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ELUCIREM Drug Patent Profile

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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

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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

Drug patent expirations by year for ELUCIREM

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

Generic Entry Date for ELUCIREM^: ⤷ Sign Up* 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
Johns Hopkins University	Phase 4
Guerbet	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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ELUCIREM is ⤷ Sign Up.

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.

Patents protecting ELUCIREM

Gadolinium bearing PCTA-based contrast agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Compounds comprising short aminoalcohol chains and metal complexes for medical imaging
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting ELUCIREM

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-001	Sep 21, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-005	Sep 21, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-006	Sep 21, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for ELUCIREM

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

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Country	Patent Number	Title	Estimated Expiration
Japan	2013189454	COMPOUND COMPRISING MOIETY FOR RECOGNIZING BIOLOGICAL TARGET COUPLED TO SIGNAL PART CAPABLE OF FORMING COMPLEX WITH GALLIUM	⤷ Sign Up
Japan	7321230		⤷ Sign Up
China	103224495	Compounds comprising short aminoalcohol chains and metal complexes for medical imaging	⤷ Sign Up
South Korea	102438394		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ELUCIREM

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