Details for Patent: 10,464,905

Which drugs does patent 10,464,905 protect, and when does it expire?

Patent 10,464,905 protects JAYPIRCA and is included in one NDA.

This patent has seventy-five patent family members in thirty-eight countries.

Summary for Patent: 10,464,905

Title:	Compounds useful as kinase inhibitors
Abstract:	This invention relates to novel compounds. The compounds of the invention are tyrosine kinase inhibitors. Specifically, the compounds of the invention are useful as inhibitors of Bruton's tyrosine kinase (BTK). The invention also contemplates the use of the compounds for treating conditions treatable by the inhibition of Bruton's tyrosine kinase, for example cancer, lymphoma, leukemia and immunological diseases.
Inventor(s):	Guisot Nicolas
Assignee:	Loxo Oncology Inc.
Application Number:	US16113661
Patent Claim Types: see list of patent claims

United States Patent 10,464,905: A Comprehensive Analysis

Overview of the Patent

United States Patent 10,464,905, titled "Compounds useful as kinase inhibitors," is a significant patent in the field of pharmaceuticals, particularly focusing on inhibitors of Bruton's tyrosine kinase (BTK). Here is a detailed analysis of its scope, claims, and the broader patent landscape.

Inventors and Assignees

This patent was invented by Nicolas Guisot and assigned to Loxo Oncology, Inc., a company known for its innovative approaches in cancer treatment[5].

Issuance and Expiration Dates

The patent was issued on November 5, 2019, and is set to expire on December 16, 2036. This expiration date aligns with the typical 20-year patent term from the date of filing, although the exact filing date is not specified in the provided sources[5].

Scope of the Patent

Mechanism of Action

The patent revolves around novel compounds that act as tyrosine kinase inhibitors, specifically targeting Bruton's tyrosine kinase (BTK). BTK is a key enzyme in the B-cell receptor signaling pathway, and its inhibition is crucial for treating various B-cell-related cancers and immunological diseases[1][5].

Indicated Conditions

The compounds described in this patent are intended for treating conditions that are responsive to BTK inhibition. These include:

• Cancer
• Lymphoma
• Leukemia
• Immunological diseases

These conditions are addressed by inhibiting the BTK pathway, which is often dysregulated in these diseases[5].

Claims of the Patent

Compound Structure

The patent claims cover a range of chemical compounds that are designed to inhibit BTK. These compounds are characterized by specific structural features, including various substitutions and modifications that enhance their selectivity and potency as BTK inhibitors[5].

Use in Treatment

The claims extend to the use of these compounds in the treatment of BTK-related diseases. This includes methods of administration, dosages, and combinations with other therapeutic agents to enhance efficacy or reduce side effects[5].

Pharmaceutical Compositions

The patent also covers pharmaceutical compositions containing these BTK inhibitors. This includes formulations such as tablets, capsules, and injectables, as well as methods for their preparation and use[5].

Patent Landscape

Related Patents

Several related patents have been issued to Loxo Oncology, Inc., all focusing on BTK inhibitors. These include:

• Patent 10,342,780
• Patent 10,695,323
• Patent 10,918,622
• Patent 12,109,193

All these patents share similar expiration dates, indicating a coordinated strategy to protect the intellectual property related to BTK inhibitors[5].

Patent Expiration Dates

The expiration dates for these related patents are crucial for understanding the competitive landscape. All the mentioned patents expire on December 16, 2036, except for Patent 12,109,193, which expires on September 14, 2041. This uniform expiration date suggests a strategic approach to maintain exclusive rights over BTK inhibitors for an extended period[5].

Intellectual Property Protection

The patent landscape is further complicated by the interplay between patent protection and FDA exclusivity. While patents provide exclusive rights to the chemical formulation, FDA exclusivity grants sole marketing rights for a specified period. This dual protection ensures that Loxo Oncology, Inc. maintains a strong market position for its BTK inhibitors[5].

Clinical and Therapeutic Implications

Pirtobrutinib as an Example

One of the compounds covered under this patent is pirtobrutinib, a non-covalent BTK inhibitor. Pirtobrutinib has shown significant selectivity for BTK over other kinases, making it a promising therapeutic agent for treating B-cell cancers and other BTK-related diseases[1].

Clinical Trials

The compounds described in this patent are undergoing various stages of clinical trials. As of the latest data, there are multiple Phase 1, Phase 2, and Phase 3 trials ongoing, indicating a robust clinical development pipeline for these BTK inhibitors[1].

Economic and Market Impact

Market Dominance

The exclusive rights granted by this patent and related patents ensure that Loxo Oncology, Inc. maintains a dominant position in the market for BTK inhibitors. This dominance is crucial for the company's revenue and market share, especially given the growing demand for targeted cancer therapies.

Future Developments

As the patent landscape evolves, it is essential for companies like Loxo Oncology, Inc. to continuously monitor and adjust their patent strategies. This includes filing new patents, managing existing ones, and ensuring that there are no gaps in their intellectual property coverage[3].

Key Takeaways

• BTK Inhibition: The patent focuses on compounds that inhibit Bruton's tyrosine kinase, a key enzyme in B-cell signaling.
• Therapeutic Applications: These compounds are used to treat B-cell cancers, lymphoma, leukemia, and immunological diseases.
• Patent Expiration: The patent expires on December 16, 2036, aligning with related patents.
• Intellectual Property: The patent is part of a broader strategy to protect BTK inhibitors through multiple patents and FDA exclusivity.
• Clinical Development: The compounds are in various stages of clinical trials, indicating a strong pipeline for future therapeutic agents.

FAQs

What is the primary mechanism of action of the compounds described in Patent 10,464,905?

The compounds act as inhibitors of Bruton's tyrosine kinase (BTK), a key enzyme in the B-cell receptor signaling pathway.

What conditions are treated by the compounds described in this patent?

The compounds are intended for treating cancer, lymphoma, leukemia, and immunological diseases.

Who is the assignee of Patent 10,464,905?

The assignee is Loxo Oncology, Inc.

When does Patent 10,464,905 expire?

The patent expires on December 16, 2036.

What is the significance of pirtobrutinib in the context of this patent?

Pirtobrutinib is a non-covalent BTK inhibitor with high selectivity for BTK, making it a promising therapeutic agent covered under this patent.

Sources

1. DrugBank: Pirtobrutinib: Uses, Interactions, Mechanism of Action.
2. Google Patents: US10695323B2 - Compounds useful as kinase inhibitors.
3. SLWIP: Patent Analytics | Intellectual Property Law.
4. Google Patents: WO2015048662A2 - Substituted nicotinimide inhibitors of btk and their preparation and use in the treatment of cancer, inflammation and autoimmune disease.
5. Drugs.com: Generic Jaypirca Availability.

Drugs Protected by US Patent 10,464,905

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-001	Jan 27, 2023		RX	Yes	No						TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA (MCL) AFTER AT LEAST TWO LINES OF SYSTEMIC THERAPY, INCLUDING A BTK INHIBITOR
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-001	Jan 27, 2023		RX	Yes	No						ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL) WHO HAVE RECEIVED AT LEAST TWO PRIOR LINES OF THERAPY, INCLUDING A BTK INHIBITOR AND A BCL-2 INHIBITOR
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes						TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA (MCL) AFTER AT LEAST TWO LINES OF SYSTEMIC THERAPY, INCLUDING A BTK INHIBITOR
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes						ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL) WHO HAVE RECEIVED AT LEAST TWO PRIOR LINES OF THERAPY, INCLUDING A BTK INHIBITOR AND A BCL-2 INHIBITOR

International Family Members for US Patent 10,464,905

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3390395		CA 2024 00006	Denmark
European Patent Office	3390395		301262	Netherlands
European Patent Office	3390395		LUC00330	Luxembourg
European Patent Office	3390395		PA2024506	Lithuania
European Patent Office	3390395		CR 2024 00006	Denmark
European Patent Office	3390395		C03390395/01	Switzerland
European Patent Office	3390395		2024C/506	Belgium