Bupivacaine 0.5% — Competitive Intelligence Brief

Bupivacaine 0.5% (Bupivacaine 0.5%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Local anesthetic (amide class). Area: Anesthesia.

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

Target snapshot

Bupivacaine 0.5% (Bupivacaine 0.5%) — Kasr El Aini Hospital. Bupivacaine is a local anesthetic that blocks sodium channels in nerve cell membranes, preventing the initiation and propagation of nerve impulses.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Bupivacaine 0.5% TARGET	Bupivacaine 0.5%	Kasr El Aini Hospital	marketed	Local anesthetic (amide class)	Voltage-gated sodium channels
Lidocaïne	Lidocaïne	University Hospital, Angers	marketed	Local anesthetic	Voltage-gated sodium channels
Hydrocortisone acetate and lidocaine hydrochloride	Hydrocortisone acetate and lidocaine hydrochloride	Citius Pharmaceuticals, Inc.	marketed	Topical corticosteroid and local anesthetic combination	Glucocorticoid receptor (hydrocortisone); voltage-gated sodium channels (lidocaine)
Lidocaine alone	Lidocaine alone	TriHealth Inc.	marketed	Local anesthetic	Voltage-gated sodium channels
lidocaine and sufentanil	lidocaine and sufentanil	RenJi Hospital	marketed	Local anesthetic and opioid analgesic combination	Voltage-gated sodium channels (lidocaine); mu opioid receptor (sufentanil)
Low-Dose Lidocaine	Low-Dose Lidocaine	The Methodist Hospital Research Institute	marketed	Local anesthetic / sodium channel blocker	Voltage-gated sodium channels
Naropeine (Ropivacaine)	Naropeine (Ropivacaine)	Nantes University Hospital	marketed	Local anesthetic (amide)	Voltage-gated sodium channels

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) class)

1. Ain Shams University · 2 drugs in this class
2. Başakşehir Çam & Sakura City Hospital · 2 drugs in this class
3. TriHealth Inc. · 2 drugs in this class
4. Centre of Postgraduate Medical Education · 2 drugs in this class
5. Bozyaka Training and Research Hospital · 2 drugs in this class
6. Complejo Hospitalario Universitario de Granada · 1 drug in this class
7. Clinique Saint-Jean, Bruxelles · 1 drug in this class
8. Hospital Clínico Universitario de Valencia · 1 drug in this class
9. Fundacion Clinica Valle del Lili · 1 drug in this class
10. Federal University of Minas Gerais · 1 drug in this class