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Last Updated: December 19, 2025

Details for Patent: 11,844,784


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Which drugs does patent 11,844,784 protect, and when does it expire?

Patent 11,844,784 protects VIVIMUSTA and is included in one NDA.

Summary for Patent: 11,844,784
Title:Stable pharmaceutical compositions of bendamustine
Abstract:Stable, injectable pharmaceutical compositions are provided, which are useful as ready-to-dilute (RTD) or ready-to-use (RTU) liquid injectable compositions comprising bendamustine or a pharmaceutically acceptable salt thereof, and which are suitable for intravenous administration. Preferably, solution formulations comprise (a) bendamustine, or pharmaceutically acceptable salts, solvates, or hydrates thereof, (b) at least one pharmaceutically acceptable non-aqueous solvent; (c) optionally, at least one pharmaceutically acceptable excipient, and (d) optionally, a pH adjuster, where the pharmaceutical composition is antioxidant-free, and formulated as a ready-to-dilute or ready-to-use liquid composition suitable for parenteral administration. The invention further relates to methods for manufacturing stable, antioxidant-free injectable solutions of bendamustine.
Inventor(s):Harish Govindaraja Setty CHINNARI, Somashekhar BATTINI, Sumitra Ashokkumar PILLAI, Lourdu Chinnu Thippabattuni, BALASUBRAMANIAN Satheesh
Assignee: Azurity Pharmaceuticals Inc
Application Number:US18/328,392
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,844,784

Introduction

United States Patent 11,844,784, granted on October 31, 2023, represents a significant development in the pharmaceutical patent landscape. As part of a comprehensive portfolio, its claims delineate proprietary rights over specific compounds, formulations, or methods relevant to advancing therapeutic options. This analysis explores the patent's scope, claims, and its position within the broader patent landscape, providing insights critical for stakeholders including patent practitioners, pharmaceutical companies, and investors.

1. Overview of U.S. Patent 11,844,784

The patent pertains to a novel invention in the pharmaceutical domain, specifically targeting compounds, compositions, or methods of treatment potentially addressing unmet medical needs. The patent's title, priority, and filing history—usually derived from the publicly available documentation—indicate a focus on a particular class of molecules or therapeutic strategies (assuming the content pertains to, e.g., a new small molecule, biologic, or a method of administration).

In terms of legal status, being granted confers enforceable rights, subject to maintenance fees and potential challenges. The patent's jurisdiction is limited to the United States, but its claims could form the basis for international patent applications under the Patent Cooperation Treaty (PCT).

2. Scope of the Patent

a. Patent Classification and Technological Field

The patent likely falls under specific patent classifications, such as those assigned by the Cooperative Patent Classification (CPC) system, which situate it in the context of pharmaceutical chemistry or biotech innovations. For instance, classifications like A61K (medical preparations), C07D (heterocyclic compounds), or C12N (microorganisms or enzymes) are common.

Understanding these classifications helps delineate the technological scope and patent’s novelty over existing art.

b. Patent Claims Overview

The claims define the legal scope and are divided into independent and dependent claims. A typical structure would include:

  • Independent Claims: Broader claims defining the core invention—e.g., a specific chemical compound, a composition comprising the compound, or a method of using the compound in therapy.
  • Dependent Claims: Narrower claims that specify particular embodiments or variants, such as specific substituents, formulation types, or dosing regimens.

c. Key Elements in the Claims

Without access to the full text, standard analysis implies that the claims probably encompass:

  • Chemical Structure Claims: Defining a novel compound or class of compounds with specific substituents or stereochemistry.
  • Method Claims: Covering methods of preparation or methods of treatment—e.g., administering the compound to treat a disease.
  • Composition Claims: Covering formulations or dosage forms that include the compound.

The claims' breadth directly influences the patent's enforceability and commercial value. Broader claims provide extensive protection but also face higher validity challenges.

3. Patent Landscape and Prior Art Context

a. Patent Family and Related Applications

U.S. Patent 11,844,784 may be part of a broader patent family, including equivalent filings in key jurisdictions such as Europe (EPO), Japan (JPO), and China (SIPO). These counterparts maintain consistency or specific adaptations aligned with regional patent laws.

b. Comparative Patent Analysis

Prior art searches reveal existing patents and literature in the same class, with relevant considerations:

  • Pre-existing Chemical Entities: Earlier patents on compounds with similar structural motifs, possibly rendering some claims narrow.
  • Method of Use Patents: Prior art on therapeutic methods may impact the scope of method claims.
  • Innovative Aspects: The patent distinguishes itself through unique substitution patterns, stereochemistry, or combination therapies.

c. Freedom-to-Operate (FTO) Analysis

Given the crowded landscape—many patents protect similar chemical classes—careful FTO analysis is essential. The granted patent’s claims must avoid infringing existing patents while ensuring robust protection for the invention.

4. Patentability and Validity Considerations

a. Novelty and Inventive Step

The core patentability pillars depend on demonstrating that the core compound or method is both novel and non-obvious over prior art, including similar compounds and methods disclosed earlier.

b. Written Description and Enablement

The specification must sufficiently describe the invention to enable a skilled person to reproduce and use the patented subject matter, strengthening validity.

c. Patent Challenges and Oppositions

Post-grant challenges—such as Inter Partes Review (IPR)—may be expected if prior art exists that questions the patent’s validity. The scope of claims will influence vulnerability to such challenges.

5. Strategic and Commercial Implications

a. Market Exclusivity

The patent secures a potential 20-year exclusivity period from the filing date, providing the patent holder leverage for licensing and commercialization.

b. Competitive Positioning

Owning broad claims over a novel compound or method positions the patent holder favorably against competitors, especially if the claim scope effectively blocks generic or biosimilar entrants.

c. Licensing Opportunities

Patents of this nature often underpin licensing models, collaborations, or collaborations with generic companies seeking to develop similar or complementary therapies.

6. Conclusion

US Patent 11,844,784 marks a significant milestone in its respective therapeutic category. Its scope hinges on specific chemical structures and therapeutic methods, carefully crafted to balance broad protection with validity robustness. Parsing its claims and understanding its positioning within the global patent landscape provides key insights into its commercial potential, infringement risk, and strategic value.


Key Takeaways

  • The patent's independent claims likely secure broad rights over a novel compound or therapeutic method, with dependent claims specifying narrower embodiments.
  • Its strength depends on demonstrated novelty, inventive step, and clear enablement, especially amidst existing prior art.
  • The patent landscape analysis suggests a competitive environment with numerous similar patents; strategic claim drafting is critical to protect market position.
  • The patent supports potential exclusivity and monetization avenues, including licensing or enforcement.
  • Continuous monitoring of subsequent legal challenges and patent filings is necessary to sustain the patent’s value.

FAQs

Q1: How does USPTO Patent 11,844,784 differ from prior art?
A1: It introduces a novel chemical structure or therapeutic approach that was previously undisclosed or non-obvious, establishing novelty and inventive step over prior art references.

Q2: Can the claims of this patent be challenged on grounds of obviousness?
A2: Yes, if prior art teaches similar compounds or methods, challengers can argue the claims are obvious, leading to potential reexamination or invalidation.

Q3: What is the typical lifespan of this patent, and when does it expire?
A3: Generally, utility patents in the U.S. last 20 years from the application filing date, subject to maintenance fees; thus, expiration is expected around 2043, assuming timely payments.

Q4: How does this patent impact generic drug entry?
A4: The patent’s claims, if upheld, can block generics for the patent term, delaying market entry. However, patent challenges or invalidation can open pathways for generics earlier.

Q5: What strategies can competitors employ around this patent?
A5: Competitors can design around the claims by developing structurally different compounds, seek licensing agreements, or challenge validity via post-grant proceedings.


Sources:

  1. USPTO Official Database.
  2. Patent family records and published applications.
  3. Patent classification systems (CPC/IPC).
  4. Industry reports on pharmaceutical patent strategies.

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Drugs Protected by US Patent 11,844,784

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity VIVIMUSTA bendamustine hydrochloride SOLUTION;INTRAVENOUS 212209-001 Dec 7, 2022 RX Yes Yes 11,844,784 ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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