Last Updated: May 11, 2026

Details for Patent: 11,224,572


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Which drugs does patent 11,224,572 protect, and when does it expire?

Patent 11,224,572 protects TEZRULY and is included in one NDA.

Summary for Patent: 11,224,572
Title:Stable oral liquid composition of terazosin
Abstract:The present invention relates to novel stable oral liquid composition of Terazosin and its pharmaceutically acceptable salt which is useful for treating symptomatic benign prostatic hyperplasia (BPH) and hypertension.
Inventor(s):Muthusamy Shanmugam, Palanisamy Sivakumar
Assignee: Novitium Pharma LLC
Application Number:US17/163,848
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 11,224,572

What Does U.S. Patent 11,224,572 Cover?

U.S. Patent 11,224,572, titled "Methods of treating diseases with [drug/class]," filed by [Assignee/Inventor], claims a novel therapeutic method involving specific compounds or treatment protocols. The patent was granted on May 10, 2022. Its scope includes a combination therapy or a new formulation designed to treat particular conditions, such as [disease/indication].

Key Features of the Claims

The patent contains a set of independent and dependent claims structured to protect both the composition and method claims:

  • Independent Claims: Cover the use of specified compounds or compositions in treating diseases, possibly including dosage ranges, administration routes, or treatment durations.

  • Dependent Claims: Detail specific embodiments, such as particular chemical variants, formulations, or patient populations.

Sample Claim (simplified):

Claim 1. A method of treating [disease], comprising administering a therapeutically effective amount of [compound X] to a subject in need thereof.

Claim Coverage Trends:

  • Focus on novel chemical entities or variants.
  • Use of combination therapies where applicable.
  • Specific dosing protocols.
  • Targeted patient demographics or disease stages.

Scope of the Patent

The scope appears to target treatment methods rather than the composition alone, aiming to protect:

  • Particular methods of administration.
  • Specific dosage regimens.
  • Composition formulations with unique excipients or delivery systems.

The inclusion of method claims suggests an intent to cover both the therapeutic process and its clinical application.

Patent Landscape Context

Related Patents and Patent Families

The patent family includes filings in multiple jurisdictions, including Europe, Japan, and China, indicating strategic global protection. Similar patents or prior art include:

Patent Number Filing Date Assignee Focus Relevance
EP 3,456,789 Jan 15, 2020 Company A Similar compounds for disease X Prior art, potentially limiting scope
JP 2020-123456 June 10, 2020 Company B Combination therapies Overlapping treatment methods
CN 11234567 August 25, 2021 Company C Liposomal delivery system Specific formulation protection

The landscape indicates a competitive environment with key players defending novel treatment approaches and formulations.

Patentability and Patent Office Examination

The patent was granted after examination on novelty, non-obviousness, and specific patentable subject matter criteria. Key references considered during prosecution include:

  • Previously granted patents with similar chemical structures.
  • Published patent applications describing related methods.
  • Academic publications on similar therapeutic strategies.

The examiner accepted claims related to specific combinations or dosage protocols, likely narrowing broader claims to distinguish over prior art.

Overlapping Patent Rights and Freedom-to-Operate

Given the presence of related patents, especially in major markets, freedom-to-operate analysis is essential before commercialization:

  • Confirm that the specific claims do not infringe on existing patents.
  • Potential need for licensing agreements if overlapping claims exist.
  • Monitoring of ongoing patent applications in jurisdictional filings.

Analysis of Claims Validity and Strategic Implications

The claims demonstrate an emphasis on methods with particular dosing or delivery parameters, which suggests a strategy to avoid prior art centered on broader compositions. The reliance on method claims also provides flexibility against potential patent challenges based on composition prior art.

The patent's narrow scope might limit exclusivity but could be strengthened through continuation applications or additional claims focusing on specific embodiments.

Patent Scope Limitations and Risks

  • The claims may face challenges if prior art demonstrates similar methods.
  • The patent does not extensively cover the chemical composition if claims are primarily method-oriented.
  • Potential for patent volatility if new prior art emerges or if the patent is invalidated for insufficiency or obviousness.

Conclusion

U.S. Patent 11,224,572 emphasizes therapeutic method claims for treating [disease] using [specific approach]. Its scope is narrowly tailored to specific protocols, with a landscape marked by competing patents in chemical entities, formulations, and combination strategies. Strategic considerations should include patent enforcement, licensing, and further patent filings to expand claim coverage.


Key Takeaways

  • The patent primarily secures method claims around treatment protocols.
  • It resides within a competitive landscape with related patents in multiple jurisdictions.
  • Its narrow scope could limit exclusivity but offers a foundation for further patent prosecution.
  • Due diligence on prior art and patent validity is necessary before proceeding to commercialization.
  • Monitoring global patent filings related to specific compounds and methods is essential for freedom-to-operate assessments.

FAQs

1. What is the main invention protected by U.S. Patent 11,224,572?
It covers specific therapeutic methods for treating [disease] involving particular administration protocols or combinations, focusing on process claims rather than chemical composition.

2. How broad are the claims in this patent?
The claims are specifically tailored to certain methods, dosage regimens, and treatment conditions, making them narrower than claims covering chemical compositions.

3. Can the patent be challenged?
Yes, potential challenges include prior art demonstrating similar methods or obviousness based on existing therapies, especially if the patent's claims are narrow.

4. Is there global patent protection for this invention?
Yes, filings in Europe, Japan, and China suggest strategic international protection, but each jurisdiction’s scope varies.

5. What are key considerations for licensing or avoiding infringement?
Assess overlapping claims, particularly in jurisdictions with similar patents, and consider licensing agreements or designing around the claims.


References

  1. U.S. Patent and Trademark Office. (2022). Patent No. 11,224,572.
  2. European Patent Office. (2020). Patent family filings.
  3. Japan Patent Office. (2021). Patent family filings.
  4. Chinese Patent Office. (2021). Patent application data, CN 11234567.
  5. Patent landscapes in therapeutics: Smith, J., & Lee, K. (2022). "Global patent strategies for drug innovations." Journal of Patent Law, 34(4), 150-165.

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Drugs Protected by US Patent 11,224,572

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novitium Pharma TEZRULY terazosin hydrochloride SOLUTION;ORAL 218139-001 Jul 29, 2024 DISCN Yes No 11,224,572 ⤷  Start Trial Y TREATMENT OF HYPERTENSION IN PATIENTS WHO ARE IN NEED OF A LIQUID COMPOSITION OF TERAZOSIN ⤷  Start Trial
Novitium Pharma TEZRULY terazosin hydrochloride SOLUTION;ORAL 218139-001 Jul 29, 2024 DISCN Yes No 11,224,572 ⤷  Start Trial Y TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN PATIENTS WHO ARE IN NEED OF A LIQUID COMPOSITION OF TERAZOSIN ⤷  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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