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 four patents protecting this drug.

This drug has one hundred and eight patent family members in twenty-eight 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 January 17, 2040. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ELUCIREM

International Patents:	108
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	5
Patent Applications:	22
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:

11,590,246

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 four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,590,246.

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	216986-006	Sep 21, 2022		RX	Yes	Yes	11,590,246		Y
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-005	Sep 21, 2022		RX	Yes	Yes	10,973,934			Y

International Patents for ELUCIREM

When does loss-of-exclusivity occur for ELUCIREM?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Denmark

European Patent Office

Finland

France

Hungary

Israel

Japan

Mexico

Morocco

Philippines

Poland

Portugal

Serbia

Singapore

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Australia	2019319599
Brazil	112021001102
Canada	3105610

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
1931673	CA 2024 00011	Denmark		PRODUCT NAME: GADOPICLENOL; REG. NO/DATE: EU/1/23/1772 20231208
1931673	122024000009	Germany		PRODUCT NAME: GADOPICLENOL; REGISTRATION NO/DATE: EU/1/23/1772 20231207

Last updated: July 22, 2026

ELUCIREM market dynamics and financial trajectory: sales drivers, pricing, exclusivity, and generic risk

ELUCIREM is not a trackable, uniquely identifiable FDA-approved branded pharmaceutical product with a consistent global INN/active ingredient mapping based on publicly indexable identifiers available in this environment. No reliable linkage can be made between “ELUCIREM” and a specific active ingredient, NDA/BLA, Orange Book record, launch date, sales base, patent estate, or litigation dataset.

As a result, a complete and accurate market-dynamics and financial-trajectory analysis cannot be produced without inventing assumptions.

What company sells ELUCIREM and where does it generate revenue?

No verified issuer-to-brand mapping is available for “ELUCIREM,” including manufacturer identity, distribution geography, or revenue reporting line items. Without an anchored brand-to-NDA/BLA record, revenue sources, payer coverage, and channel mix cannot be stated.

ELUCIREM pricing dynamics: how do discounts, rebates, and net price evolve after launch?

Net price drivers require access to drug-specific reimbursement data (contracted ASP/AMP history), payer coverage assumptions, and geography-specific pricing. No drug-specific pricing history can be tied to ELUCIREM in a verifiable way.

ELUCIREM sales trajectory: when does it peak and what drives growth or decline?

A sales trajectory requires verified baseline sales, quarterly/annual shipment or revenue reporting, and market adoption metrics (new patient starts, persistence, formulary position). No ELUCIREM dataset can be validated to compute adoption curves, peak timing, or decline triggers.

What patents protect ELUCIREM and when do they expire?

Patent-expiration timelines depend on a precise Orange Book/NDA-to-patent linkage. No verified ELUCIREM patent estate can be produced without identifying the underlying active ingredient and application number.

How many patents cover ELUCIREM and what types (composition, method-of-use, formulation)?

Patent-type mapping cannot be generated without an Orange Book record.

When does ELUCIREM lose exclusivity (NCE, 5-year, 3-year, pediatric, use-code exclusivity)?

Exclusivity calculations require NDA regulatory history and Orange Book exclusivity codes tied to a verified application.

What Orange Book status is ELUCIREM and what generic entry risks exist?

Orange Book status (approved listed drug, patent expiration, carve-outs, 505(b)(2) activity) must be tied to a verified NDA and listing set. Generic entry risk analysis cannot be grounded without that linkage.

Has ELUCIREM faced Paragraph IV challenges or biosimilar competition?

Paragraph IV events and biosimilar risk require validated FDA litigation and Patent Challenge data to a specific application. No verified ELUCIREM application linkage exists.

What patent litigation affects ELUCIREM and how do settlements change launch timing?

Litigation and settlement-driven entry timing require verified case dockets and settlement terms tied to ELUCIREM’s application and patent list. No verifiable mapping is possible in this environment.

How does ELUCIREM compare with competing drugs in the same therapeutic class?

Comparative market dynamics require the therapeutic indication, mechanism, and competitor list based on a verified drug product. Those inputs cannot be validated for ELUCIREM here.

Regulatory milestones for ELUCIREM: NDA/BLA pathway and FDA approval timeline

Regulatory milestone analysis requires an identifiable application number and submission/approval dates. Those cannot be reliably assigned to ELUCIREM.

Manufacturing and supply chain risks for ELUCIREM: what could disrupt sales?

Manufacturing risk assessment needs verified facility details, inspection events, and drug substance/drug product supply continuity tied to the product record. No verified product record exists for ELUCIREM.

Commercial exposure: how much revenue depends on ELUCIREM and what is the forecast sensitivity?

Revenue exposure calculations require: historical revenue, guidance targets, and management commentary tied to a confirmed brand. No verifiable revenue series can be linked to ELUCIREM.

Key Takeaways

• ELUCIREM cannot be mapped to a verifiable active ingredient, FDA application, Orange Book listing, or patent/litigation record in this environment.
• Without that anchor, market dynamics, net pricing behavior, sales trajectory, and exclusivity-driven generic risk cannot be analyzed accurately.
• No defensible financial trajectory or patent-timing assessment can be produced without inventing facts.

FAQs

1. What is ELUCIREM’s FDA approval status (NDA/BLA) and approval date?
2. What is ELUCIREM’s Orange Book listing status and patent expiration schedule?
3. Have any Paragraph IV generic challenges been filed against ELUCIREM?
4. What is the mechanism of action and indication for ELUCIREM?
5. Which competitors drive market share in ELUCIREM’s therapeutic niche?

References

1. Orange Book data (FDA) and FDA drug databases were not verifiably linkable to “ELUCIREM” in this environment.