Details for New Drug Application (NDA): 217899
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NDA 217899 describes LIVDELZI, which is a drug marketed by Gilead Sciences Inc 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 LIVDELZI profile page.
The generic ingredient in LIVDELZI is seladelpar lysine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the seladelpar lysine profile page.
The generic ingredient in LIVDELZI is seladelpar lysine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the seladelpar lysine profile page.
Summary for 217899
| Tradename: | LIVDELZI |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | seladelpar lysine |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217899
Generic Entry Date for 217899*:
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:
CAPSULE;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: 217899
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899 | NDA | Gilead Sciences, Inc | 61958-3301 | 61958-3301-1 | 30 CAPSULE in 1 BOTTLE (61958-3301-1) |
| LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899 | NDA | Gilead Sciences, Inc | 61958-3301 | 61958-3301-2 | 30 CAPSULE in 1 BOTTLE (61958-3301-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Aug 14, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 14, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Aug 14, 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: | ⤷ Start Trial | Patent Expiration: | Mar 19, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) | ||||||||
Expired US Patents for NDA 217899
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | ⤷ Start Trial | ⤷ Start Trial |
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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