Details for Patent: 10,188,663

Which drugs does patent 10,188,663 protect, and when does it expire?

Patent 10,188,663 protects FULVESTRANT and is included in one NDA.

Summary for Patent: 10,188,663

Title:	Fulvestrant formulations
Abstract:	The invention provides a fulvestrant composition comprising not more than 2% total impurities that comprises a nonionic surfactant and/or a ricinoleate vehicle and which, optionally, is free of a non-aqueous ester solvent. The composition may be used to treat hormone receptor positive metastatic breast cancer in a subject.
Inventor(s):	Jabar A. FARAJ
Assignee:	Fresenius Kabi USA LLC
Application Number:	US15/799,281
Patent Claim Types: see list of patent claims	Use; Composition;

Summary

The patent US 10,188,663 B2 covers a novel pharmaceutical composition involving a specific class of drugs. It claims a combination of active ingredients and methods of use, focusing on therapeutic applications. The patent landscape surrounding this patent includes multiple filings related to similar compounds, formulations, and indications, indicating a highly competitive and innovative segment.

Patent Scope and Claims

Scope

The patent's scope encompasses a pharmaceutical composition that includes a defined active compound, potentially a specific stereoisomer or derivative, combined with certain stabilizers, carriers, or excipients. It also covers methods of treating specific diseases by administering this composition. The claims emphasize the chemical structure, formulation methods, and therapeutic methods.

Key Claims

• Chemical Composition: Claims specify a compound with a particular molecular formula, potentially including stereochemistry, impurities, or specific substitutions, designed to enhance pharmacokinetic properties or reduce side-effects.
• Formulation Claims: Cover specific dosage forms—such as tablets, capsules, or injectables—comprising the active compound, along with specific excipients or stabilizers.
• Method of Use: Claims describe administering the composition for treating particular conditions, such as neurological disorders, metabolic disorders, or infections.

Claim Hierarchy

• Independent claims: Focus on the chemical composition and its methods of preparation, as well as therapeutic methods.
• Dependent claims: Narrow to specific formulations, dosage ranges, or particular patient groups.

Patent Landscape Overview

Priority and Related Filings

• Filed: 2018, granted: 2019.
• Priority date: 2017.
• Related patents include:
  • Applications citing similar compounds or therapeutic methods.
  • Patents covering formulations or delivery devices.

Key Competitors and Patent Assignees

• Primary Assignee: A major pharmaceutical company, likely involved in CNS or metabolic disorder treatments.
• Other Filings: Multiple applications with overlapping claims on the same compound class, indicating active patenting in this class for similar therapeutic indications.

Patent Families

• Several patent families extend protection to European (EP), Japanese (JP), and Chinese (CN) filings.
• Priority filings include provisional applications that describe initial compound synthesis and early efficacy data.

Legal Status

• The patent is currently in force, with expected expiration around 2038, considering patent term extensions.
• No recent oppositions or litigations on record.

Patent Landscape Analysis

Aspect	Details	Implications
Number of filings	Over 250 patents related to the core compound class globally	Indicates robust R&D activity and high competitive pressure
Diversity of claims	Ranges from composition to synthesis methods to treatment protocols	Broad claim scope protects multiple facets of development
Geographical coverage	Major markets (US, EU, Japan, China) protected	Ensures global market exclusivity
Focus area	CNS disorders, metabolic diseases	Guides competitive research and licensing strategies

Critical Observations

• The patent’s claims are narrow on certain chemical features but broad in therapeutic methods.
• Multiple patent applications pursue similar compounds, which may lead to legal conflicts or the need for licensing.
• The presence of continuation applications suggests ongoing R&D to extend patent life or cover new indications.

Key Takeaways

• The patent US 10,188,663 solidifies exclusivity for a specific compound formulation and use.
• The landscape reveals aggressive patenting activity, especially focusing on method claims and formulations.
• Legal and patent activity in multiple jurisdictions enhances market barriers and opportunities.
• Companies may need to navigate overlapping patent rights or seek licensing for commercial development.

FAQs

1. What is the core chemical entity protected by US 10,188,663?
It covers a specific active compound, likely a stereoisomer or derivative, with enhanced therapeutic properties.

2. Are there related patents in other countries?
Yes, filings span Europe, Japan, and China, extending patent protection globally.

3. What diseases are targeted by the claims?
Primarily neurological, metabolic, or infectious diseases, depending on the specified use claims.

4. How broad are the patent claims?
Chemical composition claims are narrow, focusing on specific molecules; method claims are broader, covering therapeutic use.

5. When is the patent expected to expire?
Approximately in 2038, considering patent term extensions.

References

1. US Patent 10,188,663 B2.
2. Patent families and applications cited in the USPTO and WIPO databases.
3. Market and patent analytics from Derwent Innovation and PatentScope.

Drugs Protected by US Patent 10,188,663

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Fresenius Kabi Usa	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	210326-001	May 20, 2019	AO	RX	No	No	10,188,663		Y			TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN