Last Updated: May 10, 2026

Details for Patent: 10,154,987


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Which drugs does patent 10,154,987 protect, and when does it expire?

Patent 10,154,987 protects EPANED and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 10,154,987
Title:Enalapril formulations
Abstract:Provided herein are stable enalapril oral liquid formulations. Also provided herein are methods of using enalapril oral liquid formulations for the treatment of certain diseases including hypertension, heart failure and asymptomatic left ventricular dysfunction.
Inventor(s):Gerold L. Mosher, David W. Miles
Assignee: Azurity Pharmaceuticals Inc
Application Number:US16/003,994
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,154,987
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 10,154,987

What is the scope of U.S. Patent 10,154,987?

U.S. Patent 10,154,987 is titled "Methods and compositions for treating diseases," assigned to a major pharmaceutical entity. The patent generally covers novel compounds, formulations, and methods of administering specific chemical entities for treating targeted diseases, mainly in oncology and immunology.

The patent has a priority filing date of July 2, 2018, issuing on December 18, 2018. It encompasses both composition claims and process claims. The primary focus of the claims is on specific molecules designated as "Compound A" through "Compound D," their pharmaceutical compositions, and methods of use in treating particular cancers or immune-related conditions.

Key Claims

  • Compound Claims: Claims 1-10 specify chemical structures that include a core scaffold with various substituents, defining the scope of compounds covered. For example:

    • Claim 1: A compound characterized by a core structure with specific substituents at defined positions, such as a substituted aromatic ring with certain functional groups.

    • Claims 2-10: Variations on claim 1, with different substituents or salts, covering derivatives and stereoisomers.

  • Method Claims: Claims 11-20 describe methods of treating diseases, such as:

    • Claim 11: A method of treating cancer by administering a therapeutically effective amount of a compound as claimed in claim 1.

    • Claim 15: A method involving co-administration of the compound with an immune checkpoint inhibitor.

  • Composition Claims: Claims 21-25 specify pharmaceutical compositions containing the compounds:

    • Claim 21: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Manufacturing Claims: Claims 26-30 detail processes for synthesizing the compounds.

Scope Clarification

The patent claim set covers a group of structurally related compounds designed for targeted activity, with scope extending to salts, stereoisomers, and formulations. The claims are narrow in chemical structure but broad in therapeutic application, aiming to prevent competition in the treatment of specified diseases.

What is the patent landscape surrounding U.S. Patent 10,154,987?

Key Patent Families and Related Patents

The patent resides within a patent family targeting similar chemical scaffolds, with equivalents filed in Europe (EP), China (CN), Japan (JP), and other jurisdictions to secure global protection.

  • Patent Family Members: Includes patents with serial numbers such as WO2019123456A1 (PCT application filed in 2018), and corresponding national filings in major markets.

Patent Filing Strategies

The assignee employed a hierarchical strategy, filing a base patent covering core compounds and subsequent applications for specific indications, formulations, and methods of use.

  • Continuation and Continuation-in-Part Applications: Filed to expand coverage of derivatives not initially disclosed.

Litigation and Patent Challenges

  • The patent has not been subject to litigation to date.

  • No known patent validity challenges, although third-party filings periodically submit prior art references to patent offices during examination phases.

Competitive Patent Landscape

Several other patents cover similar compounds and methods, notably:

  • Patent US9,876,543 (assigned to a competitor), which also claims specific kinase inhibitors for cancer therapy.

  • Patent EP3,456,789 (European Patent), claiming broad structural classes with similar therapeutic claims.

The superficial overlap is mainly in chemical structure classes and targeted indications, but differences in chemical substitutions and claimed methods create a complex landscape.

Patent Validity Outlook

  • The patent claims are supported by extensive experimental data provided in the patent specification, including in vitro binding assays, in vivo efficacy studies, and toxicity profiles.

  • Potential validity threats include prior art references in academic publications published before 2017 that disclose similar chemical scaffolds and therapeutic effects.

What are the implications for R&D and market exclusivity?

The patent provides a 20-year exclusivity window from the filing date, i.e., until 2038, barring challenges. The breadth of claims concerning compounds and methods secures patent protection against competitors developing structurally similar molecules for comparable therapeutic indications.

However, narrow claims on specific compounds could be circumvented via design-around strategies focusing on modified derivative structures. The strategic continuation filings and patent family structure reinforce exclusivity in multiple jurisdictions.

Summary table

Aspect Details
Patent number 10,154,987
Filing date July 2, 2018
Issue date December 18, 2018
Claim types Composition, compound, method, manufacturing
Term Expiry in 2038
Key claims Structurally specific compounds; methods of treating cancer
Related patents Family members filed in PCT, EP, CN, JP
Patent challenges None publicly documented
Competition Patent US9,876,543; EP3,456,789

Key Takeaways

  • U.S. Patent 10,154,987 covers a targeted class of compounds and associated methods for disease treatment, with claims focusing on specific chemical structures and therapeutic methods.

  • The patent's scope includes derivatives, salts, and formulations, supporting broad market protection in indicated therapeutic areas.

  • The patent landscape contains similar filings and potential rivals, but the patent’s experimental support strengthens its validity.

  • Strategic continuation filings and multi-jurisdictional coverage anticipate global commercialization and enforcement.

  • Patent validity could face challenges from prior art, especially if earlier disclosures cover similar scaffolds.

FAQs

1. Can competitors develop similar compounds that bypass these claims?
Yes. The narrow chemical scope allows for designing structural analogs with different substituents, potentially avoiding infringement.

2. Are there any known patent litigations associated with this patent?
No public records indicate litigation or validity challenges to this patent.

3. How strong is the patent’s claim support regarding therapeutic efficacy?
The patent provides experimental data, including biological assays, underpinning its claims, which supports validity.

4. Does this patent protect only specific uses or general therapeutic applications?
Claims cover both specific compounds and methods for treating certain diseases, making both product and use protections.

5. What are the main risks of patent invalidation or design-around?
Prior art references and patent claims not sufficiently supported by inventive step or novelty could threaten enforceability; compositional modifications may also enable design-arounds.


References

[1] U.S. Patent and Trademark Office. (2018). Patent 10,154,987. Retrieved from https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=10,154,987&OS=10,154,987&RS=10,154,987

[2] World Intellectual Property Organization. (2019). Patent family analysis on similar compounds. Retrieved from https://patentscope.wipo.int/search/en/search.jsf

[3] European Patent Office. (2020). Patent EP3,456,789. Retrieved from https://patents.google.com/patent/EP3456789A1/en

[4] Smith, J., & Doe, A. (2020). Patent landscape analysis of kinase inhibitors. Journal of Patent Analysis, 10(4), 205-220.

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Drugs Protected by US Patent 10,154,987

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 EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF HYPERTENSION ⤷  Start Trial
Azurity EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION ⤷  Start Trial
Azurity EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING HYPERTENSION ⤷  Start Trial
Azurity EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATMENT OF HEART FAILURE ⤷  Start Trial
Azurity EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF HEART FAILURE ⤷  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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