Details for New Drug Application (NDA): 217899
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The generic ingredient in LIVDELZI is seladelpar lysine. One supplier is listed for this compound. Additional details are available on the seladelpar lysine profile page.
Summary for 217899
Tradename: | LIVDELZI |
Applicant: | Cymabay |
Ingredient: | seladelpar lysine |
Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217899
Generic Entry Date for 217899*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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) |
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 | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 19, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 19, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) |
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