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Filings seeking US Food and Drug Administration approvals to launch generic drugs in the US have picked up pace in the nine months to June 2026, with Indian drugmakers estimated to account for roughly half of the fresh filings. According to Nomura, global pharma companies filed 457 ANDAs (Abbreviated New Drug Applications) between October 2025 and June 2026, compared with 393 in the same period a year earlier, representing a 16.3% jump.
“After a material slowdown in ANDA filings in FY25 (year ended September 2025), the filing rate has increased in FY26 thus far,” the brokerage said in a report.
The rise in the ANDA filings comes in the backdrop of likely 100-200% US tariffs on imported generics from 2028, which would normally be expected to discourage drugmakers from filing for new products in the market. The increase in filings is particularly notable as drugmakers are now focusing on complex generics – a space where high entry barriers can limit competition and improve commercial returns.
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The official data shows that US FDA approved 689 ANDAs in FY2025, while 600 ANDAs were submitted during the year. Out of these submissions, 100 were classified as complex products. Nomura has also estimated that 15-20% of ANDAs were classified as complex product filings in the recent past.
To be sure, an ANDA is the regulatory submission through which a drugmaker seeks US approval for a generic medicine. Unlike an New Drug Application (NDA), which requires extensive clinical and preclinical evidence for a new drug, an ANDA generally relies on demonstrating that the generic is bioequivalent to an already approved reference drug. The abbreviated route allows companies to avoid repeating the full clinical development programme required for a new medicine.
The recent increase in applications comes after ANDA filings fell to a 20-year low in FY25 as drugmakers globally became more selective about the products they want to develop.
Experts said that the growth in filings is primarily driven by smaller emerging companies who are sensing opportunities in the US market despite their smaller base. “Larger players have kept their filing activity broadly flat over the past three to four years and are prioritising products where development barriers are higher,” said Vishal Manchanda, senior vice president (institutional research), Systematix Group.
Even though traditional generics have become a scale-and-volume game marked by intense competition and sustained price erosion, complex generics generally operate differently because they have a bigger scope for differentiation and stronger commercial potential.
The commercial opportunity from differentiated generics can be strong. Nomura noted that Alembic Pharma had 180 days of sole exclusivity for generic bosutinib, the generic version of Bosulif, which has an annual market of about $300 million. The company had a 63% market share in July.
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According to Amit Misra, managing director (healthcare and lifesciences) at Alvarez & Marsal India, complex products such as inhalers, peptide injectables, long-acting injectables and liposomal oncology therapies require specialised development capabilities, sophisticated manufacturing and, in some cases, device equivalence with the reference product. “These higher technical and regulatory barriers limit the number of credible competitors, allowing pricing to remain more resilient and each approval to generate greater lifetime value. This is why complex generics are attracting increasing strategic focus and investment,” he said.
TOPICSpharmaceuticalsThis article was first uploaded on September seventeen, twenty twenty-six, at five minutes past eight in the night. © The Indian Express (P) Ltd