Hikma announces settlement agreement for VYNDAMAX® (tafamidis)
London, 28 April 2026 – Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (Hikma) announces that it has entered into a settlement agreement with Pfizer Inc. regarding Hikma’s Abbreviated New Drug Application (ANDA) to bring to market a generic version of VYNDAMAX® (tafamidis), a medicine used to treat adults with cardiomyopathy transthyretin-mediated amyloidosis (ATTR-CM). The settlement agreement allows Hikma to enter the market with its generic tafamidis on 1 June 2031. This is ahead of the 31 August 2035 expiry date of the patent challenged by Hikma.
“This settlement is a great example of how we are successfully executing our first-to-file strategy and translating this into meaningful, value-creating opportunities within our pipeline,” said Hafrun Fridriksdottir, President, Hikma US and Chief R&D Officer. “By resolving the litigation, we now have a clear pathway to ensuring earlier and more affordable access for patients to this important medicine.”
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About Hikma Pharmaceuticals PLC
Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,400 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com
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