GADOPICLENOL - Generic Drug Details
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What are the generic sources for gadopiclenol and what is the scope of freedom to operate?
Gadopiclenol
is the generic ingredient in one branded drug marketed by Guerbet and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Gadopiclenol has ninety patent family members in twenty-six countries.
Two suppliers are listed for this compound.
Summary for GADOPICLENOL
| International Patents: | 90 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 11 |
| Patent Applications: | 3 |
| What excipients (inactive ingredients) are in GADOPICLENOL? | GADOPICLENOL excipients list |
| DailyMed Link: | GADOPICLENOL at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GADOPICLENOL
Generic Entry Date for GADOPICLENOL*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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 GADOPICLENOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Guerbet | Phase 4 |
| Johns Hopkins University | Phase 4 |
| Guerbet | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for GADOPICLENOL
US Patents and Regulatory Information for GADOPICLENOL
| 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 | 216986-003 | Sep 21, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Guerbet | ELUCIREM | gadopiclenol | SOLUTION;INTRAVENOUS | 216986-007 | Sep 21, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Guerbet | ELUCIREM | gadopiclenol | SOLUTION;INTRAVENOUS | 216986-007 | 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 | 216986-005 | Sep 21, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 GADOPICLENOL
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 1931673 | ⤷ Sign Up | |
| Japan | 5706926 | ⤷ Sign Up | |
| European Patent Office | 3770160 | AGENTS DE CONTRASTE À BASE DE PCTA CONTENANT DU GADOLINIUM (GADOLINIUM BEARING PCTA-BASED CONTRAST AGENTS) | ⤷ Sign Up |
| European Patent Office | 3902800 | COMPLEXE DE GADOLINIUM ET D'UN LIGAND CHELATEUR DERIVE DE PCTA DIASTEREOISOMERIQUEMENT ENRICHI ET PROCEDE DE PREPARATION ET DE PURIFICATION (COMPLEX OF GADOLINIUM AND A CHELATING LIGAND DERIVED FROM A DIASTEREOISOMERICALLY ENRICHED PCTA AND PREPARATION AND PURIFICATION PROCESS) | ⤷ Sign Up |
| Singapore | 11202107779S | DIASTEREOISOMERICALLY ENRICHED COMPLEX OF GADOLINIUM AND OF A PCTA-BASED CHELATING LIGAND, AND PROCESS FOR PREPARING AND PURIFYING SAME | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GADOPICLENOL
| 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 |
