Isobaric bupivacaine 0.5% — Competitive Intelligence Brief

Isobaric bupivacaine 0.5% (Isobaric 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

Isobaric bupivacaine 0.5% (Isobaric bupivacaine 0.5%) — Hospital Clínico Universitario de Valencia. Isobaric bupivacaine blocks sodium channels in nerve fibers to produce local anesthesia with a specific gravity matching cerebrospinal fluid.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Isobaric bupivacaine 0.5% TARGET	Isobaric bupivacaine 0.5%	Hospital Clínico Universitario de Valencia	marketed	Local anesthetic (amide class)	Voltage-gated sodium channels
Propofol/Lidocaine	Propofol/Lidocaine	NYU Langone Health	marketed	Intravenous anesthetic combination	GABA-A receptor (propofol); voltage-gated sodium channels (lidocaine)
Dexamethasone+ Bupivacaine	Dexamethasone+ Bupivacaine	Ain Shams University	marketed	Corticosteroid + Local anesthetic combination	Glucocorticoid receptor (dexamethasone); Voltage-gated sodium channels (bupivacaine)
intraarticular injection with ropivacaine	intraarticular injection with ropivacaine	Hvidovre University Hospital	marketed	Local anesthetic	Voltage-gated sodium channels
Control (bupivacaine)	Control (bupivacaine)	Kasr El Aini Hospital	marketed	Local anesthetic (amide)	Voltage-gated sodium channels
Exparel/bupivacaine mixture	Exparel/bupivacaine mixture	Wake Forest University Health Sciences	marketed	Local anesthetic (liposomal formulation)	Voltage-gated sodium channels
Bupivacaine Liposomes(BL)	Bupivacaine Liposomes(BL)	Huazhong University of Science and Technology	marketed	Local anesthetic (liposomal formulation)	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