Whalesbook
Indian drugmakers' filings for U.S. Abbreviated New Drug Applications (ANDAs) have plunged to their lowest in two decades, according to a Nomura report analyzing sales and prescription data. The report cites 600 ANDA submissions in the financial year 2025, down from 740 in the previous year, signaling a strategic shift by the industry.
Strategic Selectivity
The sharp decline in new drug applications suggests Indian pharmaceutical companies are becoming highly selective in their product development pipeline for the U.S. market. With approximately 17% of total filings classified as complex, firms are focusing efforts on higher-value or more challenging generic products.
Stable Approvals Mask Filing Decline
Despite the dip in new submissions, the rate of final drug approvals has remained largely stable. Nomura observed 689 final approvals in FY2025, a marginal decrease from 694 in the prior year. Nearly 20% of these approvals were achieved within the first cycle, indicating continued efficiency in the review process.
Divergent US Sales Performance
Analysis of U.S. market sales revealed a varied performance among major Indian players in the three months leading up to November 2025. Lupin recorded substantial growth, with U.S. sales surging 90% year-on-year to $488 million, boosted by a new drug launch. Sales of its generic Jynarque tablets alone increased by 62% to $62 million.
Cipla followed as the second-highest U.S. sales generator among Indian firms, posting a 55% rise to $303 million. However, the landscape was different for others. Biocon experienced a steep 59% year-on-year decline in U.S. sales, falling to $305 million, attributed to changes in the mix of branded versus unbranded product versions.
Dr. Reddy's Laboratories also reported a significant 28% year-on-year drop in U.S. sales, primarily driven by an expected decline in its generic Revlimid and a lack of recent product launches.