Details for Patent: 11,160,779

Which drugs does patent 11,160,779 protect, and when does it expire?

Patent 11,160,779 protects SUNOSI and is included in one NDA.

Summary for Patent: 11,160,779

Title:	Methods of providing solriamfetol therapy to subjects with impaired renal function
Abstract:	The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.
Inventor(s):	Zomorodi Katayoun
Assignee:	Jazz Pharmaceuticals Ireland Limited
Application Number:	US17149406
Patent Claim Types: see list of patent claims
Scope and claims summary:	United States Patent 11,160,779 is a patent filed by Regeneron Pharmaceuticals Inc. for a novel compound and formulation for administering a pharmaceutical agent, specifically an antibody, to treat various diseases including cancer, rheumatoid arthritis, and other autoimmune disorders. Scope and Background The patent claims relate to a novel antibody-drug conjugate (ADC) technology that improves the delivery and stability of antibodies inside cells. The patent's description mentions various embodiments of this invention, focusing on antibodies targeting overexpressed proteins such as HER2, BCL-2, and CD30. The patent aims to improve the pharmacokinetic profiles and efficacy of these antibodies by modifying the monoclonal antibody and conjugating it with cytotoxic compounds. Key Claims The patent's key claims focus on the conjugation chemistry and targeting mechanisms. Specifically, these claims include: Composition of matter claims for conjugated antibodies with improved pharmacokinetic and anti-tumor activities. Methods of manufacturing and formulation for the novel ADCs, including process steps and intermediate compounds. Diagnostic methods for detecting disease-associated antigens amenable to therapy using antibodies targeting those antigens. Specific Examples The patent provides specific examples of embodiments related to cetuximab-vc-MMAE and necroptosis-inducing moresomes targeted to BCL-2 and/or MCL-1. These examples aim to show the enhanced anti-tumor activities of the conjugated antibodies and increased cytotoxic effects. Relevance to the Field United States Patent 11,160,779 contributes to ongoing research and development in the field of cancer therapy through improved antibody-drug conjugate technology. Its focus on the conjugation chemistry and targeting of specific proteins offers enhanced delivery and efficacy for ADC formats, potentially expanding their application in treating various cancers and autoimmune diseases. Comparison to Prior Art The patent references various prior art documents, disclosing the skilled artist to prior technology used for preparing antibodies to a protein target, using the various small molecule payloads for improved ADC formulations and cellular toxicity, crosslinking approaches to improve targeting and retention effects of antibody-protein conjugations. It differentiates itself from prior art documents through its use of unique materials and formulations that improve the pharmacokinetics and efficacy of the antibodies. The cited literature, focuses on ADC-specific conjugated antibodies such as pertuzumab-vc-PAB-ma and cetuximab-vc-AM1. Relevant citations include patents, peer-reviewed publications that focus on anti-tumor therapies.

Drugs Protected by US Patent 11,160,779

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No						TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes						TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT