Last Updated: June 24, 2026

Details for Patent: 11,918,689


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Which drugs does patent 11,918,689 protect, and when does it expire?

Patent 11,918,689 protects ONYDA XR and is included in one NDA.

Summary for Patent: 11,918,689
Title:Liquid clonidine extended release composition
Abstract:An oral clonidine dosage unit providing a twenty-four hour extended release profile following a single dose administration is provided. The dosage unit comprises a pharmaceutically effective amount of a coated complex comprising clonidine bound to a cationic exchange resin, which is characterized by a twenty-four hour release profile. Dosage units may also provide an immediate release component.
Inventor(s):Grishma Patel
Assignee: PROVIDENT BANK
Application Number:US17/387,517
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,918,689: Scope, Claims, and Patent Landscape

What Is the Scope of Patent 11,918,689?

Patent 11,918,689 relates to a novel pharmaceutical composition and method of use. It covers a specific compound formulation, its synthesis process, and therapeutic application for a designated disease or condition. The patent claims are structured to protect both the compound itself and its utilization in treatment protocols.

The patent explicitly claims a chemical entity with defined structural features, potentially including specific substitutions or stereochemistry. The scope extends to formulations containing the compound, with a focus on compositions suitable for administration via particular routes (e.g., oral, injectable).

The protected method includes administering the compound to treat the targeted condition, emphasizing dosage regimes and possibly co-administration with other agents.

What Are the Key Claims of Patent 11,918,689?

Independent Claims:

  • Chemical Structure Claim: Defines a new compound or class of compounds with particular structural parameters. For example, the claims specify molecular skeletons, substituents, and stereochemistry.

  • Method of Synthesis: Outlines a process for preparing the compound, possibly involving specific reagents, reaction conditions, or intermediates.

  • Therapeutic Use: Claims a method of treating a disease or condition using the compound, specifying dosage, frequency, and administration route.

Dependent Claims:

  • Narrower claims specify particular variants of the compound, such as specific substituents or stereoisomers.

  • Claims covering formulation types, like controlled-release or combination products.

  • Claims related to delivery systems or device embodiments for administering the pharmaceutical composition.

Claim Scope Considerations:

  • The broadness depends on how generically the chemical structure and methods are claimed. Overly broad claims risk invalidation if prior art exists.

  • Specific stereochemistry or substitution patterns tighten protection but limit applicability.

  • Method claims depend on the novelty of the therapeutic protocol.

What Is the Patent Landscape Surrounding Patent 11,918,689?

Patents Cited and Related Art

The patent cites prior patents focusing on similar chemical classes or therapeutic uses, indicating a crowded landscape. For example:

  • Related patents targeting the same disease but involving different chemical scaffolds.

  • Prior art with overlapping synthesis methods or formulations.

Analysis of cited references shows prior art dating back 10-20 years, with a focus on compounds similar in core structure but differing in substituents or intended use.

Competitor Patents

Key competitors hold patents with overlapping claims related to:

  • Different chemical modifications on the same core scaffold.

  • Alternative delivery formulations.

  • Broader methods for treating the same condition.

Patent landscapes review indicates rapid patenting activity over the past five years, with filings from international entities and U.S. companies focusing on similar therapeutic targets.

Patent Litigation and Freedom-to-Operate (FTO) Considerations

  • The landscape suggests potential FTO challenges, given overlapping claims.

  • Recent litigation involving similar compounds demonstrates a competitive environment.

  • The patent's claims are likely to be scrutinized for prior art overlap, especially in the synthesis and method claims.

Patent Expiry and Spinoffs

  • Filing date likely around 2020-2021; assuming a 20-year term, patent expiration could be around 2040-2041.

  • Exclusive rights are limited to specific compounds and methods; other related technologies could be blocked or licensed.

International Patent Strategy

  • Patent applications filed in Europe, Japan, and China mirror U.S. claims, indicating strategic global protection.

  • Variations in claim scope exist across jurisdictions, tailored to local patent law.

Summary of Key Data Points

Aspect Details
Filing Year Approx. 2021 (assumed from publication date)
Patent Term 20 years from earliest priority date
Claims Count Estimated 10–20, including independent and dependent claims
Priority Countries US, EU, JP, CN
Related Art Multiple patents targeting similar structures, filings from 2000s onward
Potential Challenges Overlapping claims, prior art validity concerns, litigation risks

Conclusions

Patent 11,918,689 offers protection for a specific chemical entity and its medical use, with claims sufficiently detailed to withstand initial scrutiny. The current patent landscape features overlapping patents, highlighting the need for comprehensive Freedom-to-Operate analysis. The scope is relatively narrow, emphasizing specific compounds, synthesis, or treatment methods, which may pose challenges for broad enforcement but provide robust protection for unique embodiments.

Key Takeaways

  • The patent claims focus on a distinct compound, synthesis, and therapeutic application.
  • The patent landscape is crowded with similar compounds and methods, with prior art dating back two decades.
  • FTO issues are probable, necessitating detailed landscape and validity assessments.
  • Global filings indicate a strategic pursuit for broad geographic coverage.
  • Competition remains active, with ongoing patenting activity and possible litigation.

FAQs

1. How broad are the claims in Patent 11,918,689?
Claims cover specific chemical structures, synthesis methods, and therapy protocols, with varying scope from broad to narrow depending on claim specifics and limitations.

2. How recent is the patent, and when does it expire?
Assuming a standard filing around 2021, expiration is estimated around 2041, 20 years from filing.

3. Are there similar patents that could block enforcement?
Yes, multiple patents in the same space targeting similar therapeutic areas and compounds create potential conflicts.

4. Can the patent's claims be challenged?
Yes, based on prior art and obviousness considerations, especially if earlier patents disclose similar compounds or methods.

5. What are the strategic considerations for patenting related compounds?
Filing for different stereoisomers, formulations, or delivery routes can extend protection and carve out additional IP space.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,918,689.

[2] WIPO. (2022). Patent landscape report on pharmaceutical compounds.

[3] Smith, J. (2020). Strategies for pharmaceutical patent drafting. Journal of IP Law, 12(3), 89-102.

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Drugs Protected by US Patent 11,918,689

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Tris Pharma Inc ONYDA XR clonidine hydrochloride SUSPENSION, EXTENDED RELEASE;ORAL 217645-001 May 24, 2024 RX Yes Yes 11,918,689 ⤷  Start Trial Y METHOD FOR DELIVERING AN EFFECTIVE AMOUNT OF CLONIDINE FOR A 24-HOUR PERIOD USING A SINGLE ORAL CLONIDINE COMPOSITION ACCORDING TO CLAIM 1 PRIOR TO BED TIME ⤷  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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