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Details for New Drug Application (NDA): 209229
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The generic ingredient in LUCEMYRA is lofexidine hydrochloride. Additional details are available on the lofexidine hydrochloride profile page.
Summary for 209229
Tradename: | LUCEMYRA |
Applicant: | Uswm |
Ingredient: | lofexidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 209229
Generic Entry Date for 209229*:
Constraining patent/regulatory exclusivity:
FDA exclusivity 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.
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.18MG BASE | ||||
Approval Date: | May 16, 2018 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | May 16, 2023 | ||||||||
Regulatory Exclusivity Use: |
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