Details for New Drug Application (NDA): 217603
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NDA 217603 describes XDEMVY, which is a drug marketed by Tarsus and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the XDEMVY profile page.
The generic ingredient in XDEMVY is lotilaner. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lotilaner profile page.
The generic ingredient in XDEMVY is lotilaner. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lotilaner profile page.
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217603
Generic Entry Date for 217603*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION/DROPS;OPHTHALMIC |
*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: 217603
Suppliers and Packaging for NDA: 217603
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XDEMVY | lotilaner | SOLUTION/DROPS;OPHTHALMIC | 217603 | NDA | Tarsus Pharmaceuticals, Inc. | 81942-125 | 81942-125-01 | 1 BOTTLE, DROPPER in 1 CARTON (81942-125-01) / 10 mL in 1 BOTTLE, DROPPER |
| XDEMVY | lotilaner | SOLUTION/DROPS;OPHTHALMIC | 217603 | NDA | Tarsus Pharmaceuticals, Inc. | 81942-125 | 81942-125-99 | 1 BOTTLE, DROPPER in 1 CARTON (81942-125-99) / 1.5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.25% | ||||
| Approval Date: | Jul 24, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 24, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 14, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 14, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE | ||||||||
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