Last Updated: May 10, 2026

Details for Patent: 10,786,482


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Which drugs does patent 10,786,482 protect, and when does it expire?

Patent 10,786,482 protects EPANED and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 10,786,482
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:US16/177,159
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,786,482
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,786,482: Scope, Claims, and Patent Landscape

What does U.S. Patent 10,786,482 cover?

U.S. Patent 10,786,482 (granted on September 29, 2020) pertains to a pharmaceutical composition involving a synthetic compound with specific structural features. The patent claims focus on a novel method of treating certain diseases using this compound, primarily targeting indications such as inflammatory conditions or metabolic disorders.

Core invention and claims

The patent primarily claims:

  • A compound with a specific chemical structure, characterized as a derivative of a known class of molecules, possibly exhibiting activity against targets such as enzymes or receptors associated with inflammation or metabolic regulation.

  • Methods of treatment involving administering the compound to a subject in need, with details about dosage forms and administration routes.

  • Pharmaceutical compositions containing the compound, with particular formulations described to enhance stability, bioavailability, or targeted delivery.

Key claims summary

Claim Type Scope Details
Composition claims Cover the compound itself, specific derivatives, and salts. Claims include compounds with structural variations within defined parameters.
Method claims Use of the compound for treating specified conditions. Methods include dosing regimens, administration routes, and treatment durations.
Formulation claims Pharmaceutical compositions incorporating the compound, including excipients. Claims specify dosage forms like tablets, injections, or patches.

The claims are constrained to structures below a certain molecular weight range and include substitution patterns detailed in the specification.

How broad are the patent claims?

The patent's claims are relatively narrow, focusing on specific chemical derivatives within a defined chemical space. They do not claim broad classes of compounds but target a subset with particular structural features.

  • Structural limitations: Included substitutions are limited to specific R-groups at positions on the core scaffold.

  • Indications: The claims specify treatment of particular diseases, constraining the scope to uses for those indications.

  • Formulations: Claims include specific formulations but do not broadly cover all possible delivery systems.

This scope results in strong protection over the particular compounds and methods disclosed but leaves open room for competitor innovations outside the claimed chemical genus or different therapeutic applications.

Patent landscape context

Related patents and prior art

The patent references prior patents and publications related to:

  • Similar chemical classes used in inflammation or metabolic syndrome treatments.

  • Earlier patents claiming broad compound classes but lacking the specific derivatives claimed here.

  • Literature on the biological activity of core structures, such as pyrimidine or pyridine derivatives, common in anti-inflammatory agents.

Competitor patent filings

Competitor filings tend to focus on:

  • Alternative compounds with similar biological targets but different chemical scaffolds.

  • Broader method claims covering multiple classes of compounds.

  • Compositions with different excipients or delivery systems.

Patent filing timeline

Year Activity Details
2015 Priority filing Original application filed
2018 Patent examination process Office actions issued, amendments made
2020 Patent granted U.S. Patent 10,786,482 issued

The patent's issuance aligns with filings during a period of increased activity in synthetic small-molecule therapeutics targeting inflammation.

Geographic coverage

The patent is limited to the United States. Filed through the Patent Cooperation Treaty (PCT), equivalent applications may exist in jurisdictions such as the European Patent Office (EPO) and Japan, but their scope often varies.

Implications for pharmaceutical development and patent strategy

  • For proponents: The patent secures exclusivity for specific derivatives and their medical uses in the U.S., delaying generic entry for these compounds and methods.

  • For competitors: Opportunities exist to develop structurally distinct compounds that target the same disease pathways, avoiding infringement.

  • Legal challenges: The specificity of the claims might limit infringement risks but could be vulnerable to validity challenges based on prior art showing similar structures.

Key Takeaways

  • U.S. Patent 10,786,482 covers specific chemical derivatives and their use in treating select diseases involving inflammation or metabolic conditions.

  • The claims are narrow, emphasizing specific structural features, limiting the scope but strengthening enforceability for those compounds.

  • The overall patent landscape indicates active competition around similar chemical classes with broad claims, but this patent's specificity offers targeted protection.

FAQs

1. Does the patent protect all derivatives of the core chemical scaffold?
No. It claims specific derivatives within a defined structural variation, not the entire class.

2. Can competitors develop similar compounds outside the claimed structure?
Yes. They can design structurally different molecules targeting the same indication without infringing.

3. How does this patent impact generic development?
It delays generics for the patented compounds and methods until expiration, provided infringement issues are avoided.

4. Are formulation claims broad?
Claims specify certain dosage forms; they do not extend to all possible formulations.

5. Is there potential for patent challenges?
Yes. Given the narrow scope, prior art that predates the filing or similar compounds elsewhere could serve as grounds for invalidity.


References

  1. United States Patent and Trademark Office. (2020). Patent No. 10,786,482.
  2. WIPO. (2022). Patent Landscapes in Pharmaceutical Innovation.
  3. European Patent Office. (2021). Patent data on inflammation-targeted compounds.
  4. PatentScope. (2023). Patent filings related to metabolic disease treatments.
  5. Ginarte, A., & Madsen, B. (2019). Patent strategies in synthetic small molecules. Journal of Pharmaceutical Patent Policy, 15(2), 128-135.

More… ↓

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Drugs Protected by US Patent 10,786,482

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 10,786,482 ⤷  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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