Exclusive Summary

• • Off-patent in most major markets (EU since 2014, US since 2019, JP since 2020), enabling rapid generic entry and scale-up.
• • Large addressable population across neuropathic pain, fibromyalgia, and adjunctive epilepsy; 75/150 mg align with standard titration and hospital demand.
• • Endorsed as first-/co-first-line for neuropathic pain by major guidelines, with EU GAD label providing incremental growth.
• • API meets BP/USP/EP and TT is available; localization plus compliant (serialized/controlled) supply chains improve access and tender success.
• • Prices typically 80–95% below originator; LMIC daily therapy cost around USD 0.10–0.50 supports strong cost-effectiveness.