The US Food and Drug Administration (USFDA) approved a higher number of generic drugs in FY25, which ended on September 30, than it did in the previous year, signalling a steady appetite for cost-saving medications.
The top-line numbers, however, mask a more complex reality for the industry's biggest players, particularly Indian pharmaceutical firms, which are navigating intensified regulatory scrutiny and significant delays in bringing approved products to market.
The FDA approvals are vital for India, which exported $10 billion worth of generic medicines to the United States in FY25, accounting for almost 35 percent of pharmaceutical exports.
In FY24, the agency approved 694 generic drugs to be sold in the United States, FDA data shows. With 602 full and tentative approvals recorded in the first 10 months of FY25, the agency is on track to reach approximately 700 approvals for the year. This is preliminary data and final figures are likely to change.
The FDA follows the October-September financial year.
The data for FY25, running through July, shows 602 total approvals. The pace has been inconsistent. August, for instance, was the slowest month of the fiscal year for approval actions. In September, the FDA granted at least 40 full approvals and four tentative approvals for Abbreviated New Drug Applications (ANDAs).
India still dominates
Indian pharmaceutical manufacturers are a dominant force in the US generic market, accounting for a substantial portion of all ANDA approvals.
Their share ranges from 35-45 percent of total ANDA approvals.
Despite this strong presence, Indian companies have encountered challenges.
The first quarter of FY25 saw increased scrutiny from the USFDA, leading to a temporary dip in their approval rates.
Many Indian drugmakers are pivoting their strategy, increasingly focusing on the development of more complex and specialty generic drugs to move away from saturated markets.
The Trump administration's trade policies have also been a key concern. US President Donald Trump's move to levy 100 percent tariffs on imported branded and patented pharmaceuticals is unlikely to significantly impact the bulk of India's drug exports, which are primarily simple generics.
A persistent trend complicating the generic landscape is the significant time lag between an ANDA approval and the drug's actual launch.
An IQVIA report analysing data from 2013 to early 2024 found that 37 percent of all approved generics were yet to be launched.
This delay can be substantial, with the report noting that it can take more than four years for 70 percent of generics to reach the market.
Market dynamics appear to be shifting, as smaller generic companies are now more likely to launch their approved products than their larger or mid-sized competitors.
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