21 hrs ago
US Generic Drug Filings Rise Despite Looming Tariff Threat
Drug companies are asking the US government for permission to sell more generic medicines.
They submitted 457 applications in the nine months through June 2026, which was more than during the same period the year before.
Indian drugmakers may have made about half of these new applications.
This happened even though the United States may place very high tariffs on imported generic drugs starting in 2028.
Tariffs could make it more expensive to sell these medicines in America.
Many companies are focusing on complex generics, which are harder to make than ordinary generics.
Because fewer companies can make them, complex generics may face less competition and earn more money.
Smaller drugmakers appear to be driving much of the increase, while larger companies are focusing on products that are difficult to develop.
Global pharmaceutical companies filed 457 US generic-drug applications from October 2025 through June 2026, up 16.3% from 393 a year earlier.
Indian drugmakers are estimated to have accounted for roughly half of the new filings.
The increase comes despite possible US tariffs of 100-200% on imported generics from 2028.
Drugmakers are increasingly targeting complex generics, including inhalers, injectables and liposomal oncology therapies, which face higher entry barriers.
Nomura cited Alembic Pharma’s generic bosutinib as an example of the potential returns, with 180 days of exclusivity and a 63% market share in July.
- Who
- Global pharmaceutical companies, including Indian drugmakers and smaller emerging companies.
- What
- US filings for approval of generic drugs rose to 457 in the nine months through June 2026.
- Where
- The United States generic-drug market.
- When
- From October 2025 through June 2026; possible tariffs are expected from 2028.
- Why
- Companies are pursuing opportunities in complex generics, which can face less competition and offer stronger commercial returns.
Tariff and Competition Concerns
Complex-Drug Opportunity
Impact of potential tariffs
Tariff and Competition Concerns
Possible 100-200% US tariffs on imported generics from 2028 would normally discourage companies from filing new products.
Complex-Drug Opportunity
The continued rise in filings suggests some drugmakers still see sufficient opportunity in the US market despite the tariff threat.
Where companies are focusing
Tariff and Competition Concerns
Traditional generics are exposed to intense competition, scale pressures and continuing price erosion.
Complex-Drug Opportunity
Complex generics have higher technical and regulatory barriers, potentially limiting competition and supporting stronger pricing and returns.
Large versus smaller drugmakers
Tariff and Competition Concerns
Larger pharmaceutical companies have kept filing activity broadly flat and are being selective about new products.
Complex-Drug Opportunity
Smaller emerging companies are driving much of the recent growth by pursuing opportunities despite their smaller operating base.
Key facts
- Recent filings
- 457 Abbreviated New Drug Applications were filed from October 2025 through June 2026.
- Year-on-year change
- Filings increased 16.3% from 393 in the comparable period a year earlier.
- Estimated Indian share
- Indian drugmakers are estimated to account for roughly half of the fresh filings.
- Potential tariffs
- The United States may impose 100-200% tariffs on imported generics from 2028.
- FY2025 approvals
- The US Food and Drug Administration approved 689 generic-drug applications in FY2025.
- FY2025 submissions
- Drugmakers submitted 600 applications in FY2025, including 100 classified as complex products.
- Bosutinib example
- Alembic Pharma had 180 days of exclusivity for generic bosutinib and a 63% market share in July.
Quotes
Vishal Manchanda
Senior vice president of institutional research at Systematix Group
“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”
financialexpress.com
“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”
financialexpress.com
Sources
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