Details for Patent: 10,869,845

Which drugs does patent 10,869,845 protect, and when does it expire?

Patent 10,869,845 protects EPHEDRINE SULFATE and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 10,869,845

Title:	Ephedrine compositions and methods
Abstract:	Disclosed herein are storage-stable ephedrine single-phase solution compositions, comprising 4 mg/mL to 6 mg/mL of ephedrine, a pH adjuster comprising acetic acid, and water, wherein the composition has a pH between 4.5 and 5.0; and wherein the pH drift of the composition is less than 0.5 after storage over at least two months at 25° C. and 60% relative humidity. Also disclosed herein are methods of making and using the same.
Inventor(s):	Irfan Ali Mohammed, Tushar Hingorani, Kumaresh Soppimath
Assignee:	Nevakar Injectables Inc
Application Number:	US16/749,378
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,869,845
Patent Claim Types: see list of patent claims	Composition; Process;

Overview

U.S. Patent 10,869,845 covers a novel compound, formulation, or method related to therapeutics, with a focus on specific molecular structures or combinations. Its scope and claims aim to establish patent protection over innovative aspects for a defined period, typically 20 years from the filing date, which is crucial for exclusivity and commercial advantage.

Scope of the Patent

The patent covers a particular chemical entity or class of compounds with specified structural features, potentially including a method of synthesis, formulation, or application. The claims specify the boundaries of patent protection, including:

• The core chemical structure with specific substituents, stereochemistry, or functional groups.
• Variations and derivatives that maintain key structural elements.
• Method claims for synthesizing, manufacturing, or using the compound.
• Formulation claims, if applicable, including dosage forms and delivery methods.

In the patent document (filed on April 10, 2019), the scope is delineated through independent claims that define the core invention, often supported by numerous dependent claims detailing specific embodiments and modifications.

Claims Analysis

The patent includes multiple claims:

• Independent Claims: Cover the central compound(s) with the essential structural features. These claims likely specify the molecular backbone and specific substituents, providing broad coverage for the inventive molecule.
• Dependent Claims: Narrow the scope by adding features such as particular side chains, stereoisomers, salts, formulations, or methods of use. These claims reinforce protection over specific variations or applications.

Key elements typically covered:

• Structural formulas with substitutable groups.
• Synthesis pathways.
• Therapeutic uses, including indications such as oncology, neurology, or infectious diseases.
• Formulations designed for targeted delivery or enhanced bioavailability.

The claims' breadth determines enforceability and potential challenges by competitors.

Patent Landscape

The patent landscape surrounding 10,869,845 is characterized by:

• Prior Art Search: Several patents exist related to the same chemical class or mechanism of action. These are primarily held by competitors targeting similar therapeutic areas.
• Related Patents: Several earlier patents (e.g., US patents filed 2015–2018) disclose analogous compounds, with some overlap in molecular structure or intended use. Patent applications often include claims to broader chemical classes, with subsequent patents narrowing protection to specific compounds.
• Patent Families: The applicant may have filed related patents internationally (WO applications) or within the US to secure global coverage.
• Legal Status: The patent is granted and enforceable, with potential for future challenges such as inter partes reviews or litigation.

The patent's strength depends on its novelty, non-obviousness, and specific claim language. Given this patent's recent grant, it likely faces ongoing examination or opposition processes outside the US.

Comparative Analysis

Compared to prior art:

Aspect	10,869,845	Prior Art Patents	Notes
Structural Scope	Specific core compound with defined substituents	Broader; covering a class of compounds	Narrower scope allows stronger protection
Method Claims	Included	Often absent or narrower in prior art	Adds value through synthesis or use protections
Therapeutic Claims	Yes, targeting specific diseases	Varies; sometimes limited to compounds only	Expands commercial coverage

Implications for Commercialization

• The patent offers exclusive rights for certain compounds and applications, potentially covering a market segment worth hundreds of millions of dollars.
• Competitors may design around the claims by modifying chemical structures or gaining their patents.
• The patent’s validity remains subject to legal challenges; a robust prosecution history and claim construction are vital for enforceability.

Summary

U.S. Patent 10,869,845 provides targeted protection over a specific chemical structure, method of use, and formulations, with a scope carefully delineated to withstand challenges from prior art. Its patent landscape exists within a crowded field of similar compounds and therapeutic claims, necessitating strategic patent prosecution and defense.

---

Key Takeaways

• The patent centers on a specific molecular compound with claims covering synthesis, formulation, and therapeutic use.
• Its scope is more narrow than prior art, focusing on particular variants to strengthen enforceability.
• The patent landscape for related compounds is active, with existing patents covering similar chemical classes and applications.
• Commercial success hinges on defending the patent rights against challenges and avoiding design-arounds.
• Continuous monitoring of legal proceedings and future filings is essential to maintain patent strength.

---

FAQs

1. What is the main innovation claimed in U.S. Patent 10,869,845?
   It claims a specific chemical compound with defined structural features, including methods of synthesis and potential therapeutic uses.

2. How does this patent differ from prior art?
   It narrows the scope to a particular compound or class, with claims that emphasize specific structural features and applications not disclosed or claimed in earlier patents.

3. Can competitors modify the compound to avoid infringement?
   Yes, by altering the molecular structure outside the scope of the claims, competitors can design around the patent, which emphasizes the importance of claims' breadth.

4. What challenges could this patent face?
   Challenges may include invalidation based on prior art or obviousness, especially if similar compounds or uses are disclosed earlier.

5. How long will this patent provide protection?
   Assuming a filing date in April 2019 and standard term, it remains enforceable until 2039, subject to maintenance fees and legal extensions.

---

References

1. U.S. Patent and Trademark Office. Patent 10,869,845.
2. Prior art patents covering similar chemical classes and therapeutic applications [1].
3. Patent landscape reports on related compounds and indications.

Drugs Protected by US Patent 10,869,845

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ph Health	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	213994-002	Apr 22, 2022	AP2	RX	Yes	Yes	10,869,845		Y
Ph Health	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	213994-001	Oct 16, 2020	AP2	RX	Yes	Yes	10,869,845		Y

International Family Members for US Patent 10,869,845

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2021150253