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Lioresal (BACLOFEN)
Lioresal (Baclofen) is a small molecule gamma-Aminobutyric Acid-ergic Agonist that targets the GABA-B receptor. Originally developed by, it was FDA approved in 1977 for the treatment of muscle spasticity of cerebral and spinal origin. The drug is now owned by Novartis and is available as a generic medication, with 27 generic manufacturers. Lioresal has a half-life of 5.24 hours and a bioavailability of 90%. It is off-patent, with no active Orange Book patents.
At a glance
| Generic name | BACLOFEN |
|---|---|
| Sponsor | Novartis |
| Drug class | gamma-Aminobutyric Acid-ergic Agonist [EPC] |
| Target | GABA-B receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1977 |
Approved indications
- Muscle Spasticity of Cerebral Origin
- Muscle spasticity of spinal origin
Common side effects
- Transient drowsiness
- Dizziness
- Weakness
- Fatigue
- Nausea
- Confusion
- Headache
- Insomnia
- Urinary frequency
- Constipation
- Hypotension
- Dyspnea
Drug interactions
- sodium oxybate
Key clinical trials
- Baclofen for Children With Rumination Syndrome (PHASE3)
- The Analgesic Efficacy and Safety of Baclofen in Patients With Herpes Zoster (NA)
- Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence (PHASE2,PHASE3)
- Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers (PHASE2,PHASE3)
- Multiprofen-CC to Reduce Pain in Hand Arthritis (PHASE3)
- Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge (PHASE2)
- Phone-based Safety Monitoring of Baclofen Prescriptions for Alcohol Use Disorder (PHASE4)
- Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 11850225 | 2041-09-29 | Formulation |
| 10792262 | 2039-07-29 | Formulation |
| 11446246 | 2037-09-08 | Method of Use |
| 11491125 | 2041-09-29 | Formulation |
| 10610502 | 2039-08-30 | Method of Use |
| 11654124 | 2039-07-29 | Formulation |
| 11931328 | 2039-07-29 | Formulation |
| 11324696 | 2037-09-29 | Formulation |
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:
- Lioresal CI brief — competitive landscape report
- Lioresal updates RSS · CI watch RSS