DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 209229
NDA 209229 describes LUCEMYRA, which is a drug marketed by Us Worldmeds Llc and is included in one NDA. It is available from one supplier. Additional details are available on the LUCEMYRA profile page.
The generic ingredient in LUCEMYRA is lofexidine hydrochloride. One supplier is listed for this compound. Additional details are available on the lofexidine hydrochloride profile page.
The generic ingredient in LUCEMYRA is lofexidine hydrochloride. One supplier is listed for this compound. Additional details are available on the lofexidine hydrochloride profile page.
Summary for 209229
| Tradename: | LUCEMYRA |
| Applicant: | Us Worldmeds Llc |
| Ingredient: | lofexidine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 209229
Generic Entry Date for 209229*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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.
Suppliers and Packaging for NDA: 209229
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUCEMYRA | lofexidine hydrochloride | TABLET;ORAL | 209229 | NDA | US WorldMeds, LLC | 27505-050 | 27505-050-36 | 1 BOTTLE in 1 CARTON (27505-050-36) > 36 TABLET, FILM COATED in 1 BOTTLE |
| LUCEMYRA | lofexidine hydrochloride | TABLET;ORAL | 209229 | NDA | US WorldMeds, LLC | 27505-050 | 27505-050-96 | 1 BOTTLE in 1 CARTON (27505-050-96) > 96 TABLET, FILM COATED in 1 BOTTLE |
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: | NEW CHEMICAL ENTITY | ||||||||
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