Bupivacaine HCl 0.5% Injectable Solution — Competitive Intelligence Brief

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

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

Target snapshot

Bupivacaine HCl 0.5% Injectable Solution (Bupivacaine HCl 0.5% Injectable Solution) — Bozyaka Training and Research Hospital. Bupivacaine blocks sodium channels in nerve cell membranes, preventing the initiation and conduction of nerve impulses to produce local anesthesia.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Bupivacaine HCl 0.5% Injectable Solution TARGET	Bupivacaine HCl 0.5% Injectable Solution	Bozyaka Training and Research Hospital	marketed	Local anesthetic (amide)	Voltage-gated sodium channels
Lidocaine skin wheal	Lidocaine skin wheal	George Washington University	marketed	Local anesthetic	Voltage-gated sodium channels
Lidoderm 5 % Topical Patch	Lidoderm 5 % Topical Patch	Oregon Health and Science University	marketed	Local anesthetic	Voltage-gated sodium channels
PIB 0.2% ropivacaine	PIB 0.2% ropivacaine	University Health Network, Toronto	marketed	Local anesthetic (amide class)	Voltage-gated sodium channels
etomidate, fentanyl, and lidocaine	etomidate, fentanyl, and lidocaine	Drexel University College of Medicine	marketed	Anesthetic combination (hypnotic + opioid + local anesthetic)	GABA-A receptor (etomidate), mu opioid receptor (fentanyl), voltage-gated sodium channels (lidocaine)
Dyclonine hydrochloride mucilage	Dyclonine hydrochloride mucilage	Peking Union Medical College Hospital	marketed	Local anesthetic	Voltage-gated sodium channels
Lidocaine-Prilocaine Cream 2.5-2.5%	Lidocaine-Prilocaine Cream 2.5-2.5%	Centre Hospitalier le Mans	marketed	Local anesthetic	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)

1. Poznan University of Medical Sciences · 4 drugs in this class
2. Nantes University Hospital · 3 drugs in this class
3. Bozyaka Training and Research Hospital · 2 drugs in this class
4. ASST Gaetano Pini-CTO · 2 drugs in this class
5. Centre Hospitalier Universitaire de Nīmes · 1 drug in this class
6. Chiang Mai University · 1 drug in this class
7. Beijing Tiantan Hospital · 1 drug in this class
8. Complejo Hospitalario Universitario de Granada · 1 drug in this class
9. Ciusss de L'Est de l'Île de Montréal · 1 drug in this class
10. China Medical University, China · 1 drug in this class