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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.
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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