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Hifenac (ACECLOFENAC)
Aceclofenac (Hifenac) is a marketed nonsteroidal anti-inflammatory drug (NSAID) primarily indicated for adhesive capsulitis of the shoulder, competing in a crowded NSAID market with several off-patent generics and patent-protected alternatives. Its key strength lies in its mechanism of action, which effectively inhibits prostaglandin production to reduce pain and inflammation, potentially offering a differentiated efficacy profile compared to older NSAIDs. The primary risk is the expiration of its key composition patent in 2028, which could lead to increased competition from generics and erode market share.
At a glance
| Generic name | ACECLOFENAC |
|---|---|
| Drug class | aceclofenac |
| Target | Transthyretin |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
- Adhesive capsulitis of shoulder
- Ankylosing spondylitis
- Backache
- Osteoarthritis
- Rheumatoid arthritis
Common side effects
- Dyspepsia
- Abdominal pain
- Nausea
- Rash
- Urticaria
- Headache
- Dizziness
- Drowsiness
- Ruber
- Enuresis
Key clinical trials
- Effects of App-assisted Home Exercise Program in Patients With Frozen Shoulder (NA)
- Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Ilaprazole and Aceclofenac (PHASE1)
- Bioequivalence Study of Two Formulations of Tablets Aceclofenac 100 mg in Healthy Volunteers Under Fasting Conditions (PHASE1)
- Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Naproxen, Aceclofenac, Celecoxib and Ilaprazole (PHASE1)
- Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain (NA)
- Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation (NA)
- Compare Pharmacokinetics and Safety of JP-1366 Between Korean and Caucasian (PHASE1)
- Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers (PHASE1)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hifenac CI brief — competitive landscape report
- Hifenac updates RSS · CI watch RSS