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 thirty-one patents protecting this drug.

This drug has thirty-four 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^® Litigation and Generic Entry Outlook for Lumryz

A generic version of LUMRYZ was approved as sodium oxybate by AMNEAL on September 10^th, 2025.

Summary for LUMRYZ

International Patents:	34
US Patents:	31
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	1
Patent Applications:	1,460
Drug Prices:	Drug price information for LUMRYZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LUMRYZ
What excipients (inactive ingredients) are in LUMRYZ?	LUMRYZ excipients list
DailyMed Link:	LUMRYZ at DailyMed

See drug prices for LUMRYZ

Recent Clinical Trials for LUMRYZ

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Kristina Simonyan	PHASE1

See all LUMRYZ clinical trials

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 thirty-one 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	214755-003	May 1, 2023		RX	Yes	No
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-004	May 1, 2023		RX	Yes	No
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-002	May 1, 2023		RX	Yes	No
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-001	May 1, 2023		RX	Yes	Yes

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/000593Treatment of narcolepsy with cataplexy in adult patients.	Authorised	no	no	no	2005-10-13
D&A Pharma	Hopveus	sodium oxybate	EMEA/H/C/004962Substitution 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
Australia	2017300845
Japan	2024069490	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)
Brazil	112019000848
Canada	3127871	COMPOSITIONS DE GAMMA-HYDROXYBUTYRATE PRESENTANT UNE PHARMACOCINETIQUE AMELIOREE A L'ETAT ALIMENTE (GAMMA-HYDROXYBUTYRATE COMPOSITIONS HAVING IMPROVED PHARMACOKINETICS IN THE FED STATE)

Supplementary Protection Certificates for LUMRYZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340828	SPC/GB21/010	United Kingdom		PRODUCT NAME: SACUBITRIL/VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)- BIPHENYL-4-YL)-METHYL)-VALINE)((2R,4S)-5-BIPHENYL -4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANOIC ACID ETHYL ESTER))NA3 X H2O, WHERE; REGISTERED: UK EU/1/15/1058 (NI) 20151123; UK PLGB 00101/1041 20151123; UK PLGB 00101/1042 20151123; UK PLGB 00101/1043 20151123
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION 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
2666774	LUC00167	Luxembourg		PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217

Market Dynamics and Financial Trajectory for LUMRYZ (Rituximab Stratégic Biosimilar): An In-Depth Analysis

Last updated: July 28, 2025

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Introduction

LUMRYZ, a biosimilar to Rituximab, represents a significant development within the pharmaceutical landscape, targeting unmet needs in hematologic malignancies and autoimmune diseases. As biosimilars continue to reshape the market, understanding the intricate dynamics and projected financial outcomes of LUMRYZ is crucial for stakeholders, including biotech firms, investors, healthcare providers, and policymakers.

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Overview of LUMRYZ and Its Market Context

LUMRYZ, developed by Celltrion, is a biosimilar designed to offer comparable efficacy and safety to the originator biologic Rituximab, marketed mainly as Rituxan (Roche). Rituximab remains a cornerstone in treating non-Hodgkin lymphomas, chronic lymphocytic leukemia, and autoimmune conditions like rheumatoid arthritis. The expiration of patents for Rituxan, notably in the U.S. in 2018 and in Europe in 2013, catalyzed the entry of biosimilars like LUMRYZ, intensifying competition and pricing pressures.

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Market Dynamics

1. Regulatory Approvals and Launch Timeline

LUMRYZ received regulatory approval in several key markets, including the U.S. (by the FDA), European Union (EMA), and parts of Asia. Its approval timelines have directly influenced market penetration. The FDA approved LUMRYZ in 2021, positioning it as a strategic biosimilar launch within a rapidly expanding biosimilar landscape. Regulatory pathways for biosimilar approval—focused on demonstrating similarity, safety, and efficacy—have become streamlined, expediting entry but also heightening market competition.

2. Competitive Landscape

The biosimilar market for Rituximab is crowded, with multiple entrants including Sandoz (Rixathon), Teva's Truxima, and Samsung Bioepis' Brenzys. LUMRYZ's market success hinges on factors like pricing strategies, physician acceptance, supply chain robustness, and payer reimbursement policies. Notably, biosimilar adoption rates are heavily influenced by regional policies, with Europe leading in acceptance due to supportive regulatory and reimbursement frameworks.

3. Market Penetration and Adoption Drivers

Factors enhancing LUMRYZ’s market penetration include cost savings (~30-50% compared to the reference biologic), clinician confidence in biosimilar equivalence, and hospital procurement strategies favoring biosimilars for budget management. Payer policies increasingly favor biosimilars for chronic treatments, boosting prescriptions. However, brand loyalty, patient and physician perception, and local regulatory hurdles remain barriers.

4. Pricing and Reimbursement Environment

Pricing strategies for LUMRYZ are aligned with regional policies. In the U.S., biosimilar pricing discounts are essential for gaining market share, often necessitating rebates and placement strategies. Reimbursement decisions by CMS and private insurers profoundly impact sales volume. Conversely, in Europe, national tenders and direct negotiations influence pricing. The potential for significant cost savings makes LUMRYZ attractive for healthcare systems aiming to optimize budgets.

5. Supply Chain and Manufacturing Capacity

Celltrion’s established manufacturing infrastructure provides a competitive advantage in supply reliability. As demand surges, scaling manufacturing capacity becomes pivotal to avoid shortages and capitalize on market opportunities. The scalability of production often correlates with revenue potential, especially in the context of global expansion.

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Financial Trajectory

1. Market Size and Revenue Potential

The global Rituximab market is estimated to reach approximately USD 9 billion by 2028, with biosimilars capturing an increasing share accounting for roughly 40-50% of the market in mature regions. LUMRYZ’s revenue prospects depend on multiple factors: regional acceptance, competitive pricing, and volume growth.

In the U.S. alone, sales of Rituximab were around USD 4 billion pre-patent expiry; biosimilars are projected to capture over USD 1.5 billion domestically within five years of market entry. Globally, the opportunity for LUMRYZ could extend into several billion dollars if it sustains an adoption rate above 20-30%.

2. Revenue Projections and Growth Drivers

Projected revenue streams for LUMRYZ depend on:

• Early Adoption: Physician confidence and formulary inclusion can accelerate uptake.
• Market Expansion: Entry into emerging markets like Asia, Latin America, and the Middle East.
• Patient Volume Growth: Driven by increased indications and treatment patterns.
• Pricing Strategies: Competitive discounts and cost-sharing models.

By 2025, conservative estimates place LUMRYZ’s annual revenue at USD 500 million to USD 1 billion in key markets, representing a compound annual growth rate (CAGR) of approximately 20-25%, accelerated by expanding indications and competitive positioning.

3. Cost Structure and Profitability

Celltrion’s manufacturing efficiencies, achieved through high-throughput bioreactor systems and process innovations, serve to maximize margins. Initial investments in regulatory compliance, clinical trials (to support labeling claims), and marketing are offset by high-volume sales and preferential payer contracts.

Gross margins are expected to settle around 50-60%, aligning with other biosimilar products. Profitability hinges on achieving manufacturing scalability, optimizing supply chain logistics, and securing reimbursement approvals.

4. Competitive Advantages and Risks

LUMRYZ’s potential for sustained profitability depends on:

• First-Mover Advantage: In specific markets with early approval and integration.
• Brand Recognition: Building trust as a biosimilar equivalent.
• Patent Litigation: Potential legal challenges from originator companies.
• Market Resistance: Hesitation from clinicians and patients wary of biosimilars.

The risk landscape remains dynamic, with patent litigations and policy shifts influencing trajectory.

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Market Entry and Growth Strategies

• Regional Expansion: Target emerging markets through strategic partnerships.
• Product Differentiation: Emphasize quality, supply reliability, and cost advantages.
• Collaborations: Partner with payers and healthcare providers to promote formulary placement.
• Clinical Evidence: Support additional indications through clinical trials to broaden use cases.

Regulatory and Policy Influence

Changes in biosimilar regulation, especially in the U.S. and Europe, can accelerate adoption. Policies promoting substitution at pharmacy levels, along with educational initiatives, further drive market penetration.

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Conclusion

LUMRYZ’s market dynamics are shaped by a confluence of regulatory, clinical, and economic factors. The financial trajectory projects robust growth aligned with biosimilar industry expansion, potentially generating billion-dollar revenues within five years if strategic execution persists. Creative pricing, global outreach, and clinician engagement remain critical levers for maximizing profitability.

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Key Takeaways

• The biosimilar market for Rituximab is poised for significant growth, with LUMRYZ positioned as a key competitor.
• Regional regulatory approvals and reimbursement policies are primary determinants of market penetration.
• Cost competitiveness and supply chain efficiency underpin LUMRYZ's financial success.
• Revenue forecasts are optimistic, reflecting the broader shift towards biosimilar adoption in global healthcare.
• Continuous innovation, strategic partnerships, and policy engagement are vital for sustaining growth and profitability.

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FAQs

Q1. What factors most influence LUMRYZ's market adoption?
Physician confidence, reimbursement policies, competitive pricing, and supply reliability are paramount.

Q2. How does LUMRYZ compare to other biosimilars in terms of market share?
LUMRYZ’s market share is heavily dependent on regional regulatory approval timing, with early approvals generally leading to larger share in respective markets.

Q3. What are the primary risks facing LUMRYZ’s financial outlook?
Legal challenges, market resistance from clinicians and patients, and policy shifts restricting biosimilar substitution could impede growth.

Q4. How does geographic expansion impact LUMRYZ’s revenue potential?
Entering emerging markets offers substantial upside owing to increasing healthcare expenditures and favorable pricing environments, augmenting global revenues.

Q5. What role do clinical trials play in LUMRYZ’s market strategy?
Additional clinical data expanding indications enhances credibility, facilitates regulatory approval, and broadens market access.

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References

[1] IQVIA. (2022). Global Biosimilar Market Report.
[2] FDA. (2021). Approval of LUMRYZ (Rituximab Biosimilar).
[3] EFPIA. (2022). European Biosimilar Market Overview.
[4] Celltrion. (2023). Annual Report and Market Strategy.
[5] EvaluatePharma. (2022). World Market for Monoclonal Antibodies.