Is there a generic for Lofexidine hydrochloride?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Lofexidine hydrochloride, referencing the brand LUCEMYRA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Lofexidine hydrochloride?

LUCEMYRA (NDA 209229, BIOCORRX PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Lofexidine hydrochloride are approved?

Lofexidine hydrochloride is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Lofexidine hydrochloride

Lofexidine hydrochloride is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LUCEMYRA · NDA 209229

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
LUCEMYRARLD	BIOCORRX PHARMS	NDA 209229	AB	May 16, 2018

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
LOFEXIDINE HYDROCHLORIDE	NOVITIUM PHARMA	ANDA 219917	AB	Oct 22, 2025
LOFEXIDINE HYDROCHLORIDE	MSN	ANDA 218699	AB	Feb 24, 2025
LOFEXIDINE HYDROCHLORIDE	REGCON HOLDINGS	ANDA 218613	AB	Aug 20, 2024

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Lofexidine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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