Details for New Drug Application (NDA): 220018
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NDA 220018 describes YEZTUGO, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the YEZTUGO profile page.
The generic ingredient in YEZTUGO is lenacapavir sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lenacapavir sodium profile page.
The generic ingredient in YEZTUGO is lenacapavir sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lenacapavir sodium profile page.
Summary for 220018
| Tradename: | YEZTUGO |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | lenacapavir sodium |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220018
Generic Entry Date for 220018*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
SOLUTION;SUBCUTANEOUS |
*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: 220018
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| YEZTUGO | lenacapavir sodium | SOLUTION;SUBCUTANEOUS | 220018 | NDA | Gilead Sciences, Inc. | 61958-3402 | 61958-3402-1 | 1 KIT in 1 CARTON (61958-3402-1) * 1.5 mL in 1 VIAL (61958-3403-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) | ||||
| Approval Date: | Jun 18, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 22, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 18, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 17, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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