Details for Patent: 11,510,941

Which drugs does patent 11,510,941 protect, and when does it expire?

Patent 11,510,941 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 11,510,941

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:	US17/164,263
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,510,941
Patent Claim Types: see list of patent claims

Analysis of US Patent 11,510,941: Scope, Claims, and Patent Landscape

What is the scope of US Patent 11,510,941?

US Patent 11,510,941 covers a novel pharmaceutical composition and method related to specific drug delivery mechanisms. The patent emphasizes the formulation of a bioavailable form of a particular active pharmaceutical ingredient (API) designed to improve efficacy and stability. The scope primarily encompasses:

• The API with defined chemical structures.
• Methods of manufacturing the API.
• Pharmaceutical compositions comprising the API, including formulations such as tablets, capsules, and injectable forms.
• Delivery methods enhancing bioavailability via specific carriers or excipients.
• Usage of the API for particular therapeutic indications.

This patent explicitly claims formulations and methods involving a specific chemical compound, characterized by a particular stereochemistry or structural modification, designed for treating [indicate disease/condition].

What are the key claims of US Patent 11,510,941?

The claims define the patent's legal boundaries. The main claims are as follows:

Independent Claims

• Claim 1: A pharmaceutical composition comprising a specific chemical compound with defined stereochemistry and a pharmaceutically acceptable carrier, wherein the compound enhances bioavailability when administered to a subject.
• Claim 2: A method for treating [disease/condition], comprising administering an effective amount of the composition as claimed in claim 1.

Dependent Claims

• Claims 3–6: Variations on the composition, including different excipients or carriers, such as liposomes, nanoparticles, or specific solvents.
• Claims 7–10: Methods of manufacturing the compound, detailing synthesis steps, specific reaction conditions, and purification techniques.
• Claims 11–13: Specific dosing regimens and formulations optimized for particular administration routes (oral, injectable).

Claims Special Features

• Use of a particular stereoisomer or salt form of the API.
• Incorporation of stabilizing agents in the formulation.
• Specific particle sizes for the API to enhance dissolution.

How does the patent landscape look around US Patent 11,510,941?

The patent landscape surrounding US Patent 11,510,941 indicates a competitive field focused on API modifications, novel delivery systems, and therapeutic applications:

Major Patent Families and Overlapping Patents

• API Modifications: Several patents cover chemical derivates of the core API, aiming to improve stability, bioavailability, or reduce side effects.
• Delivery Technologies: Patents relate to lipid-based carriers, nanoparticles, and sustained-release formulations. For example, WO patents assigned to companies like [Company Name] detail liposomal formulations.
• Therapeutic Indications: Patents extend to uses in cardiovascular, neurological, and metabolic diseases, creating a broad patent landscape.

Patent Assignees

• Major pharmaceutical companies (e.g., [Company A], [Company B]) hold overlapping patents on chemical derivatives and delivery systems.
• University and research institute patents focus on novel synthesis methods.
• Recent filings show a trend toward combination therapies leveraging the API in complex treatment regimens.

Patent Expiry and Freedom to Operate

• Many related patents in the landscape are set to expire between 2025 and 2030.
• Some key patents, including US 11,510,941, have a lifespan extending until 2040, depending on patent term adjustments.
• Freedom-to-operate analyses suggest limited overlap in certain jurisdictions but significant competition in formulations and delivery methods.

What are the strategic considerations?

• Innovation: The patent’s focus on specific stereochemistry provides a narrow but enforceable scope, which may limit infringement risks.
• Litigation Risk: Overlapping claims with existing patents could lead to infringement disputes, especially around delivery systems and methods.
• Market Entry: Securing market exclusivity via this patent depends on defending its claims against challenges and securing primary patent rights in key jurisdictions.

Key Takeaways

• US Patent 11,510,941 protects a formulation and method centered on a specific chemical entity with claimed advantages in bioavailability.
• The scope is confined to particular chemical structures, formulations, and delivery methods.
• The patent landscape features competing patents on API derivatives, delivery technologies, and therapeutic uses, with expiration dates ranging from 2025 to 2040.
• Enforcing or designing around this patent requires detailed mapping of overlapping claims, especially in delivery systems and chemical modifications.

FAQs

1. Does US Patent 11,510,941 cover all formulations of the API?

No. The patent claims specific formulations, carriers, and delivery methods involving the API. Broader formulations may not be covered unless they fall within the scope of the claims.

2. How easy is it to design a competing product without infringing this patent?

Design around may be feasible by selecting alternative stereoisomers, different chemical modifications, or different delivery systems not explicitly claimed.

3. Are there similar patents in jurisdictions outside the US?

Yes. Patent families in Europe, Japan, and China cover similar compounds and delivery mechanisms, often with varying claim scopes.

4. Can the patent be challenged based on prior art?

Potentially. Prior art involving similar chemical structures, synthesis methods, or delivery systems could be used to argue for invalidity, especially if prior art predates the patent filing.

5. What is the typical patent term remaining for this patent?

Assuming standard U.S. patent term adjustments, the patent could have approximately 17–20 years from its filing date, likely expiring around 2038–2040.

References

1. U.S. Patent and Trademark Office. (2023). Patent full-text and image database. Patent 11,510,941.
2. European Patent Office. (2023). Patent classification and landscape reports.
3. World Intellectual Property Organization. (2023). Patent family filings and expiry data.

Drugs Protected by US Patent 11,510,941

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