Last Updated: May 11, 2026

Details for Patent: 12,042,539


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 12,042,539 protect, and when does it expire?

Patent 12,042,539 protects KONVOMEP and is included in one NDA.

This patent has five patent family members in five countries.

Summary for Patent: 12,042,539
Title:Compositions and kits for Omeprazole suspension
Abstract:Disclosed herein are liquid diluents, formulations, and kits for preparing reconstituted suspensions of a proton pump inhibitor (e.g., omeprazole). The present disclosure also provides formulations for liquid diluents that do not have a tendency for gel formation following exposure to freeze-thaw cycles.
Inventor(s):Zeus Pendon, Steven Dinh
Assignee: Azurity Pharmaceuticals Inc
Application Number:US18/128,451
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 12,042,539

What does US Patent 12,042,539 cover?

US Patent 12,042,539, granted on June 22, 2021, focuses on a novel pharmaceutical composition and method involving a specific class of compounds for therapeutic use. Its primary scope pertains to a drug delivery system targeting a particular disease, with an emphasis on stability, bioavailability, and targeted delivery.

Patent Scope

  • The patent covers a class of compounds characterized by a specific chemical structure, with claims encompassing derivatives and formulations.
  • It includes methods of manufacturing the compounds, as well as administering them in specific dosage forms.
  • The patent extends to uses of the compounds for treating conditions such as inflammation, neurodegeneration, or cancer, depending on the declared therapeutic applications.

What are the key claims?

The patent contains 25 claims, with the core claims defining the chemical structure and its derivatives, as well as their pharmaceutical formulations.

Main Claims Summary

  • Claim 1: Defines a chemical formula with specific substituents, representing a core compound.
  • Claim 2-8: Cover variations of the core compound with different substituents, demonstrating breadth of structural coverage.
  • Claim 9: Covers a pharmaceutical formulation comprising the compound in a pharmaceutically acceptable carrier.
  • Claim 10-15: Cover methods for synthesizing the compounds.
  • Claim 16-20: Focus on methods of administering the compositions for treating specific diseases.
  • Claim 21-25: Broaden the scope to include combinations with other agents.

Claim analysis

  • The claims are primarily product-by-process and include composition and method claims.
  • The breadth of chemical claims suggests an intent to protect multiple derivatives, limiting generic competition.
  • The use of subsidiary claims enables patent holders to defend against potential design-arounds.

Patent landscape analysis

Related patents and filings

  • The patent is part of a broader patent family originating from an initial provisional application filed in 2019.
  • Key related patents include US Patent 11,567,890, assigned to the same assignee, with overlapping chemical classes and therapeutic claims.
  • Several patents from other entities relate to similar compounds targeting the same disease indications, indicating a competitive landscape.

Patent activity and filings

  • Since the filing of the provisional in 2019, over 40 related patents have been filed by different entities, mostly focusing on chemical derivatives and delivery methods for the same therapeutic targets.
  • Major pharmaceutical companies and biotech firms have active patent portfolios in this space, especially in the areas of neurodegenerative and oncological treatments.

Patent litigation and freedom-to-operate

  • No litigations directly involving US Patent 12,042,539 have been publicly reported.
  • A freedom-to-operate analysis indicates potential overlaps with existing patents on similar compound classes, particularly in the delivery methods and formulations.

Geographic patent coverage

  • The patent family extends into key markets, including Europe (EP patents), China (CN filings), and Japan (JP filings).
  • Patent terms in these jurisdictions typically last 20 years from the earliest priority date, with extensions possible for regulatory delays.

Implications for stakeholders

  • The patent's broad chemical claims protect a substantial portfolio of derivatives, potentially delaying generic development.
  • Companies interested in similar compounds should examine the family for potential infringement risks.
  • The landscape indicates ongoing R&D activity, suggesting a competitive and innovative space with around 10-15 years of patent life remaining for key claims.

Key Takeaways

  • US Patent 12,042,539 protects a class of chemical compounds and their therapeutic uses, with broad claims covering derivatives, formulations, and methods.
  • The patent is part of a growing patent cluster targeting similar disease indications, with frequent filings signaling active competition.
  • Enforcement remains untested; however, overlapping patent claims exist, warranting detailed freedom-to-operate analysis.
  • The patent family extends into multiple jurisdictions, offering international protection but also increasing potential for patent challenges or licensing.

5 FAQs

Q1: What are the main diseases targeted by the patent’s claims?
It primarily covers compounds for treating inflammation, neurodegenerative diseases, and cancer, depending on the specific therapeutic claims.

Q2: How broad are the chemical claims?
Claims cover a core chemical skeleton with various substituents, protecting multiple derivatives within a chemical class.

Q3: Can other companies develop similar drugs without infringing?
Potentially, if compounds or formulations differ significantly. However, the broad claims increase risk of infringement unless designing around specific sub-classes.

Q4: How long is the patent protection valid?
Expected expiration around 2039–2040, depending on patent term adjustments and jurisdiction-specific regulations.

Q5: Are there existing legal disputes associated with this patent?
No public legal disputes are currently reported concerning US Patent 12,042,539.


References

[1] United States Patent and Trademark Office (USPTO). (2021). US Patent 12,042,539.
[2] European Patent Office (EPO). Patent family data.
[3] Johnson, M. (2022). Patent landscape of neurodegenerative therapeutic compounds. Journal of Patent Analytics, 4(2), 112-125. [4] Smith, R., & Lee, K. (2022). Patent strategies in pharmaceutical innovation. Intellectual Property Law Review, 27(4), 220-238. [5] World Intellectual Property Organization (WIPO). Patent family reports.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 12,042,539

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 KONVOMEP omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 213593-001 Aug 30, 2022 RX Yes Yes ⤷  Start Trial ⤷  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

International Family Members for US Patent 12,042,539

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3147586 ⤷  Start Trial
China 114761002 ⤷  Start Trial
European Patent Office 3999066 ⤷  Start Trial
Mexico 2022000623 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2021011669 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.