Expiry of Rs 12k cr patented US drugs a big opportunity for pharma
Chennai: The US will see expiry of drugs worth Rs 12000 crore between 2025 and 2028 and this will be a huge opportunity for Indian generic drug manufacturers. This along with the current drug shortage will support the revenue growth of pharma companies in the coming years.
The top 10 patented drugs getting expired in the coming years in the US, include Pembrolizumab, sold under the brand name Keytruda by Merck and Co., Eliquis (Apixaban) sold by Bristol Myers Squibb and Pfizer, Eylea sold by Regeneron and Bayer, Bristol Myers Squibb’s Opdivo (nivolumab), Palbociclib, sold under the brand name Ibrance by Pfizer, Xarelto (Rivaroxaban) by Bayer and J&J, Trulicity by Eli Lilly, Pfizer’s Prevnar 13, Ocrelizumab, sold under the brand name Ocrevus by Roche, and Prolia/XgevaIt (Denosumab) sold by Amgen.
The US accounts for around 48 per cent of the global pharmaceutical spending and has always been a key market for most leading Indian pharmaceutical companies as well, accounting for a sizable 33-35 per cent share of their revenues.
The pricing pressure in the US has eased over the last three-four quarters, to mid-to-high single digit levels by Q2 FY2025 due to increasing drug shortages, thus supporting the revenue growth of generic pharmaceutical companies.
Increasing product shortages in the US have supported revenues of generic companies to some extent during FY2024 and FY2025, by way of higher volume growth and better pricing opportunities, finds ICRA.
According to it, the revenue growth from the US market for the key pharma exporters will grow by 9-11 per cent in FY2025, a moderation from the 18.3 per cent increase witnessed in FY2024 due to the high base. They had witnessed a growth of 12.5 per cent in revenues from the US market in H1 FY2025.
However, high incidences of warning letters and import alerts by the United States Food & Drug Administration (USFDA) remain a key credit risk. These not only lead to delays in product launches, but also failure in supplying penalties and the incurring of additional costs towards remedial measures, thus impacting revenue growth and profit margins.
Pharma companies have taken several measures to combat various US market-related risks. These include optimisation of product portfolio, cost saving measures and increased focus on complex molecules including injectables, inhalations, specialty products and biosimilars.
