Tolperisone Hydrochloride — Competitive Intelligence Brief

Tolperisone Hydrochloride (Tolperisone Hydrochloride) competitive landscape: 2 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Centrally acting muscle relaxant. Area: Neurology.

phase 3 Centrally acting muscle relaxant Neurology Small molecule

Target snapshot

Tolperisone Hydrochloride (Tolperisone Hydrochloride) — Neurana Pharmaceuticals, Inc.. Tolperisone hydrochloride is a centrally acting muscle relaxant that reduces muscle tone and spasticity by modulating neural pathways in the spinal cord.

Comparator set (2 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Tolperisone Hydrochloride TARGET	Tolperisone Hydrochloride	Neurana Pharmaceuticals, Inc.	phase 3	Centrally acting muscle relaxant
Norgesic	acetylsalicylic acid	Endo	marketed	centrally acting muscle relaxant with anticholinergic properties	reticular formation (brain stem)	1950-01-01
Flexeril Oral Product	Flexeril Oral Product	University of California, Davis	marketed	Centrally acting muscle relaxant

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)

• 2032-09-29 — Norgesic · 10646431 · US
• 2032-09-29 — Norgesic · 10786444 · US
• 2032-09-29 — Norgesic · 9226892 · US
• 2032-09-29 — Norgesic · 9216150 · US
• 2033-01-02 — Norgesic · 9987231 · US
• 2033-03-13 — Norgesic · 9539214 · US

Sponsor landscape (Centrally acting muscle relaxant class)

1. Neurana Pharmaceuticals, Inc. · 1 drug in this class
2. University of California, Davis · 1 drug in this class