Hyperbaric bupivacaine+Sufentanil — Competitive Intelligence Brief

Hyperbaric bupivacaine+Sufentanil (Hyperbaric bupivacaine+Sufentanil) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Local anesthetic + opioid combination. Area: Anesthesia.

marketed Local anesthetic + opioid combination Voltage-gated sodium channels (bupivacaine); mu-opioid receptors (sufentanil) Anesthesia Small molecule

Target snapshot

Hyperbaric bupivacaine+Sufentanil (Hyperbaric bupivacaine+Sufentanil) — Fundación Pública Andaluza Progreso y Salud. Bupivacaine blocks sodium channels in nerve fibers to produce local anesthesia, while sufentanil is an opioid agonist that enhances analgesia through mu-receptor activation; the hyperbaric formulation increases density for spinal distribution.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Hyperbaric bupivacaine+Sufentanil TARGET	Hyperbaric bupivacaine+Sufentanil	Fundación Pública Andaluza Progreso y Salud	marketed	Local anesthetic + opioid combination	Voltage-gated sodium channels (bupivacaine); mu-opioid receptors (sufentanil)
Bupivacaine + Sufentanil epidural	Bupivacaine + Sufentanil epidural	Charles University, Czech Republic	marketed	Local anesthetic + opioid combination	Voltage-gated sodium channels (bupivacaine); mu opioid receptor (sufentanil)
Levobupivacaine plus sufentanil epidural infusion	Levobupivacaine plus sufentanil epidural infusion	University of Genova	marketed	Local anesthetic + opioid combination	Voltage-gated sodium channels (levobupivacaine); mu-opioid receptor (sufentanil)
Bupivacaine heavy and Morphine	Bupivacaine heavy and Morphine	Post Graduate Institute of Medical Education and Research, Chandigarh	marketed	Local anesthetic + opioid combination	Voltage-gated sodium channels (bupivacaine); mu-opioid receptor (morphine)
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)
Levobupivacaine 0.07% + Sufentanil 0.3µg/ml	Levobupivacaine 0.07% + Sufentanil 0.3µg/ml	Dr Madeleine Wilwerth	phase 3	Local anesthetic + opioid combination	Voltage-gated sodium channels (levobupivacaine); mu opioid receptor (sufentanil)
Levobupivacaine 0.1% + Sufentanil 0.2µg/ml	Levobupivacaine 0.1% + Sufentanil 0.2µg/ml	Dr Madeleine Wilwerth	phase 3	Local anesthetic + opioid combination	Voltage-gated sodium channels (levobupivacaine); mu opioid receptor (sufentanil)

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 + opioid combination class)

1. Dr Madeleine Wilwerth · 2 drugs in this class
2. Fundación Pública Andaluza Progreso y Salud · 2 drugs in this class
3. Charles University, Czech Republic · 1 drug in this class
4. Post Graduate Institute of Medical Education and Research, Chandigarh · 1 drug in this class
5. University of Genova · 1 drug in this class