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Last Updated: May 21, 2022

Details for New Drug Application (NDA): 209229

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NDA 209229 describes LUCEMYRA, which is a drug marketed by Uswm and is included in one NDA. Additional details are available on the LUCEMYRA profile page.

The generic ingredient in LUCEMYRA is lofexidine hydrochloride. Additional details are available on the lofexidine hydrochloride profile page.
Summary for 209229
Ingredient:lofexidine hydrochloride
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 209229
Generic Entry Date for 209229*:
Constraining patent/regulatory exclusivity:

*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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.18MG BASE
Approval Date:May 16, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:May 16, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Serving leading biopharmaceutical companies globally:

Express Scripts
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