Merck Races to Launch Subcutaneous Keytruda Amid Looming Patent Expiry for IV Version

Merck accelerates subcutaneous Keytruda rollout to protect cancer drug's dominance as IV patent nears 2028 expiry.

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Jan 14, 2025
Summary
  • Merck plans 2025 launch of subcutaneous Keytruda to extend patent protection, following strong Phase 3 trial results.
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In extending patent protection for its primary cancer medication, Keytruda, Merck (MRK, Financial) intends to introduce a subcutaneous form of it this year. It's important to also note that Merck is getting ready for U.S. patent exclusivity for the intravenous form of Keytruda to expire in 2028.

A pillar of Merck's portfolio, Keytruda, sometimes known as pembrolizumab, brought in $21.6 billion in income in the first nine months of 2024, or around 45% of the company's entire income. CEO Robert Davis underlined at the JPMorgan Healthcare Conference the faster schedule for the new formulation. "We now expect to file, have approval, and launch our subcutaneous pembrolizumab in 2025," Davis added, stressing the importance of this advancement.

Merck said in November that in a Phase 3 trial against the intravenous formulation, the subcutaneous Keytruda version proved effective. The company intends to interact with international authorities to get clearance for the medication for several cancer indications.

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