Bupivacaine 0.5 % with Epinephrine — Competitive Intelligence Brief

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

marketed Local anesthetic with vasopressor Voltage-gated sodium channels Anesthesia Small molecule

Target snapshot

Bupivacaine 0.5 % with Epinephrine (Bupivacaine 0.5 % with Epinephrine) — Holy Cross Hospital, Florida. Bupivacaine blocks sodium channels in nerve cell membranes to produce local anesthesia, while epinephrine causes vasoconstriction to prolong the anesthetic effect and reduce systemic absorption.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Bupivacaine 0.5 % with Epinephrine TARGET	Bupivacaine 0.5 % with Epinephrine	Holy Cross Hospital, Florida	marketed	Local anesthetic with vasopressor	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)
Hyperbaric bupivacaine+Morphine	Hyperbaric bupivacaine+Morphine	Fundación Pública Andaluza Progreso y Salud	marketed	Local anesthetic + opioid combination	Voltage-gated sodium channels (bupivacaine); mu opioid receptors (morphine)
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 with vasopressor class)

1. Holy Cross Hospital, Florida · 2 drugs in this class
2. Lumbini Medical College · 1 drug in this class
3. Rush University Medical Center · 1 drug in this class
4. Universidad de Antioquia · 1 drug in this class
5. University of Aarhus · 1 drug in this class
6. University of Santiago de Compostela · 1 drug in this class