LUMRYZ Drug Patent Profile

Which patents cover Lumryz, and when can generic versions of Lumryz launch?

Lumryz is a drug marketed by Avadel Cns and is included in one NDA. There are twenty-nine patents protecting this drug.

This drug has thirty patent family members in ten countries.

The generic ingredient in LUMRYZ 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 Lumryz

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 LUMRYZ

International Patents:	30
US Patents:	29
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Patent Applications:	75
Drug Prices:	Drug price information for LUMRYZ
What excipients (inactive ingredients) are in LUMRYZ?	LUMRYZ excipients list
DailyMed Link:	LUMRYZ at DailyMed

See drug prices for LUMRYZ

Pharmacology for LUMRYZ

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

US Patents and Regulatory Information for LUMRYZ

LUMRYZ is protected by twenty-nine US patents and three 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
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-002	May 1, 2023		RX	Yes	No	11,826,335
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-002	May 1, 2023		RX	Yes	No	11,602,513
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-003	May 1, 2023		RX	Yes	No	11,779,557
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-003	May 1, 2023		RX	Yes	No	11,065,224		Y
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-004	May 1, 2023		RX	Yes	No	10,952,986
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-004	May 1, 2023		RX	Yes	No	12,138,239		Y

EU/EMA Drug Approvals for LUMRYZ

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 LUMRYZ

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

Country	Patent Number	Title	Estimated Expiration
China	113473980	在进食状态下具有改善的药代动力学的γ-羟基丁酸酯组合物 (GAMMA-HYDROXYBUTYRATE COMPOSITIONS HAVING IMPROVED PHARMACOKINETICS IN THE FED STATE)
European Patent Office	3930702	COMPOSITIONS DE GAMMA-HYDROXYBUTYRATE PRÉSENTANT UNE PHARMACOCINÉTIQUE AMÉLIORÉE À L'ÉTAT ALIMENTÉ (GAMMA-HYDROXYBUTYRATE COMPOSITIONS HAVING IMPROVED PHARMACOKINETICS IN THE FED STATE)
European Patent Office	3487483	FORMULATIONS À LIBÉRATION MODIFIÉE DE GAMMA-HYDROXYBUTYRATE AYANT UNE PHARMACOCINÉTIQUE AMÉLIORÉE (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS)
Japan	6683886
Japan	7553453
Japan	2024069488	薬物動態が改善された放出調節ガンマ－ヒドロキシ酪酸塩製剤 (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS)

Supplementary Protection Certificates for LUMRYZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	1890030-8	Sweden		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
2203431	2015/009	Ireland		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
1856135	CR 2020 00018	Denmark		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
2822954	SPC/GB18/031	United Kingdom		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
0290047	SPC/GB97/078	United Kingdom		PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522

Market Dynamics and Financial Trajectory for LUMRYZ

Introduction

LUMRYZ, an extended-release formulation of sodium oxybate developed by Avadel Pharmaceuticals, has been making significant waves in the pharmaceutical market since its launch in June 2023. Here, we delve into the market dynamics and financial trajectory of this groundbreaking drug.

FDA Approval and Clinical Superiority

LUMRYZ received FDA approval for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy, marking a significant milestone. The FDA determined that LUMRYZ, dosed once at bedtime, demonstrates clinical superiority over twice-nightly oxybate products, a finding upheld by a recent court ruling[4][5].

Market Performance

Since its launch, LUMRYZ has shown robust market penetration. Here are some key highlights:

Q2 2024 Performance

• Net revenue from LUMRYZ sales reached $41.5 million, a substantial increase from the $1.5 million in Q2 2023.
• The patient base expanded to over 1,900 as of June 30, 2024, up from 1,400 in March and 900 in December 2023[2].

Q3 2024 Performance

• Avadel generated $50 million in net product revenue from LUMRYZ sales in the third quarter of 2024.
• As of September 30, 2024, there were 2,300 patients on LUMRYZ, with 700 patients initiating therapy during the quarter[4][5].

Patient Demand and Enrollment

• The drug has seen consistent and growing patient demand, particularly among those new to oxybate therapy. Over 3,800 patients are enrolled in support services, and 2,400 have initiated therapy since the launch[2][4].

Financial Highlights

Here are the key financial metrics that highlight the trajectory of LUMRYZ:

Revenue Growth

• In the fourth quarter of 2023, Avadel estimated $19 million in net revenue from LUMRYZ sales, with a full-year estimate of $28 million[1].
• Q2 2024 saw a significant jump to $41.5 million in net revenue, and Q3 2024 further increased to $50 million[2][4].

Gross Profit and Net Loss

• In Q2 2024, the gross profit from LUMRYZ sales was $38.7 million, while the net loss was $13.8 million, an improvement from the $64.4 million loss in Q2 2023[2].
• Despite the net loss, the company's financial performance indicates a positive trend, driven by increasing revenue and improving operational efficiencies.

Cash Position

• As of December 31, 2023, Avadel had approximately $105 million in cash, cash equivalents, and marketable securities. By June 30, 2024, this had decreased to $71.4 million, reflecting ongoing investments in R&D and marketing efforts[1][2].

Pipeline and Future Indications

Avadel is actively expanding the potential indications for LUMRYZ:

Idiopathic Hypersomnia

• The company has initiated a Phase 3 trial (REVITALYZ study) to evaluate the efficacy and safety of LUMRYZ in idiopathic hypersomnia, a condition characterized by excessive daytime sleepiness without cataplexy[2][4].

Pediatric Narcolepsy

• Avadel is awaiting an FDA decision on the supplemental New Drug Application (sNDA) for LUMRYZ in pediatric narcolepsy, with a PDUFA date set for September 7, 2024. This could significantly expand the patient population for LUMRYZ[2][4].

Regulatory and Legal Wins

• The FDA approval for pediatric use and the court ruling affirming LUMRYZ's clinical superiority over twice-nightly oxybate products have been crucial in solidifying its market position. This has also secured Orphan Drug Exclusivity through October 16, 2031[4][5].

Provider and Patient Engagement

• Nearly 1,800 healthcare providers have completed the LUMRYZ REMS (Risk Evaluation and Mitigation Strategy) certification process, including both experienced oxybate prescribers and new providers. This widespread adoption among healthcare professionals is a testament to the drug's acceptance and efficacy[1].

Key Takeaways

• Strong Revenue Growth: LUMRYZ has generated significant revenue, with $41.5 million in Q2 2024 and $50 million in Q3 2024.
• Expanding Patient Base: The patient base has grown substantially, with over 2,300 patients on LUMRYZ as of September 30, 2024.
• Regulatory and Legal Successes: FDA approval for pediatric use and a court ruling affirming clinical superiority have strengthened LUMRYZ's market position.
• Pipeline Progress: Ongoing Phase 3 trials for idiopathic hypersomnia and an impending FDA decision on pediatric narcolepsy indicate potential future growth.

FAQs

Q: What is LUMRYZ, and what is it used for?

A: LUMRYZ is an extended-release formulation of sodium oxybate approved by the FDA for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy.

Q: How has LUMRYZ performed financially since its launch?

A: LUMRYZ has shown strong financial performance, with net revenue of $41.5 million in Q2 2024 and $50 million in Q3 2024, indicating robust market penetration.

Q: What are the future indications being explored for LUMRYZ?

A: Avadel is exploring LUMRYZ for idiopathic hypersomnia through a Phase 3 trial and is awaiting an FDA decision on its use in pediatric narcolepsy.

Q: How many patients are currently using LUMRYZ?

A: As of September 30, 2024, there were 2,300 patients on LUMRYZ, with 700 patients initiating therapy during the third quarter.

Q: What regulatory and legal milestones has LUMRYZ achieved?

A: LUMRYZ has received FDA approval for pediatric use and has been upheld in court as clinically superior to twice-nightly oxybate products, securing Orphan Drug Exclusivity through 2031.

Sources

1. Avadel Pharmaceuticals Announces Strong LUMRYZ Launch Performance and Provides Preliminary Fourth Quarter and Full Year 2023 Financial Highlights. Avadel Pharmaceuticals.
2. Avadel Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2024 Financial Results. Stock Titan.
3. Avadel Pharmaceuticals Announces Data Supporting Clinical Profile for LUMRYZ™ Sodium Oxybate. Nasdaq.
4. Avadel's Narcolepsy Treatment Lumryz Brings in $50 Million in Q3. Sleep Review Magazine.
5. Avadel Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2024 Financial Results. Avadel Pharmaceuticals.