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Sodium hyaluronate 0.4%
Sodium hyaluronate 0.4%, marketed by Laboratorios Sophia S.A de C.V., holds a position in the ophthalmic market with a key composition patent expiring in 2028. The drug's primary strength lies in its established market presence and the protective patent, which secures its exclusivity until 2028. The primary risk is the potential increase in competition post-patent expiry, which could impact revenue.
At a glance
| Generic name | Sodium hyaluronate 0.4% |
|---|---|
| Also known as | Lagricel Ofteno® PF, PRO-037 |
| Sponsor | Laboratorios Sophia S.A de C.V. |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution as Treatment for Dry Eye Disease. (PHASE2)
- Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye. (PHASE4)
- Effects of Intra-articular Hypertonic Dextrose and Hyaluronic Acid on Primary Knee Osteoarthritis. (PHASE3)
- Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4% (PHASE3)
- A Post-market Study to Evaluate the Effects of Sodium Hyaluronate Based Eye Drops in Patients Affected by Dry Eye Disease (NA)
- Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections (NA)
- Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF (PHASE1)
- Phase IV Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo After Photorefractive Keratectomy (PRK) (PHASE4)
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:
- Sodium hyaluronate 0.4% CI brief — competitive landscape report
- Sodium hyaluronate 0.4% updates RSS · CI watch RSS
- Laboratorios Sophia S.A de C.V. portfolio CI