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Septocaine (ARTICAINE)
Septocaine (generic name: ARTICAINE) is a Amide Local Anesthetic Small molecule drug developed by Am Genomics. It is currently FDA-approved (first approved 2000) for Local, Infiltrative, or Conductive Anesthesia.
Articaine HCl blocks nerve impulses by increasing the threshold for electrical excitation, slowing nerve impulse propagation, and reducing the rate of rise of the action potential.
Articaine, marketed as Septocaine, is a local anesthetic currently in use for infiltrative or conductive anesthesia, holding a significant position in the dental and surgical markets. Its key strength lies in its mechanism of action, which effectively blocks nerve impulses by increasing the threshold for electrical excitation and slowing nerve impulse propagation, offering rapid onset and a favorable safety profile. The primary risk to Articaine's market position is the expiration of its key composition patent in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | ARTICAINE |
|---|---|
| Sponsor | Am Genomics |
| Drug class | Amide Local Anesthetic |
| Target | Sodium channel alpha subunits; brain (Types I, II, III) |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2000 |
Mechanism of action
Articaine HCl works as a local anesthetic by interfering with the normal function of nerves. It increases the threshold needed to trigger a nerve impulse, slows down the speed at which the impulse travels, and reduces the speed at which the nerve cell can generate an impulse. This leads to a loss of sensation in the area where it is applied.
Approved indications
- Local, Infiltrative, or Conductive Anesthesia
Common side effects
- Face edema
- Headache
- Infection
- Pain
- Gingivitis
- Paresthesia
- Any adverse event
- Pain
- Headache
- Positive blood aspiration into syringe
- Swelling
- Trismus
Drug interactions
- monoamine oxidase inhibitors
- nonselective beta-adrenergic antagonists
- tricyclic antidepressants
- phenothiazines
- butyrophenones
- nitrates/nitrites (e.g., nitric oxide, nitroglycerin, nitroprusside, nitrous oxide)
- local anesthetics (e.g., articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, ropivacaine, procaine, tetracaine)
- antineoplastic agents (e.g., cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase)
- antibiotics (e.g., dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides)
- antimalarials (e.g., chloroquine, primaquine)
- anticonvulsants (e.g., phenobarbital, phenytoin, sodium valproate)
- other drugs (e.g., acetaminophen, metoclopramide, quinine, sulfasalazine)
Key clinical trials
- Effects of Local Ketamine in Orthognathic Procedures (NA)
- Radiographic and Histological Assessment of GBR Using DBB Compared to Spontaneous Bone Regeneration of Maxillary Defects , Resulted From Enucleation of Intra-bony Cystic Lesions (NA)
- Management of Excess Gingival Display Using Tunnel Technique With 3D Designed PEEK Shell: A Case Series (NA)
- Clinical Outcomes of Mandibular Primary Molar Extraction Using Physics Forceps in Children (NA)
- Magnetic Mallet and Piezotome in Atrophic Anterior Maxillary Ridge Expansion With Simultaneous Bone Graft and Implant Placement ( (NA)
- Comparison of Anesthetic Efficacy OF 2% Lidocaine Inferior Alveolar Nerve (IANB) Block Versus Primary Buccal Infilteration With 4% Articaine in Symptomatic Irreversible Pulpitis(SIP) IN Mandibular First Molars (NA)
- The Impact of Nitrous Oxide Sedation on Dental Fear and Anxiety Scores in Children Aged 6-10 Years (PHASE2)
- 'Propolis Versus Chlorhexidine Gluconate on Wound Healing After Third Molar Surgery: a Randomized Controlled Trial' (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Septocaine CI brief — competitive landscape report
- Septocaine updates RSS · CI watch RSS
Frequently asked questions about Septocaine
What is Septocaine?
How does Septocaine work?
What is Septocaine used for?
Who makes Septocaine?
What is the generic name of Septocaine?
What drug class is Septocaine in?
When was Septocaine approved?
What development phase is Septocaine in?
What are the side effects of Septocaine?
What does Septocaine target?
Related
- Drug class: All Amide Local Anesthetic drugs
- Target: All drugs targeting Sodium channel alpha subunits; brain (Types I, II, III)
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Local, Infiltrative, or Conductive Anesthesia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing