Levobupivacaine 0,5% — Competitive Intelligence Brief

Levobupivacaine 0,5% (Levobupivacaine 0,5%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Local anesthetic (amide). Area: Anesthesia.

marketed Local anesthetic (amide) Voltage-gated sodium channels Anesthesia Small molecule

Target snapshot

Levobupivacaine 0,5% (Levobupivacaine 0,5%) — ASST Gaetano Pini-CTO. Levobupivacaine blocks sodium channels in nerve cell membranes, preventing the initiation and propagation of action potentials to produce local anesthesia.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Levobupivacaine 0,5% TARGET	Levobupivacaine 0,5%	ASST Gaetano Pini-CTO	marketed	Local anesthetic (amide)	Voltage-gated sodium channels
Articaine Hydrochloride + Epinephrine	Articaine Hydrochloride + Epinephrine	Ankara Yildirim Beyazıt University	marketed	Local anesthetic with vasoconstrictor	Voltage-gated sodium channels; alpha-1 adrenergic receptors (epinephrine component)
Synera(TM)	Synera(TM)	IWK Health Centre	marketed	Topical local anesthetic	Voltage-gated sodium channels
Ropivacaine + Ketamine	Ropivacaine + Ketamine	Aga Khan University	marketed	Local anesthetic + NMDA receptor antagonist combination	Voltage-gated sodium channels (ropivacaine); NMDA receptor (ketamine)
Paroxetine+Lamotrigine	Paroxetine+Lamotrigine	Ministry of Health & Welfare, Korea	marketed	SSRI + anticonvulsant mood stabilizer combination	Serotonin transporter (SERT); voltage-gated sodium channels; glutamate release modulation
Dose of prilocaine	Dose of prilocaine	Hospital General Universitario Gregorio Marañon	marketed	Local anesthetic (amide class)	Voltage-gated sodium channels
Buffered Articaine Hydrochloride + Epinephrine	Buffered Articaine Hydrochloride + Epinephrine	Ohio State University	marketed	Local anesthetic with vasoconstrictor	Voltage-gated sodium channels; alpha-1 adrenergic receptors (epinephrine component)

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 (Local anesthetic (amide) class)

1. Poznan University of Medical Sciences · 4 drugs in this class
2. Nantes University Hospital · 3 drugs in this class
3. Bozyaka Training and Research Hospital · 2 drugs in this class
4. ASST Gaetano Pini-CTO · 2 drugs in this class
5. Centre Hospitalier Universitaire de Nīmes · 1 drug in this class
6. Chiang Mai University · 1 drug in this class
7. Beijing Tiantan Hospital · 1 drug in this class
8. Complejo Hospitalario Universitario de Granada · 1 drug in this class
9. Ciusss de L'Est de l'Île de Montréal · 1 drug in this class
10. China Medical University, China · 1 drug in this class