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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 ninety patent family members in twenty-six countries.

The generic ingredient in ELUCIREM is gadopiclenol. Two 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:	90
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	3
Patent Applications:	4
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
Guerbet	Phase 4
Johns Hopkins University	Phase 4
Guerbet	Phase 3

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	11,590,246		Y
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-005	Sep 21, 2022		RX	Yes	Yes	11,590,246		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	10,973,934			Y
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-001	Sep 21, 2022		RX	Yes	Yes
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-003	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
China	103224495	Compounds comprising short aminoalcohol chains and metal complexes for medical imaging
Hungary	E060343
Japan	5706926
China	101305006	Compounds comprising short aminoalcohol chains and metal complexes for medical imaging
Portugal	3687994
Portugal	1931673
Portugal	3943493

Supplementary Protection Certificates for ELUCIREM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1931673	301259	Netherlands		PRODUCT NAME: GADOPICLENOL; REGISTRATION NO/DATE: EU/1/23/1772 20231208

ELUCIREM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Elucirem

Introduction

Elucirem, a macrocyclic gadolinium-based contrast agent (GBCA) developed by Guerbet, has marked a significant milestone in the field of medical imaging. Here, we delve into the market dynamics and financial trajectory of this innovative drug.

FDA Approval and Global Market Authorisation

Elucirem received FDA approval in September 2022 after a priority review, making it the first health authority to approve the drug. This approval was a crucial step, as it paved the way for its use in contrast-enhanced magnetic resonance imaging (MRI) in the United States[1].

Following the FDA approval, Elucirem also received marketing authorisation from the European Commission in December 2023, based on the positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP)[4].

Clinical Indications and Benefits

Elucirem is indicated for use in adults and children aged two years and older for contrast-enhanced MRI to detect and visualize lesions with abnormal vascularity in various body regions, including the central nervous system, head and neck, thorax, abdomen, pelvis, and musculoskeletal system. Its high relaxivity allows it to be used at half the conventional dose of gadolinium compared to other non-specific GBCAs, addressing concerns about gadolinium exposure[1][4][5].

Market Performance and Growth

Guerbet's financial performance has been robust, driven in part by the success of Elucirem. In the first half of 2024, Guerbet's sales totalled €419.2 million, up 10.7% compared to the same period in 2023, and 11.8% at constant exchange rates (CER)[2][3].

Geographical Breakdown

• EMEA Region: Despite a temporary decline in the first quarter due to reforms in the French market, the region saw a recovery in the second quarter, resulting in a 2.4% growth at CER[2][3].
• Americas: The region experienced significant growth, with revenue increasing by 29.1% at CER, driven by strong catch-up in the US and market share gains in Latin America, particularly in Brazil[2][3].
• Asia: Growth remained strong in the first half, with an 11.5% increase at CER, although the second quarter saw a slowdown due to a doctor strike in South Korea[2][3].

Product-Specific Performance

The MRI division, particularly driven by Elucirem, saw a solid performance. In the first half of 2024, MRI sales increased by 5.2% at CER, with a notable acceleration in the second quarter (+13.5%). This growth was fueled by the expansion of Elucirem in the US and its initial sales in Germany[2][3].

Financial Projections and Profitability

Guerbet has revised its annual growth targets upward, expecting sales growth of over 9% in 2024 like-for-like and at CER, compared to the previous forecast of over 8%[2][3].

The company also anticipates an improvement in operating profitability, with a restated EBITDA margin rate higher than in 2021 (14.4%). The first half of 2024 saw a strong rise in EBITDA (+32.9%) to €61.0 million, reflecting a margin rate of 14.6% of revenue. Operating income almost tripled to €30.3 million compared to the same period in 2023[2].

Production and Distribution

Elucirem is produced in France and the USA. The industrial investment for Elucirem has been significant, amounting to 22.5 million euros over the past five years. The active pharmaceutical ingredient and its starting material are manufactured in France, while the finished product is filled in vials and prefilled syringes in both France and the USA[4].

Strategic Impact

The approval and market performance of Elucirem reinforce Guerbet's strategic perspective of combining medical innovation with environmental commitment. As noted by David Hale, CEO of Guerbet Group, "This approval allows patients and practitioners to benefit from the innovations brought by Elucirem"[1].

Environmental and Social Commitment

Guerbet's commitment to environmental sustainability is evident in its production and distribution practices. The company aims to minimize its environmental footprint while delivering innovative medical solutions[4].

Key Takeaways

• FDA and EU Approval: Elucirem has received approvals from both the FDA and the European Commission, marking its entry into key global markets.
• Market Growth: Strong sales growth driven by Elucirem, particularly in the Americas and Europe.
• Financial Performance: Improved profitability with a significant increase in EBITDA and operating income.
• Production and Distribution: Strategic manufacturing and distribution across France and the USA.
• Clinical Benefits: High relaxivity and reduced gadolinium dose, addressing practitioner concerns.

FAQs

Q: What is Elucirem, and how is it used?

A: Elucirem is a macrocyclic gadolinium-based contrast agent (GBCA) used in contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in various body regions.

Q: What are the key benefits of Elucirem compared to other GBCAs?

A: Elucirem has the highest relaxivity in its class, allowing it to be used at half the conventional dose of gadolinium, which reduces exposure concerns.

Q: Where is Elucirem produced and distributed?

A: Elucirem is produced in France and the USA, with finished products filled in vials and prefilled syringes in both countries.

Q: How has the market responded to Elucirem?

A: The market response has been positive, with significant sales growth in the Americas and Europe, contributing to Guerbet's overall financial performance.

Q: What are Guerbet's financial projections for 2024?

A: Guerbet expects sales growth of over 9% in 2024 like-for-like and at CER, with an improved EBITDA margin rate higher than in 2021.

Sources

1. Guerbet announces FDA approval of Elucirem - Interventional News
2. GUERBET : H1 2024 results - GlobeNewswire
3. GUERBET : H1 2024 revenue - GlobeNewswire
4. Guerbet announces marketing authorisation approval of Elucirem - PR Newswire
5. Guerbet Releases First Production Batch of Elucirem - PR Newswire