Pfizer announces USPTO issue US patent term extension for Ibrance until March 2027

Pfizer Inc. announced that the US Patent and Trademark Office (USPTO) recently issued a US Patent Term Extension (PTE) certificate for Ibrance (palbociclib). The certificate extends the term of US Patent No. RE47,739 (‘739) by more than four years until March 5, 2027. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984.

This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the US Food and Drug Administration (FDA). This extension does not include potential pediatric exclusivity.

Ibrance is an oral inhibitor of CDKs 4 and 6, which are key regulators of the cell cycle that trigger cellular progression. In the US, Ibrance is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy.

Ibrance is currently approved in more than 100 countries and has been prescribed to more than 350,000 patients globally.

Pfizer Oncology committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer.



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