Exclusive Summary

• Pregabalin's core patents have expired in all major markets (US since 2018, Europe 2017-2019), enabling direct entry into mature generic markets backed by FDA and PH-FDA certifications.
• With over 300 million neuropathic pain patients globally and diabetic peripheral neuropathy affecting ~50% of 537 million diabetics worldwide, the addressable patient population is massive and growing.
• Pregabalin holds Grade A / first-line recommendation status in AAN, EAN, and multiple national neuropathic pain guidelines, ensuring stable and predictable prescription demand.
• Existing registrations in the US, Philippines, Singapore, and Taiwan provide a ready-to-distribute foundation, reducing time-to-market for distribution partners in these key markets.
• Chinese manufacturing cost structure is significantly lower than the originator (Pfizer Lyrica) and competitive against Indian generics, offering distribution partners strong margin potential especially in price-sensitive emerging markets.