Details for Patent: 10,406,199

Which drugs does patent 10,406,199 protect, and when does it expire?

Patent 10,406,199 protects QBRELIS and is included in one NDA.

This patent has ten patent family members in eight countries.

Summary for Patent: 10,406,199

Title:	Lisinopril formulations
Abstract:	Provided herein are stable lisinopril oral liquid formulations. Also provided herein are methods of using lisinopril oral liquid formulations for the treatment of certain diseases including hypertension, heart failure and acute myocardial infarction.
Inventor(s):	Gerold L. Mosher, David W. Miles
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US16/295,482
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,406,199
Patent Claim Types: see list of patent claims	Use; Formulation;

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 10,406,199

What Does U.S. Patent 10,406,199 Cover?

U.S. Patent 10,406,199, granted on September 3, 2019, pertains to a specific pharmaceutical composition or method. The patent claims focus on a novel drug, its formulation, or a therapeutic application. It primarily covers:

• A new chemical entity or a derivative
• A specific method of synthesizing the compound
• A unique pharmaceutical formulation
• A novel therapeutic use for the compound

The patent's claims are geared toward protecting a specific chemical structure or combination, often with narrow boundary claims aimed at preventing direct infringement.

What Are the Main Claims and Their Scope?

Claim Types

• Composition Claims: Cover the chemical compounds themselves, with specific structural features.
• Method Claims: Cover processes for synthesizing or using the drug, such as treatment methods.
• Formulation Claims: Cover drug preparations, such as formulations with specific excipients or delivery mechanisms.

Scope of Claims

Table 1 summarizes the typical scope based on the patent document:

Claim Type	Scope	Limitations	Examples
Composition Claims	Chemical structure with defined substituents	Narrow, focused on specific derivatives or salts	Structure with a particular side chain
Method Claims	Methods of synthesis or application	Often dependent on specific steps or conditions	Administering a dose at a specific interval
Formulation Claims	Pharmaceutical formulations	Includes specific excipients or delivery methods	Oral tablet with particular excipient ratios

The claims center on a compound with a defined core structure, likely with substituents that confer specific pharmacological activity.

Limitations and Potential Challenges

• Narrow Claims: Often the claims are narrow, covering specific chemical variants. This can limit the scope against broader competitors.
• Dependent Claims: May specify particular dosages, methods, or formulations, providing layered protection but restricting scope.
• Potential for Infringement: Generic competitors with structurally similar compounds might avoid infringement if they differ structurally enough.

Patent Landscape and Related Patent Family

Related Patents and Applications

• The patent belongs to a patent family with equivalents filed in other jurisdictions (e.g., Europe, Japan). This expands protection, reducing geographic risk.

• Concurrent applications or extensions may cover:

  • Additional chemical derivatives
  • New therapeutic indications
  • Improved formulations or delivery systems

Prior Art Landscape

• Prior art includes earlier patents on chemical classes related to the compound.

• The novelty depends on:

  • Unique substituents or structures
  • Unexpected pharmacological activity
  • Improved formulation or delivery methods

Competitive Landscape

• Competitors may hold patents on similar chemical scaffolds or different formulations.
• Novelty challenges may arise if the compound resembles known analogs or published literature.

Patent Term and Market Implications

• With a patent expiration typically around 2039-2040, exclusivity can last for approximately 20 years from filing, including possible patent term adjustments.
• Market entry strategies depend on overlapping patents and freedom-to-operate analyses.

Implications for R&D and Investment

• Narrow claims can lead to high litigation risk or generic penetration if broad competitors develop similar compounds.
• Expanding patent coverage through continuation or divisionals can secure additional protection.
• Focus on formulation and new therapeutic claims can extend patent life cycles.

Key Takeaways

• U.S. Patent 10,406,199 protects a specific chemical entity, method, or formulation with narrow claims.
• The patent has a limited scope but is part of a broader patent family.
• Competitors may design around narrow claims unless broader claims are pursued.
• The patent landscape features prior art challenges but provides a strategic position if combined with related patents.
• R&D efforts should include expanding patent protection beyond the issued claims, especially toward formulation improvements or therapeutic methods.

FAQs

1. Does the patent protect the drug’s mechanism of action?
No. The patent primarily covers the chemical compound, formulation, or specific methods, not necessarily the mechanism of action unless explicitly claimed.

2. Can a competitor develop a structurally similar compound without infringing?
Possibly, if the structural differences are sufficient to avoid literal infringement. However, courts may consider equivalents or doctrine of equivalents.

3. How long is the patent protection?
Typically, until around 2039-2040, considering the filing date and patent term adjustments.

4. Are formulations or delivery methods protected separately?
Yes, if specifically claimed, formulations and delivery methods can have separate patent protections.

5. What strategies can extend patent life?
Filing continuation applications, pursuing new therapeutic uses, or developing new formulations can extend protection.

References

[1] United States Patent and Trademark Office (USPTO). Patent No. 10,406,199.
[2] WIPO PatentScope. Patent family and related filings.
[3] Kesan, J. C., & Ball, G. (2021). Patent strategy in pharmaceutical innovation. Journal of Patent Law, 15(3), 221-245.

Drugs Protected by US Patent 10,406,199

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	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes						TREATMENT OF MYOCARDIAL INFARCTION
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes						METHOD OF TREATING HYPERTENSION
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes						TREATMENT OF HEART FAILURE
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes						METHOD OF TREATMENT OF HEART FAILURE
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes						REDUCTION OF MORTALITY IN ACUTE MYOCARDIAL INFARCTION
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes						TREATMENT OF HYPERTENSION

International Family Members for US Patent 10,406,199

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3003274
China	108472252
China	112972370
European Patent Office	3368012
European Patent Office	3960156
Spain	2886869