US ANDA Analysis – Overview

This dashboard provides a snapshot of Abbreviated New Drug Application (ANDA) activity, highlighting approval trends, market participation, and product-wise concentration. The data reflects strong engagement from global manufacturers—especially India and the United States—and indicates active competition across key therapeutic categories.

Overall Snapshot

Reference Listed Drugs (RLDs) analyzed: 36

Total ANDA applications: 259

Average approval time: 45 days

Pending applications: 13

Participating countries: 17

The numbers show a high level of generic filing activity with relatively quick turnaround times, reflecting strong alignment between applicants and regulatory expectations.

Top Product Applications

Prucalopride Succinate: 26 applications

Sacubitril & Valsartan: 9 applications

Famotidine: 7 applications

Prucalopride Succinate clearly leads the list, signaling high market interest and strong competition around this gastrointestinal therapy segment.

Country-Level Participation

India: 116 applications

United States: 89 applications

China: 17 applications

India dominates ANDA submissions, contributing nearly half of all applications. The U.S. follows closely, reflecting strong domestic generic development.

Companies With the Most Applications

Annora Pharma Pvt. Ltd.:  11 applications

Aurobindo Pharma Ltd.: 8 applications

Macleods Pharmaceuticals Ltd.: 8 applications

These companies emerge as key players in ANDA activity, actively expanding their generic portfolios and strengthening their U.S. market presence.

Key Insights for Stakeholders

The current ANDA landscape underscores a highly competitive environment driven largely by Indian and U.S. manufacturers. Fast approval timelines combined with high product application volumes—especially for Prucalopride Succinate—indicate an accelerated push toward generic availability. Companies with consistent filing patterns, such as Annora and Aurobindo, stand to benefit from early market entry and wider portfolio diversification.

Overall, the data reflects a dynamic and fast-moving ANDA ecosystem, offering clear opportunities for strategic planning, competitive intelligence, and market positioning.