Details for New Drug Application (NDA): 218860
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NDA 218860 describes IQIRVO, which is a drug marketed by Ipsen and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the IQIRVO profile page.
The generic ingredient in IQIRVO is elafibranor. One supplier is listed for this compound. Additional details are available on the elafibranor profile page.
The generic ingredient in IQIRVO is elafibranor. One supplier is listed for this compound. Additional details are available on the elafibranor profile page.
Summary for 218860
| Tradename: | IQIRVO |
| Applicant: | Ipsen |
| Ingredient: | elafibranor |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218860
Generic Entry Date for 218860*:
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.
Suppliers and Packaging for NDA: 218860
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IQIRVO | elafibranor | TABLET;ORAL | 218860 | NDA | Ipsen Biopharmaceuticals, Inc. | 15054-0080 | 15054-0080-1 | 1 BOTTLE in 1 CARTON (15054-0080-1) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Jun 10, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 10, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 10, 2031 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Patent: | 11,185,519 | Patent Expiration: | Mar 30, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN PATIENTS UNABLE TO TOLERATE UDCA | ||||||||
Expired US Patents for NDA 218860
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ipsen | IQIRVO | elafibranor | TABLET;ORAL | 218860-001 | Jun 10, 2024 | 7,943,661 | ⤷ Subscribe |
| Ipsen | IQIRVO | elafibranor | TABLET;ORAL | 218860-001 | Jun 10, 2024 | 7,632,870 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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