Lofexidine hydrochloride - Generic Drug Details

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What are the generic sources for lofexidine hydrochloride and what is the scope of freedom to operate?

Lofexidine hydrochloride is the generic ingredient in two branded drugs marketed by Indoco and Uswm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for lofexidine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	42
Patent Applications:	271
What excipients (inactive ingredients) are in lofexidine hydrochloride?	lofexidine hydrochloride excipients list
DailyMed Link:	lofexidine hydrochloride at DailyMed

Recent Clinical Trials for lofexidine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
USWM, LLC (dba US WorldMeds)	Phase 2
BioXcel Therapeutics Inc	Phase 1/Phase 2
National Institute on Drug Abuse (NIDA)	Phase 1/Phase 2

See all lofexidine hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for lofexidine hydrochloride

N07BC	Drugs used in opioid dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for lofexidine hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Uswm	LUCEMYRA	lofexidine hydrochloride	TABLET;ORAL	209229-001	May 16, 2018	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Indoco	LOFEXIDINE HYDROCHLORIDE	lofexidine hydrochloride	TABLET;ORAL	218613-001	Aug 20, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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