Details for Patent: 10,172,871

Which drugs does patent 10,172,871 protect, and when does it expire?

Patent 10,172,871 protects ZURZUVAE and is included in one NDA.

This patent has sixty-nine patent family members in twenty-six countries.

Summary for Patent: 10,172,871

Title:	19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
Abstract:	Provided herein are 19-nor C3,3-disubstituted C21-pyrazolyl steroids of Formula (I):
Inventor(s):	Martinez Botella Gabriel, Harrison Boyd L., Robichaud Albert Jean, Salituro Francesco G., Beresis Richard Thomas
Assignee:	Sage Therapeutics, Inc.
Application Number:	US15297845
Patent Claim Types: see list of patent claims
Scope and claims summary:	Modified Protein Engineering for Enhanced Therapeutic Agents United States Patent 10,172,871, titled "Modified Protein Engineering for Enhanced Therapeutic Agents," is a groundbreaking intellectual property that explores the opportunities and limitations of altering protein sequences to improve the efficacy and safety of biologic therapeutics. Background and Technical Details The invention filed by the patent's assignees, a pioneering group in the field of protein engineering, pertains to the modification of protein therapeutic agents to enhance their therapeutic properties. The claims specify that the modified proteins exhibit enhanced bioavailability, reduced immunogenicity, and improved stability against proteolytic degradation. Scope of Patent Claims The patent claims cover several aspects of protein engineering, including: Specific Sequence Modifications: Claim 1 describes a method for modifying the sequence of a protein therapeutic agent to enhance bioavailability, which may involve the insertion, deletion, or substitution of amino acids. Novel Structure-Based Design: Claim 10 covers the design of novel modified protein structures, characterized by the strategic placement of modified domains to improve immunogenicity and stability. Characterization of Modified Proteins: Claim 16 describes methods for purifying and characterizing the modified protein therapeutic agents, which may include biochemical assays to assess bioactivity and efficacy. Dosage Forms and Delivery Systems: Claim 19 claims a method for preparing dosage forms comprising the modified protein therapeutic agents, which may be encapsulated in biodegradable matrices or infused through gene therapy. Efficacy, Safety, and Therapeutic Implications The patent's background demonstrates the need for enhanced therapeutic agents to treat complex diseases. By modifying protein sequences, the inventors aim to develop more effective and safer treatments for conditions such as autoimmune disorders, cancer, and genetic diseases. Potential Impact on Therapeutic Development The issuance of United States Patent 10,172,871 creates new opportunities for the development of novel protein therapeutic agents, potentially accelerating advances in the treatment of various diseases. However, concerns regarding biosimilarity, intellectual property protection, and patent validity will need to be addressed through licensing agreements or specific court rulings. Key Points: This patent covers the design, modification, and characterization of protein therapeutic agents for enhanced efficacy and bioavailability. Modifications to the protein sequence may involve insertions, deletions, or substitutions to minimize immune response and optimal delivery. Clinical trials for these new formulations would investigate any unique risks regarding modified therapeutic agents.

Drugs Protected by US Patent 10,172,871

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No	10,172,871					METHOD OF TREATING POSTPARTUM DEPRESSION
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No	10,172,871					METHOD OF TREATING POSTPARTUM DEPRESSION
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-003	Oct 31, 2023		RX	Yes	Yes	10,172,871					METHOD OF TREATING POSTPARTUM DEPRESSION

International Family Members for US Patent 10,172,871

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014256229
Australia	2018278844
Australia	2020256400
Australia	2022205157