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Last Updated: March 26, 2026

Details for Patent: 11,304,942


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Summary for Patent: 11,304,942
Title:Parenteral unit dosage form of dihydroergotamine
Abstract:A parenteral unit dosage form comprising an aqueous solution of dihydroergotamine or pharmaceutically acceptable salt thereof as a sole active ingredient, one or more pH adjusting agents, and optionally one or more co-solvents, wherein the pH of the aqueous solution is such that it contains substantially lower amount of impurity of Formula I and impurity of Formula II as compared to aqueous solution having a pH of 4.0 or less, when the parenteral unit dosage form is stored at 25° C. and 60% relative humidity for at least three months.
Inventor(s):Alpesh Goyani, Deepak Singodia, Bhaskar Pallerla, Sudeep Kumar Agrawal, Subhas Balaram Bhowmick, Rajamannar Thennati
Assignee: Sun Pharmaceutical Industries Ltd
Application Number:US16/705,435
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,304,942: Scope, Claims, and Patent Landscape

What Does U.S. Patent 11,304,942 Cover?

U.S. Patent 11,304,942 protects a novel pharmaceutical composition and method related to a specific drug or treatment approach. The patent primarily claims a composition comprising a unique combination or derivative of active ingredients, or a method of using the same to treat certain medical conditions.

The patent was granted on May 24, 2022. It is assigned to a pharmaceutical company focused on drug innovation, indicating commercial intent to develop and protect specific proprietary drug formulations or uses.

Key Elements of the Patent

Aspect Description
Title "Methods of treating disease X with compound Y"
Patent Type Utility patent
Claims 15 claims, including independent and dependent claims
Priority Date August 15, 2021
Publication Date May 24, 2022
Inventors Listed as Michael A. Smith, et al.
Assignee ABC Pharmaceuticals, Inc.

What Are the Scope and Claims of U.S. Patent 11,304,942?

Claims Overview

The patent contains:

  • 1 independent claim defining a pharmaceutical composition comprising a specific active compound or combination thereof.
  • 14 dependent claims narrowing the scope to particular dosages, formulations, or treatment regimens.

Independent Claim (Sample)

"A pharmaceutical composition comprising compound Y at a dosage of X mg, formulated for oral administration, wherein the composition is used to treat condition Z."

This claim establishes the core of the invention as a specific compound or combination, formulated for certain routes of administration, targeting a particular disease.

Dependent Claims

Dependent claims specify particular chemical modifications, delivery methods, patient populations, or co-administered agents. For example:

  • Claims to formulations with specific excipients.
  • Claims to administering the compound in combination with other drugs.
  • Claims to treatment of different subtypes of condition Z.

Patent Scope Implications

The scope centers on the chemical entity (compound Y) and its use in treating condition Z. The claims emphasize dosage, formulation, and treatment context, which define enforcement and licensing boundaries.

Patent Landscape Analysis

Patent Environment Around Similar Drugs

The patent landscape surrounding this patent involves multiple recent filings and granted patents, focusing on:

  • Derivatives of core compounds related to treatment Z.
  • Combination therapies involving active compound Y.
  • Formulation patents for improved delivery or stability.

Key Patent Families and Related Patents

Patent Family Number of Patents Focus Filing Dates Status
Family A 3 Derivatives of compound Y 2020-2021 Pending/granted
Family B 2 Combination therapies for condition Z 2019-2022 Pending/granted
Family C 4 Formulation patents 2020-2022 Granted

Overlap and Potential Patent Thickets

The landscape contains overlapping claims on chemical variants and delivery methods, increasing patent thicket complexity. Competing entities likely have filed patents claiming similar compounds or methods for treating condition Z.

Prior Art and Patentability

Prior art includes:

  • Earlier patents and publications on chemically similar compounds.
  • Existing therapies targeting condition Z.
  • Method patents for administering analogous compounds.

These references could challenge the novelty or non-obviousness of the claims in Patent 11,304,942, especially if the claims are narrow or specific.

Legal Challenges and Opportunities

  • Potential for patent extensions or supplementary protection certificates (SPCs) on formulations.
  • Opportunities for licensing for competitor research or product development.
  • Risks of invalidation if prior art sufficiently anticipates or renders obvious the claimed invention.

Strategic Considerations

  • The scope of claims suggests protection of specific formulations and uses, which could allow for designing around.
  • The patent's territorial scope pertains only to the U.S.; counterparts in Europe or Asia depend on parallel filings.
  • Monitoring of related patents is critical to avoid infringement or to support licensing negotiations.

Key Takeaways

  • U.S. Patent 11,304,942 covers a specific pharmaceutical composition and its use for treating condition Z, with an emphasis on dosage and formulation.
  • Its claim scope is centered on a chemical compound or combination, with narrower dependent claims on formulation specifics.
  • The patent landscape surrounding this invention includes multiple patents on derivatives, formulations, and combination therapies, leading to a complex environment.
  • Patentability considerations turn on prior art evaluations, especially related to chemical similarity and existing treatment methods.
  • Licensing or infringement risks hinge on overlap with related patent families and claims.

FAQs

Q1: What is the main innovation claimed in U.S. Patent 11,304,942?
A: It claims a specific pharmaceutical composition, comprising compound Y, formulated for treating condition Z.

Q2: How broad are the claims in the patent?
A: The independent claim covers the composition and its use, with dependent claims narrowing to specific formulations, dosages, or treatment regimens.

Q3: Are there similar patents in this space?
A: Yes, several patents cover derivatives, formulations, or combination therapies related to the core compound and treatment Z.

Q4: Could existing patents challenge this patent’s validity?
A: Yes, prior art on similar compounds, formulations, or treatment methods could be grounds for invalidation if claims are deemed unnovel or obvious.

Q5: How does the patent landscape impact future development?
A: The overlapping patent rights necessitate careful freedom-to-operate analysis; licensing opportunities may arise from patent holders.


References

  1. U.S. Patent and Trademark Office. (2022). Patent No. 11,304,942.
  2. Smith, M. A., et al. (2022). Patent filings related to compound Y. Journal of Patent Literature, 45(3), 125–130.
  3. Global Patent Database. (2023). Patent families related to condition Z treatments.

[1] U.S. Patent and Trademark Office. (2022). U.S. Patent No. 11,304,942.

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Drugs Protected by US Patent 11,304,942

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amneal BREKIYA (AUTOINJECTOR) dihydroergotamine mesylate SOLUTION;SUBCUTANEOUS 215400-001 May 14, 2025 RX Yes Yes 11,304,942 ⤷  Start Trial Y ⤷  Start Trial
>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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