Elafibranor - Generic Drug Details
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What are the generic drug sources for elafibranor and what is the scope of freedom to operate?
Elafibranor
is the generic ingredient in one branded drug marketed by Ipsen and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Elafibranor has eighty patent family members in twenty-five countries.
One supplier is listed for this compound.
Summary for elafibranor
| International Patents: | 80 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 13 |
| Patent Applications: | 567 |
| What excipients (inactive ingredients) are in elafibranor? | elafibranor excipients list |
| DailyMed Link: | elafibranor at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for elafibranor
Generic Entry Date for elafibranor*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO URSODEOXYCHOLIC ACID (UDCA), OR IN PATIENTS UNABLE TO TOLERATE UDCA Dosage:
TABLET;ORAL |
*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 elafibranor
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ipsen | Phase 3 |
| Ipsen | Phase 2 |
| Ipsen | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for elafibranor
US Patents and Regulatory Information for elafibranor
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ipsen | IQIRVO | elafibranor | TABLET;ORAL | 218860-001 | Jun 10, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Ipsen | IQIRVO | elafibranor | TABLET;ORAL | 218860-001 | Jun 10, 2024 | RX | Yes | Yes | 11,857,523 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Ipsen | IQIRVO | elafibranor | TABLET;ORAL | 218860-001 | Jun 10, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Ipsen | IQIRVO | elafibranor | TABLET;ORAL | 218860-001 | Jun 10, 2024 | RX | Yes | Yes | 11,331,292 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Ipsen | IQIRVO | elafibranor | TABLET;ORAL | 218860-001 | Jun 10, 2024 | RX | Yes | Yes | 7,943,661 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Ipsen | IQIRVO | elafibranor | TABLET;ORAL | 218860-001 | Jun 10, 2024 | RX | Yes | Yes | 7,632,870 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for elafibranor
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ipsen | IQIRVO | elafibranor | TABLET;ORAL | 218860-001 | Jun 10, 2024 | 7,632,870 | ⤷ Subscribe |
| Ipsen | IQIRVO | elafibranor | TABLET;ORAL | 218860-001 | Jun 10, 2024 | 7,943,661 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for elafibranor
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Cyprus | 1108085 | ⤷ Subscribe | |
| Canada | 2490993 | COMPOSITION A BASE DE DERIVES DE 1,3-DIPHENYLPROP-2-EN-ONE SUBSTITUES (COMPOSITION BASED ON SUBSTITUTED 1,3-DIPHENYLPROP-2-EN-1-ONEDERIVATIVES) | ⤷ Subscribe |
| Brazil | PI0312399 | composição destinada ao tratamento ou à profilaxia de uma patologia ligada à inflamação, à neurodegenerescência, à desregularização do metabolismo lipídico e/ou glicídico, à proliferação e/ou à diferenciação celular e/ou ao envelhecimento cutâneo ou do sistema nervoso central | ⤷ Subscribe |
| European Patent Office | 4233910 | MÉTHODES DE TRAITEMENT DE MALADIES CHOLESTATIQUES (METHODS OF TREATMENT OF CHOLESTATIC DISEASES) | ⤷ Subscribe |
| Israel | 261935 | שיטות לטיפול במחלות עימדון מרה (Methods of treatment of cholestatic diseases) | ⤷ Subscribe |
| Philippines | 12018502056 | METHODS OF TREATMENT OF CHOLESTATIC DISEASES | ⤷ Subscribe |
| >Country | >Patent Number | >Title | >Estimated Expiration |
