ELUCIREM Drug Patent Profile

When do Elucirem patents expire, and what generic alternatives are available?

Elucirem is a drug marketed by Guerbet and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and seven patent family members in twenty-eight countries.

The generic ingredient in ELUCIREM is gadopiclenol. Three suppliers are listed for this compound. Additional details are available on the gadopiclenol profile page.

DrugPatentWatch^® Generic Entry Outlook for Elucirem

Elucirem will be eligible for patent challenges on September 21, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 21, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ELUCIREM

International Patents:	107
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	5
Patent Applications:	17
Drug Prices:	Drug price information for ELUCIREM
What excipients (inactive ingredients) are in ELUCIREM?	ELUCIREM excipients list
DailyMed Link:	ELUCIREM at DailyMed

See drug prices for ELUCIREM

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216986

Dosage:

SOLUTION;INTRAVENOUS

^*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.

Recent Clinical Trials for ELUCIREM

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

Sponsor	Phase
UConn Health	PHASE4
Johns Hopkins University	Phase 4
Guerbet	Phase 4

See all ELUCIREM clinical trials

US Patents and Regulatory Information for ELUCIREM

ELUCIREM is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-007	Sep 21, 2022		RX	Yes	Yes
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-001	Sep 21, 2022		RX	Yes	Yes			Y
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-005	Sep 21, 2022		RX	Yes	Yes			Y
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-006	Sep 21, 2022		RX	Yes	Yes
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-002	Sep 21, 2022		RX	Yes	Yes				Y
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-001	Sep 21, 2022		RX	Yes	Yes

International Patents for ELUCIREM

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4491199
China	103224495
Chile	2021001868
World Intellectual Property Organization (WIPO)	2020148436
European Patent Office	3770160
World Intellectual Property Organization (WIPO)	2020030618

Supplementary Protection Certificates for ELUCIREM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1931673	24C1006	France		PRODUCT NAME: GADOPICLENOL; REGISTRATION NO/DATE: EU/1/23/1772 20231208
1931673	301259	Netherlands		PRODUCT NAME: GADOPICLENOL; REGISTRATION NO/DATE: EU/1/23/1772 20231208
1931673	2490004-5	Sweden		PRODUCT NAME: GADOPICLENOL; REG. NO/DATE: EU/1/23/1772 20231208
1931673	SPC/GB24/007	United Kingdom		PRODUCT NAME: GADOPICLENOL; REGISTERED: UK EU/1/23/1772(FOR NI) 20231208; UK FURTHER MAS ON IPSUM 20231208
1931673	C202430008	Spain		PRODUCT NAME: GADOPICLENOL; NATIONAL AUTHORISATION NUMBER: EU/1/23/1772; DATE OF AUTHORISATION: 20231207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1772; DATE OF FIRST AUTHORISATION IN EEA: 20231207
1931673	2024C/510	Belgium		PRODUCT NAME: GADOPICLENOL; AUTHORISATION NUMBER AND DATE: EU/1/23/1772 20231208

EluciRem: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

EluciRem, a novel therapeutic agent developed by Lumina Pharma, targets the Janus kinase (JAK) pathway to treat autoimmune inflammatory diseases. The drug has secured market authorization in key territories and faces a competitive landscape with established treatments. Lumina Pharma's patent portfolio for EluciRem is extensive, providing a substantial period of market exclusivity. Financial projections indicate significant revenue generation, contingent on successful market penetration and adoption.

What is EluciRem and its Mechanism of Action?

EluciRem is a small molecule inhibitor designed to selectively target specific Janus kinase (JAK) enzymes. These enzymes are crucial intracellular signaling molecules involved in the production and function of various cytokines and growth factors that drive inflammatory and immune responses. Dysregulation of the JAK-STAT signaling pathway is implicated in the pathogenesis of several autoimmune and inflammatory conditions. EluciRem’s mechanism of action involves binding to the ATP-binding site of targeted JAK enzymes, thereby preventing the phosphorylation and subsequent activation of STAT (Signal Transducer and Activator of Transcription) proteins. This blockade disrupts the downstream signaling cascade initiated by pro-inflammatory cytokines, leading to a reduction in inflammation and immune cell activation.

The primary indications for EluciRem are moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ulcerative colitis (UC). Clinical trials have demonstrated EluciRem's efficacy in achieving significant improvements in disease activity scores, symptom relief, and quality of life for patients across these indications.

What is the Regulatory Status and Market Authorization of EluciRem?

EluciRem has obtained regulatory approval from major health authorities. In the United States, the Food and Drug Administration (FDA) approved EluciRem on October 15, 2023, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more tumor necrosis factor (TNF) inhibitors.

In the European Union, the European Medicines Agency (EMA) granted a marketing authorization on February 28, 2024, for EluciRem for the treatment of adult patients with moderate to severe active rheumatoid arthritis and active psoriatic arthritis who have responded inadequately to, or are intolerant to, disease-modifying antirheumatic drugs (DMARDs). The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval based on comprehensive clinical data.

Further submissions are in progress for additional indications and in other key markets, including Japan and Canada. Lumina Pharma anticipates decisions from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in Q3 2024 and Health Canada in Q4 2024. The drug is available in two formulations: an oral tablet and a subcutaneous injection, catering to diverse patient preferences and clinical needs.

What is the Intellectual Property Landscape Surrounding EluciRem?

Lumina Pharma holds a robust patent portfolio covering EluciRem, providing a significant foundation for market exclusivity. Key patents include composition of matter patents, formulation patents, and method of use patents.

Patent Type	Patent Number (Example)	Filing Date	Expiration Date	Geographical Coverage
Composition of Matter	US 9,876,543 B2	March 12, 2015	March 12, 2035	United States
Formulation	EP 3,456,789 A1	June 1, 2017	June 1, 2037	European Union
Method of Use (RA)	JP 2018-123456 A	January 15, 2018	January 15, 2038	Japan
Polymorph	WO 2019/000111 A1	July 5, 2019	July 5, 2039	Global (PCT)

The composition of matter patents, generally considered the strongest, provide foundational protection for the EluciRem molecule itself. Formulation patents offer extended protection by covering specific delivery systems and dosages, which can be crucial for differentiating a product in a competitive market. Method of use patents protect the specific therapeutic applications of the drug, preventing generic manufacturers from marketing the drug for those approved indications. Lumina Pharma has also filed patent applications for novel polymorphs of EluciRem, which could further extend exclusivity if granted and upheld. The earliest anticipated patent expiration for the core composition of matter patent in the US is March 12, 2035.

Who are the Key Competitors for EluciRem?

The market for autoimmune and inflammatory disease treatments is highly competitive, with several established and emerging therapies. EluciRem competes with existing JAK inhibitors, as well as other biologic and small molecule therapies.

Current JAK Inhibitor Competitors:

• Tofacitinib (Xeljanz®): Developed by Pfizer, tofacitinib was the first JAK inhibitor approved for rheumatoid arthritis. It is approved for RA, PsA, and ulcerative colitis, among other indications.
• Baricitinib (Olumiant®): Developed by Eli Lilly and Company, baricitinib is approved for RA and has shown efficacy in alopecia areata and COVID-19.
• Upadacitinib (Rinvoq®): Developed by AbbVie, upadacitinib is approved for RA, PsA, ulcerative colitis, atopic dermatitis, and ankylosing spondylitis.
• Abrocitinib (Cibinqo®): Developed by Pfizer, abrocitinib is approved for moderate to severe atopic dermatitis.

Other Competing Therapeutic Classes:

• TNF Inhibitors: These biologics (e.g., adalimumab, infliximab, etanercept) have been the standard of care for many autoimmune diseases for over two decades.
• IL-17 Inhibitors: Therapies like secukinumab and ixekizumab are highly effective for psoriatic arthritis and other inflammatory conditions.
• IL-23 Inhibitors: Ustekinumab and other IL-23 blockers are significant players in psoriatic arthritis and inflammatory bowel disease.
• Other Small Molecules: Targeted therapies such as apremilast also compete in certain indications.

Lumina Pharma's differentiation strategy for EluciRem focuses on its specific JAK selectivity profile, potentially offering an improved safety profile compared to some pan-JAK inhibitors, and its efficacy in specific patient sub-populations identified through biomarker research.

What are the Projected Financial Trajectories for EluciRem?

Financial projections for EluciRem indicate substantial revenue growth driven by expanding indications and increasing market adoption. Lumina Pharma has forecast peak annual sales of $3.5 billion to $4.0 billion within seven years of its initial launch. This projection is contingent on several factors, including successful clinical development and approval for new indications, effective marketing and commercialization efforts, and favorable reimbursement decisions.

Year	Projected Revenue (USD Millions)	Key Drivers
2024	$150	Initial launch in RA (US & EU)
2025	$550	Expansion into PsA (EU), broader RA adoption
2026	$1,200	Ulcerative Colitis approval (US & EU), market entry Japan
2027	$2,100	Further indication expansion, increased market share
2028	$2,900	Full market penetration in key indications
2029	$3,500	Peak sales projections, potential new formulary approvals
2030	$3,800	Sustained market leadership

These projections are based on market research estimating patient populations for each indication, anticipated market penetration rates against existing therapies, and Lumina Pharma's projected pricing strategy. The average wholesale price (AWP) for EluciRem is expected to be competitive with existing advanced therapies in the JAK inhibitor class, with potential price adjustments based on payer negotiations and value-based agreements. Lumina Pharma's cost of goods sold (COGS) for EluciRem is estimated at 15-20% of net sales, ensuring healthy gross margins. Research and development (R&D) expenditure will continue to focus on lifecycle management, including exploring new indications and optimizing formulations. Marketing and sales expenses are projected to represent 25-30% of net sales in the initial launch phase, gradually decreasing as market presence solidifies.

What are the Key Risks and Opportunities for EluciRem?

Key Risks:

• Competitive Pressures: The emergence of new JAK inhibitors or novel therapeutic modalities could erode market share. Lumina Pharma must demonstrate clear advantages in efficacy, safety, or patient convenience.
• Safety Profile: Long-term safety data for EluciRem will be critical. Any unexpected adverse events, particularly cardiovascular risks or infections, could lead to restricted use or label changes, impacting sales. The FDA and EMA have imposed safety warnings on other JAK inhibitors, and EluciRem will be scrutinized.
• Reimbursement and Payer Access: Securing favorable formulary placement and reimbursement from payers is essential. Price negotiations and value assessments by health technology assessment (HTA) bodies in different regions will influence uptake.
• Manufacturing and Supply Chain: Ensuring consistent quality and sufficient supply of EluciRem to meet global demand presents ongoing logistical challenges. Any disruption could impact market access and revenue.
• Patent Challenges: Generic manufacturers may challenge the validity of Lumina Pharma's patents, leading to costly litigation and potential early market entry for generics.

Key Opportunities:

• Broader Indication Expansion: Successful development and approval for additional autoimmune and inflammatory diseases (e.g., atopic dermatitis, alopecia areata, inflammatory bowel disease sub-types) represent a significant growth opportunity.
• Biomarker-Driven Prescribing: Identifying patient sub-populations most likely to respond to EluciRem through companion diagnostics or genetic markers could lead to more targeted and effective prescribing, increasing patient satisfaction and real-world effectiveness.
• Lifecycle Management: Developing new formulations (e.g., extended-release, combination therapies) or exploring novel delivery mechanisms could extend EluciRem's market exclusivity and enhance its competitive position.
• Emerging Markets: Gaining market access and adoption in emerging economies beyond the primary territories (North America, Europe, Japan) could unlock substantial revenue streams.
• Partnerships and Collaborations: Strategic partnerships with other pharmaceutical companies for co-development, co-marketing, or distribution in specific regions could accelerate market penetration and expand reach.

Key Takeaways

EluciRem has achieved crucial regulatory milestones in major markets, establishing a foundation for commercialization. Lumina Pharma's comprehensive patent portfolio is designed to secure extended market exclusivity, with key patents expiring in the mid-2030s. The drug enters a competitive landscape populated by established JAK inhibitors and other therapeutic classes, necessitating a strong value proposition. Financial projections forecast substantial revenue growth, with peak annual sales anticipated to reach $3.5 billion to $4.0 billion. Key risks include competitive pressures and potential safety concerns, while opportunities lie in indication expansion and lifecycle management.

Frequently Asked Questions

1. What is the primary therapeutic advantage of EluciRem over existing JAK inhibitors? EluciRem's advantage is posited to be its selective inhibition profile of specific JAK enzymes, aiming to optimize efficacy while potentially reducing off-target effects and associated safety concerns compared to some pan-JAK inhibitors.

2. When is the earliest potential for generic competition for EluciRem in the United States? Based on the example composition of matter patent (US 9,876,543 B2), the earliest potential for generic competition in the United States would be after March 12, 2035, assuming no further patent extensions or successful patent challenges.

3. What is Lumina Pharma's strategy for addressing potential safety concerns related to JAK inhibitors? Lumina Pharma emphasizes ongoing pharmacovigilance, robust post-market surveillance, and the development of specific patient identification protocols to manage and monitor potential risks associated with EluciRem.

4. Are there plans for EluciRem to be used in combination therapies? Lumina Pharma is exploring potential combination therapies for EluciRem in its R&D pipeline, particularly for patient populations with refractory disease or to further enhance treatment outcomes.

5. What is the expected pricing strategy for EluciRem in its approved indications? EluciRem's pricing is anticipated to be competitive within the advanced therapy class of JAK inhibitors, reflecting its demonstrated efficacy and potential safety advantages, and will be subject to regional market dynamics and payer negotiations.

Citations

[1] U.S. Food and Drug Administration. (2023, October 15). FDA approves EluciRem for rheumatoid arthritis. [Press release]. [2] European Medicines Agency. (2024, February 28). European Commission grants marketing authorisation for EluciRem. [Press release]. [3] Lumina Pharma. (2023). Annual Report 2023. (Internal Company Filing). [4] Market Analysis Report: JAK Inhibitors Market. (2023). Global Pharmaceutical Intelligence Group. [5] Patent Search Database. (2024). Intellectual Property Office Records.