Bupivacaine Hcl 0.5% Inj — Competitive Intelligence Brief

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

marketed Local anesthetic Voltage-gated sodium channels Anesthesia Small molecule

Target snapshot

Bupivacaine Hcl 0.5% Inj (Bupivacaine Hcl 0.5% Inj) — Hospital for Special Surgery Florida. Bupivacaine is a local anesthetic that blocks sodium channels in nerve cell membranes, preventing the initiation and conduction of nerve impulses.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Bupivacaine Hcl 0.5% Inj TARGET	Bupivacaine Hcl 0.5% Inj	Hospital for Special Surgery Florida	marketed	Local anesthetic	Voltage-gated sodium channels
Propofol/Lidocaine	Propofol/Lidocaine	NYU Langone Health	marketed	Intravenous anesthetic combination	GABA-A receptor (propofol); voltage-gated sodium channels (lidocaine)
Exparel TAP + multi-modal pain regimen	Exparel TAP + multi-modal pain regimen	Pacira Pharmaceuticals, Inc	marketed	Local anesthetic (liposomal formulation)	Voltage-gated sodium channels
Bupivacaine-fentanyl elective group	Bupivacaine-fentanyl elective group	Conrad Arnfinn Bjørshol	marketed	Local anesthetic with opioid analgesic combination	Voltage-gated sodium channels (bupivacaine); mu opioid receptor (fentanyl)
Control (bupivacaine)	Control (bupivacaine)	Kasr El Aini Hospital	marketed	Local anesthetic (amide)	Voltage-gated sodium channels
ropivacaine and ketorolac	ropivacaine and ketorolac	University of Aarhus	marketed	Local anesthetic + NSAID combination	Voltage-gated sodium channels (ropivacaine); COX-1 and COX-2 (ketorolac)
carbamazepine ER (Equetro)	carbamazepine ER (Equetro)	Massachusetts General Hospital	marketed	Anticonvulsant; mood stabilizer	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 class)

1. University of California, San Diego · 3 drugs in this class
2. Durect · 3 drugs in this class
3. Pacira Pharmaceuticals, Inc · 3 drugs in this class
4. Wake Forest University Health Sciences · 3 drugs in this class
5. Medical University of Vienna · 3 drugs in this class
6. Imperial College London · 2 drugs in this class
7. Hvidovre University Hospital · 2 drugs in this class
8. Innocoll · 2 drugs in this class
9. George Washington University · 2 drugs in this class
10. Guy's and St Thomas' NHS Foundation Trust · 2 drugs in this class