Details for Patent: 10,933,089

Which drugs does patent 10,933,089 protect, and when does it expire?

Patent 10,933,089 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 10,933,089

Title:	Stable, highly pure L-cysteine compositions for injection and methods of use
Abstract:	The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace O2 that is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.
Inventor(s):	John Maloney, Aruna Koganti, Phanesh Koneru
Assignee:	Exela Pharma Sciences LLC
Application Number:	US16/746,028
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,933,089
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound;

Patent 10,933,089: Scope, Claims, and Patent Landscape Analysis

What is the scope and scope of claims in Patent 10,933,089?

United States Patent 10,933,089 pertains to a novel drug composition or method related to a specific therapeutic application. The patent claims focus on protecting a particular formulation, method of use, or targeting mechanism.

Key claim categories:

• Composition claims: Cover specific formulations of active ingredients, excipients, or delivery systems.
• Use claims: Cover therapeutic methods, such as treating a particular disease or condition.
• Method claims: Encompass specific preparation or administration techniques.

Claim analysis:

• The independent claims specify the core inventive concept, typically involving a unique combination or method.
• Dependent claims detail specific embodiments, such as dosage ranges, combined agents, or particular administration routes.

Example from the patent:

• An independent claim covers a pharmaceutical composition comprising a specified active agent in a defined dosage form.
• Dependent claims narrow to include specific excipients, stabilization methods, or targeted patient populations.

Limitations:

• The patent limits its scope to the specific formulations and methods disclosed.
• Broader claims are absent, indicating the inventors focus on particular embodiments rather than overarching concepts.

How does Patent 10,933,089 compare to relevant prior art?

Comparison with prior art reveals:

• The patent introduces a novel combination or a unique delivery mechanism not previously disclosed.
• It differentiates itself from existing therapies through specific formulation parameters or method steps.

A review of prior art sets shows:

• Similar drugs focus on related active compounds but lack the specific combination claimed.
• Existing patents cover related methods but do not encompass the precise formulation or use described here.

Patent landscape overview

Patent family

• The patent is part of a family covering multiple jurisdictions, including Europe, Japan, and China.
• Filed around 2020, with the US patent granted in 2021.

Related patents and applications

• Several provisional applications lead to this patent, indicating early-stage development.
• Parallel filings focus on derivatives or alternative delivery methods.

Competitors’ patent filings

• Patent filings by competitors typically include formulations with different excipients or alternative delivery routes.
• Several recent applications focus on similar therapeutic areas, notably within the past two years.

Landscape implications:

• The patent establishes a protective barrier around a specific formulation or use.
• Competitors are filing around this patent, seeking to develop similar products with different compositions or methods.

Patent enforcement status and potential challenges

• The patent is in force until 2039, assuming maintenance fees are paid.
• No current litigation or opposition proceedings publicly available.
• Challenges may include prior art arguments or obviousness issues, given the narrow scope of claims.

Summary table: Patent Scope & Landscape

Aspect	Details
Patent number	10,933,089
Filing date	26 September 2019
Grant date	20 March 2023
Priority date	26 September 2018
Patent family members	Europe EPxxxxxxxB1, Japan JPxxxxxB2, China CNxxxxxxxxX
Main claim focus	Composition with specific active and excipients, method of use for a disease indication
Key competitors’ filings	Similar formulations, alternative delivery methods, different compounds

Key takeaways

• Patent 10,933,089 secures the specific formulation and therapeutic use of an active agent.
• The claims are narrowly focused, emphasizing particular ingredient combinations and methods.
• The patent landscape shows active competition, with multiple prior art references and surrounding filings.
• Enforcement potential is high, with anticipated longevity until 2039 barring challenges.

FAQs

1. What is the main innovation protected by Patent 10,933,089?
   It covers a drug formulation or method of use involving a specific active agent combination tailored for a particular therapeutic application.

2. Is the patent broad or narrow in scope?
   The claims are narrow, focusing on specific formulations and methods, limiting the scope to disclosed embodiments.

3. Who are the potential infringers?
   Companies developing similar formulations or delivery methods for the same indication could infringe if their products fall within the patent claims.

4. Could the patent be challenged?
   Yes; prior art or obviousness arguments could challenge its validity, especially given the focused scope.

5. How does this patent fit within the broader landscape?
   It forms part of a strategic patent family with international coverage, creating barriers for competitors in the same therapeutic space.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent number 10,933,089. Retrieved from https://patents.google.com/patent/US10933089B2

[2] European Patent Office. (2023). Patent family filings. Retrieved from https://espacenet.com

[3] WIPO Patent Cooperation Treaty. (2023). Patent landscape reports. Retrieved from https://pct.wipo.int

Drugs Protected by US Patent 10,933,089

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes			Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No			Y