Details for New Drug Application (NDA): 220295
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NDA 220295 describes LYNAVOY, which is a drug marketed by Intercept and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the LYNAVOY profile page.
The generic ingredient in LYNAVOY is linerixibat. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the linerixibat profile page.
The generic ingredient in LYNAVOY is linerixibat. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the linerixibat profile page.
Summary for 220295
| Tradename: | LYNAVOY |
| Applicant: | Intercept |
| Ingredient: | linerixibat |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220295
Generic Entry Date for 220295*:
Constraining patent/regulatory exclusivity:
TREATMENT OF CHOLESTATIC PRURITUS ASSOCIATED WITH PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULT PATIENTS 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.
Pharmacology for NDA: 220295
| Mechanism of Action | Ileal Bile Acid Transporter Inhibitors |
Suppliers and Packaging for NDA: 220295
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LYNAVOY | linerixibat | TABLET;ORAL | 220295 | NDA | Intercept Pharmaceuticals Inc | 69516-140 | 69516-140-60 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69516-140-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Mar 17, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 17, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 17, 2033 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF CHOLESTATIC PRURITUS ASSOCIATED WITH PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULT PATIENTS | ||||||||
| Patent: | 9,040,518 | Patent Expiration: | Sep 6, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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