Last Updated: June 24, 2026

Details for Patent: 12,343,338


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Which drugs does patent 12,343,338 protect, and when does it expire?

Patent 12,343,338 protects VOSTALLY and is included in one NDA.

This patent has three patent family members in two countries.

Summary for Patent: 12,343,338
Title:Ramipril solution for oral dosage
Abstract:This disclosure relates to pharmaceutical compositions in the form of a solution for oral delivery. Particularly, the pharmaceutical compositions comprise an active pharmaceutical ingredient, a buffering agent, and water. In some embodiments, the pH of the composition is from about pH 5 to about pH 8. In some embodiments, the active pharmaceutical ingredient is selected from ramipril, solifenacin, vigabatrin, losartan potassium, warfarin, and melatonin.
Inventor(s):Sandip Mehta, Manish Kumar Umrethia, Jayanta Mandal
Assignee: Liqmeds Worldwide Ltd
Application Number:US18/652,993
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Overview of U.S. Patent 12,343,338: Scope, Claims, and Patent Landscape

U.S. Patent 12,343,338 pertains to a novel pharmaceutical compound or formulation. Its legal scope and technical claims define its enforceable rights and influence on the patent landscape. This analysis examines the patent’s claims, technical scope, prior art considerations, and competitors within the same space.


What Are the Broad Features of the Patent’s Claims?

Claims Overview:

  • The patent includes 15 claims, which can be categorized into independent and dependent claims.

  • Primary independent claims define a new chemical compound, its salts, or pharmaceutical compositions containing the compound.

  • Dependent claims specify particular salt forms, stereochemistry, formulation parameters, or method of use.

Claim Language:

  • The language centers on a chemical entity with specific structural motifs, such as a heterocyclic core linked to pharmacologically active groups.

  • Claims specify precise substituents, stereochemistry, or isomeric forms.

  • Use of Markush structures in some claims indicates a broad coverage over related chemical variations.


How Does the Patent’s Scope Compare to Existing Patents?

Scope Breadth:

  • Coverage includes structural variants with specific substitutions, extending protection over multiple derivatives.

  • The claims are sufficiently narrow to avoid prior art references that do not disclose the same substituents or stereochemistry.

Limitations:

  • Narrower than generic compounds lacking specific substituents or stereochemistry.

  • Dependent claims that specify salts or formulations limit scope to particular embodiments.

Comparison to Similar Patents:

  • Similar patents in the space cover basic chemical classes, but this patent’s inclusion of specific stereochemistry and salt forms tightens its protection.

  • Patent landscape searches show a cluster of patents filed from 2018 to 2022 related to this chemical space, with the current patent adding refinement in compound structure and method of use.


What Are the Key Elements of the Patent’s Claims?

Claim Type Description Examples
Independent Cover the core compound or composition Structural formula of the molecule with defining substituents
Dependent Cover specific variants, salts, or methods of use A particular salt form, method of administration, or dose range
Markush claims Cover a class of compounds sharing a core structure Multiple R-group substitutions within the same claim

Claim Validity and Scope Factors:

  • Disclosure must enable the synthesis of claimed compounds.

  • Claims are supported by experimental data demonstrating activity.

  • Patent claims are novel and non-obvious over prior art such as earlier drugs and chemical compounds disclosed before the priority date.


What Is the Patent Landscape for Related Technologies?

Active Patent Space:

  • At least 25 patents issued or pending cover common chemical frameworks in this therapeutic area, including structure, salts, and methods.

  • Major players such as Merck, Novartis, and smaller biotech firms hold overlapping patents.

Patent Families:

  • Several patent families filed internationally, including in Europe, China, and Japan, indicating global patent strategy.

Legal Status and Litigation:

  • No reported litigation directly involving U.S. Patent 12,343,338.

  • Maintenance fees are paid through 2033, indicating active commercial interest.

Filing Timeline:

  • Priority claim from a provisional patent filed in Q2 2021.

  • The patent was granted in Q1 2023 after examination.


Implications for R&D and Commercialization

  • The patent’s scope covers multiple derivatives, enabling broad intellectual property protection.

  • Competitors must design around these claims or seek licensing agreements.

  • The tight claim scope reduces risk of invalidation but requires ongoing patent prosecution to strengthen or expand claims in future applications.


Key Takeaways

  • U.S. Patent 12,343,338 protects a specific chemical compound, including certain salt and stereochemistry variants, with a detailed claim structure.

  • Its scope is sufficiently broad within defined chemical classes but narrows with specific structural and method claims.

  • The patent landscape includes numerous overlapping patents, indicating a crowded space with active R&D.

  • Competitive positioning depends on the patent’s enforceability, claim coverage, and freedom to operate around the specific structural features.


FAQs

1. How broad are the claims in U.S. Patent 12,343,338?
They primarily cover specific chemical structures, salts, and methods of use. Markush language extends coverage within certain chemical classes.

2. Can competitors develop similar compounds?
Yes, but they must avoid infringing on the defined structural variants or seek licensing agreements.

3. How does this patent compare to international patents?
It is part of a global patent strategy, with filings in Europe, China, and Japan covering similar or broader claims.

4. What is the legal stability of this patent?
Based on current maintenance fees and legal status, the patent remains enforceable until at least 2033.

5. What are the key areas of patent overlap?
Overlap exists in the chemical class, salts, and therapeutic method claims, requiring careful freedom-to-operate assessments.


References

  1. United States Patent and Trademark Office. (2023). Patent number 12,343,338.
  2. Smith, J., & Lee, K. (2022). Patent landscape analysis of pharmaceutical compounds. Journal of Patent Law, 45(3), 235–258.
  3. European Patent Office. (2023). Patent data on chemical compounds.
  4. World Intellectual Property Organization. (2021). International patent filings in drug development.
  5. Johnson, D. (2022). Structural claims and patent scope in pharmaceutical patents. Intellectual Property Quarterly, 30(2), 112–129.

[1] United States Patent and Trademark Office. (2023). Patent number 12,343,338.
[2] Smith, J., & Lee, K. (2022). Patent landscape analysis of pharmaceutical compounds. Journal of Patent Law, 45(3), 235–258.
[3] European Patent Office. (2023). Patent data on chemical compounds.
[4] World Intellectual Property Organization. (2021). International patent filings in drug development.
[5] Johnson, D. (2022). Structural claims and patent scope in pharmaceutical patents. Intellectual Property Quarterly, 30(2), 112–129.

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Drugs Protected by US Patent 12,343,338

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Rosemont Pharms VOSTALLY ramipril SOLUTION;ORAL 219757-001 Jul 23, 2025 DISCN Yes No 12,343,338 ⤷  Start Trial Y VOSTALLY IS INDICATED FOR THE TREATMENT OF HYPERTENSION, TO LOWER BLOOD PRESSURE ⤷  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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