BioTech IP Review

• Patent Number: U.S. Patent No. 10,723,730
• Issue Date: July 28, 2020
• Filing Date: (Exact U.S. filing date isn’t publicly listed on the summary, but related applications date from the late 2010s and the issued patent reflects core composition/form claims critical to the drug’s exclusivity)
• Assignee: Pfizer Inc.
• Patent Expiry: February 8, 2034 (subject to term adjustments and extensions)
• Protected Subject: Crystalline free base and dosage formulations of palbociclib, which underpin the marketed drug Ibrance.

What This Patent Covers

Specific solid (crystalline) forms of palbociclib

• Defined polymorphs/crystal structures of palbociclib free base
• These forms have better stability, purity, and manufacturability than other possible forms

Pharmaceutical compositions containing those solid forms

• Tablets/capsules that use the claimed crystalline palbociclib
• Specific excipients and formulation ranges that make the drug usable at scale

Methods of preparing those solid forms

• How to crystallize palbociclib to obtain the protected polymorphs
• Processing conditions that reliably produce the commercial form

Why This Patent is Important

• Major Revenue Driver: Ibrance (palbociclib) generated several billion dollars in revenue for Pfizer in 2023, making it one of the company’s top oncology products that helped sustain Pfizer’s overall sales mix outside of vaccines and antivirals.
• Commercial Exclusivity: The 10,723,730 patent — covering key solid forms and compositions — provided long-term rights to market Ibrance without generic competition until the mid-2030s, securing high-margin revenue through extended patent protection.
• Strategic Importance: Oncology is a core growth area for Pfizer, and Ibrance’s sustained exclusivity via this patent helped support the company’s investments and positioning in the competitive cancer therapy space.

Summary

The U.S. Patent No. 10,723,730 for solid forms of palbociclib was arguably Pfizer’s most commercially important patent due to its role in protecting the Ibrance franchise — a high-revenue oncology drug that remains central to Pfizer’s financial performance and competitive standing.