lofexidine HCl — Competitive Intelligence Brief

lofexidine HCl (lofexidine HCl) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Alpha-2 adrenergic agonist. Area: Addiction Medicine / Substance Use Disorder.

marketed Alpha-2 adrenergic agonist Alpha-2 adrenergic receptor Addiction Medicine / Substance Use Disorder Small molecule

Target snapshot

lofexidine HCl (lofexidine HCl) — USWM, LLC (dba US WorldMeds). Lofexidine is an alpha-2 adrenergic agonist that reduces noradrenergic hyperactivity in the central nervous system to alleviate opioid withdrawal symptoms.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
lofexidine HCl TARGET	lofexidine HCl	USWM, LLC (dba US WorldMeds)	marketed	Alpha-2 adrenergic agonist	Alpha-2 adrenergic receptor
transdermal clonidine	transdermal clonidine	Peking University People's Hospital	marketed	Alpha-2 adrenergic agonist	Alpha-2 adrenergic receptor
brimonidine 0.1% (Alphagan® P)	brimonidine 0.1% (Alphagan® P)	Allergan	marketed	Alpha-2 adrenergic receptor agonist	Alpha-2 adrenergic receptor
Dexmedetomidine and propofol	Dexmedetomidine and propofol	Ain Shams University	marketed	Sedative-hypnotic combination	Alpha-2 adrenergic receptor (dexmedetomidine); GABA-A receptor (propofol)
Dexmedetomidine 1	Dexmedetomidine 1	National Cancer Institute, Egypt	marketed	Alpha-2 adrenergic receptor agonist	Alpha-2 adrenergic receptor
Dexmedetomidine load	Dexmedetomidine load	University of Pennsylvania	marketed	Alpha-2 adrenergic agonist	Alpha-2 adrenergic receptor
Sufentanil and dexmedetomidine	Sufentanil and dexmedetomidine	Obstetrics & Gynecology Hospital of Fudan University	marketed	Opioid agonist and alpha-2 adrenergic agonist combination	Mu opioid receptor and alpha-2 adrenergic receptor

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Alpha-2 adrenergic agonist class)

1. USWM, LLC (dba US WorldMeds) · 2 drugs in this class
2. China International Neuroscience Institution · 1 drug in this class
3. Icahn School of Medicine at Mount Sinai · 1 drug in this class
4. Eye Therapies, LLC · 1 drug in this class
5. Galderma R&D · 1 drug in this class
6. Guangzhou Women and Children's Medical Center · 1 drug in this class
7. Derm Research, PLLC · 1 drug in this class
8. Irmandade da Santa Casa de Misericordia de Sao Paulo · 1 drug in this class
9. KK Women's and Children's Hospital · 1 drug in this class
10. American University of Beirut Medical Center · 1 drug in this class