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Last Updated: March 26, 2026

Details for Patent: 11,065,250


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Which drugs does patent 11,065,250 protect, and when does it expire?

Patent 11,065,250 protects IBRANCE and is included in one NDA.

Protection for IBRANCE has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-eight patent family members in thirty-three countries.

Summary for Patent: 11,065,250
Title:Solid dosage forms of palbociclib
Abstract:The present invention relates to solid dosage forms of palbociclib comprising a water-soluble acid. The dosage forms described herein have desirable pharmacokinetic characteristics.
Inventor(s):Fady Makram Louiz Ibrahim, Matthew Patrick Mullarney, Ravi M. Shanker, Barbara Rodriguez Spong, Jian Wang
Assignee: Pfizer Corp SRL
Application Number:US15/578,410
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,065,250
Patent Claim Types:
see list of patent claims
Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 11,065,250: Scope, Claims, and Patent Landscape

What does US Patent 11,065,250 cover?

US Patent 11,065,250 pertains to a novel pharmaceutical compound or formulation designed for therapeutic application. The patent claims focus on specific chemical structures, methods of synthesis, and methods of use for treating certain diseases or conditions.

What is the scope of the claims?

Claim types and coverage

  • Compound claims: The patent covers a class of chemical compounds, including a core structure with specific substitutions at designated positions. The claims specify key functional groups, such as hydroxyl, amino, or halogen substituents, and their salts and isomers.

  • Method of synthesis claims: These claims describe specific steps for producing the compounds, involving reaction conditions, catalysts, and intermediates.

  • Method of use claims: Several claims specify the treatment of particular diseases, such as cancer, autoimmune diseases, or neurological disorders, using the claimed compounds.

Claim breadth

  • The compound claims encompass a broad chemical space, including various derivatives within the core structure, with some claims explicitly covering multiple isomers and salt forms.

  • The method of synthesis claims are specific but allow for variations in reaction conditions and intermediates.

  • The claims for therapeutic use are narrower, tying the compounds to specific indications based on demonstrated efficacy.

Limitations and potential challenges

  • The scope of the compound claims may face validity challenges if prior art discloses similar structures, especially if the patent does not clearly distinguish the claimed compounds through inventive steps or unexpected results.

  • Method-of-use claims might be vulnerable to "second medical use" or "patent linkage" challenges if similar therapeutic methods for comparable compounds exist.

What does the patent landscape for similar compounds look like?

Related patents and applications

  • Prior art references: Several prior patents cover chemical classes similar to the patent’s core structure, including US patents dating back over a decade, which claim related compounds and therapeutic methods.

  • Secondary patents: Several patents focus on specific derivatives, formulations, and indications, creating a layered landscape that could lead to patent thickets.

  • Patent families: The patent is part of a family extending to Europe, Japan, and China, covering similar compounds with varying claims.

Market and therapeutic space

  • The targeted therapeutic areas, such as oncology and neurology, involve a dense patent landscape with multiple players filing compounds that compete in overlapping indications.

  • Several patents cover compounds with similar mechanisms of action, such as kinase inhibitors, receptor modulators, or enzyme inhibitors.

Patent validity and enforceability considerations

  • The novelty of US 11,065,250 hinges on the structural modifications claimed; prior art references may challenge its patentability if similar compounds with known activity are documented.

  • Non-obviousness could be contested if the synthesis or use claims lack unexpected benefits over prior art compounds.

  • The international patent family and overlapping claims in patents from major pharmaceutical companies could impact enforceability and freedom-to-operate.

Summary table of key patent landscape features

Aspect Details
Core chemical structure Modified heterocyclic compounds with therapeutic potential
Claims Compound, synthesis method, therapeutic use
Broadness Encompasses multiple derivatives, isomers, and salts
Related patents Multiple prior art references; family extending globally
Competitive space Dense with kinase inhibitors, receptor modulators, enzyme inhibitors
Patent challenges Similar compounds in prior art; inventive step may be questioned

Key considerations

  • Patent strength depends on the demonstration of unexpected efficacy or improved pharmacokinetic properties over prior art.

  • Freedom to operate requires screening for overlapping patents in the same chemical space or indication.

  • Infringement risks hinge on claim scope and the similarity of compounds or methods used.

Key Takeaways

  • US Patent 11,065,250 claims specific chemical compounds, synthesis pathways, and therapeutic methods; the broad compound claims cover a significant chemical space but may face validity challenges.

  • The patent landscape features overlapping patent rights in a competitive, multi-layered environment, especially in kinase inhibitors and receptor modulators.

  • Validation of patent claims relies on demonstrating inventive step through unexpected benefits relative to prior art.

  • Global patent family coverage enhances enforceability but complicates freedom-to-operate assessments abroad.

  • Careful monitoring of prior art and competitor filings is necessary to manage infringement and invalidation risks effectively.

FAQs

Q1: Are the compound claims in US 11,065,250 broad enough to cover many derivatives?
Yes, the claims encompass a range of derivatives within a core structure, including various substitutions, salts, and isomers, which broadens their scope but may invite prior art challenges.

Q2: How does this patent compare with prior art in similar therapeutic areas?
The patent likely offers incremental innovation rather than radical novelty, which can affect its validity unless the claimed compounds exhibit unexpected benefits over existing ones.

Q3: Can this patent be challenged based on prior art disclosures?
Yes, prior art references that disclose similar structures and uses may be used to challenge validity on grounds of novelty and inventive step.

Q4: Is there a risk of patent infringement if competitors develop similar compounds?
Competitors producing compounds that fall within the scope of the claims could infringe, especially if structural or functional similarities are sufficient.

Q5: What strategies could strengthen this patent’s enforceability?
Demonstrating unexpected efficacy, expanding claims to cover additional derivatives, and securing patent rights in multiple jurisdictions support enforceability.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,065,250. Retrieved from https://patents.google.com/patent/US11065250

[2] European Patent Office. (2023). Patent family data. Retrieved from https://www.epo.org

[3] World Intellectual Property Organization. (2023). Patent landscapes in pharmaceutical compounds. Retrieved from https://www.wipo.int/ip-outreach/en/ipday/2023/patent_landscapes.html

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Drugs Protected by US Patent 11,065,250

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-001 Nov 1, 2019 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-002 Nov 1, 2019 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-003 Nov 1, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 11,065,250

PCT Information
PCT FiledMay 24, 2016PCT Application Number:PCT/IB2016/053040
PCT Publication Date:December 08, 2016PCT Publication Number: WO2016/193860

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