Exclusive Summary

• - Massive global musculoskeletal and osteoarthritis burden (MSK ~1.71B, OA ~528M); NSAIDs are first-line analgesics and the CR profile improves adherence and steady pain control.
• - Core substance IP largely expired and the drug is not mainstream in US/EU, leaving room for first-entry and differentiation in many emerging markets.
• - KR MFDS GMP and local registration provide solid compliance credentials; CTD dossier and BE/bioperformance support are available for cross-border filings.
• - Clinical data show non-inferior efficacy versus celecoxib/traditional NSAIDs with favorable GI tolerability; CR 45 mg BID reduces dosing frequency and peak–trough swings.
• - As originator direct supply, pricing can be set competitively versus premium NSAIDs (e.g., coxibs) with flexible distribution models.

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