grow at a CAGR of 11.2% between 2021 and 2025. This growth is anticipated despite the current decline in Xyrem sales, as the overall market demand for narcolepsy treatments continues to rise[1][4].

Revenue Guidance

Jazz Pharmaceuticals, the manufacturer of Xyrem, has provided revenue guidance that reflects continued top-line growth, albeit with a decline in Xyrem sales offset by growth in other key products like Xywav and Epidiolex. The company expects total revenue to grow by 7% at the mid-point for 2024[2].

Competitive Landscape

Xyrem faces competition from other treatments and generics. For instance, the introduction of high-sodium oxybate authorized generics has impacted its market share. However, Xyrem remains a critical treatment option due to its FDA approval and effectiveness in managing narcolepsy symptoms[1][2].

Conclusion

Xyrem remains a significant player in the narcolepsy drugs market, driven by its effectiveness in treating EDS and cataplexy. While its sales have declined recently due to competition and the adoption of other products, the overall market for narcolepsy treatments is expected to grow. This growth, coupled with the expanding awareness and diagnostic capabilities, ensures that Xyrem will continue to be an important treatment option for narcolepsy patients.

Key Takeaways

• Market Share: Xyrem held a 52% market share in the narcolepsy drugs market as of 2021.
• Demand Drivers: Improving diagnostics, higher awareness, and its dual-pronged approach in treating EDS and cataplexy drive demand.
• Regional Dynamics: Developed regions like Europe and North America lead, while Asia Pacific offers growing opportunities.
• Financial Performance: Recent sales have declined due to competition from Xywav and authorized generics.
• Future Outlook: The global narcolepsy drugs market is expected to grow at a CAGR of 11.2% between 2021 and 2025.

FAQs

Q: What is Xyrem used for? A: Xyrem, or sodium oxybate, is used to treat excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy.

Q: Why is Xyrem's market share declining? A: Xyrem's sales have declined due to the strong adoption of Xywav among existing Xyrem patients and competition from high-sodium oxybate authorized generics.

Q: Which regions are leading the narcolepsy drugs market? A: Europe and North America are the current leaders, while the Asia Pacific region presents growing opportunities.

Q: What is the expected growth rate of the global narcolepsy drugs market? A: The market is expected to grow at a CAGR of 11.2% between 2021 and 2025.

Q: How has the COVID-19 pandemic affected the demand for narcolepsy drugs? A: The pandemic has highlighted sleep disorders, contributing to an increased demand for narcolepsy treatments like Xyrem.

Sources

1. Worldwide Narcolepsy Drugs Industry to 2025 - Key Drivers, Restraints, and Opportunities - ResearchAndMarkets.com
2. Jazz Pharmaceuticals Announces Full Year and Fourth Quarter 2023 Financial Results and Provides 2024 Financial Guidance
3. Jazz Pharmaceuticals, Inc. - Investors
4. Global Narcolepsy Drugs Market (2021 to 2026) - Growth, Trends, and Forecasts
5. Jazz Pharmaceuticals Announces Third Quarter 2023 Financial Results and Updates Financial Guidance