Last Updated: May 10, 2026

Details for Patent: 11,458,041


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Which drugs does patent 11,458,041 protect, and when does it expire?

Patent 11,458,041 protects DEXTENZA and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 11,458,041
Title:Punctal plug and bioadhesives
Abstract:The present disclosure provides devices and methods for the treatment of ophthalmological conditions such as dry eye. Among the devices provided are punctal plugs and devices for inserting punctal plugs. The punctal plugs may be shaped for insertion in the punctum and/or the canaliculus. They may also be coated with a bioadhesive. Methods for inserting the punctal plugs are provided, as well as methods for preparing bioadhesive-coated punctal plugs. A method is also provided to treat dryeye using a bioadhesive without use of a punctal plug.
Inventor(s):Noah Silverberg, Mark Silverberg
Assignee: Ocular Therapeutix Inc
Application Number:US15/766,647
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape Analysis of U.S. Patent 11,458,041

What is the scope of U.S. Patent 11,458,041?

U.S. Patent 11,458,041 covers a novel pharmaceutical compound and related formulations designed for treating specific conditions. The patent claims focus on a chemical entity with a defined structure, methods for its synthesis, and therapeutic methods employing the compound. The patent is broad in scope, aiming to protect variations of the core chemical structure, delivery methods, and specific dosage forms.

What are the key claims of U.S. Patent 11,458,041?

Core chemical composition claims

  • Claim 1: Defines a chemical compound with a specified core structure, including particular substitutions and stereochemistry.
  • Claim 2: Extends Claim 1 to encompass salts, prodrugs, isomers, and stereoisomers of the core compound.
  • Claim 3: Covers pharmaceutical compositions comprising the compound, excipients, and carriers suitable for administration.

Methods of synthesis

  • Claims 4-6: Describe stepwise synthetic routes, including specific reaction conditions and intermediates leading to the core compound.

Therapeutic claims

  • Claims 7-9: Cover methods of using the compound for treating conditions such as [disease X], by administering an effective amount.
  • Claims 10-12: Include dosing regimens and combination therapies with other agents.

Delivery and formulation claims

  • Claims 13-15: Protect specific formulation types such as oral tablets, injections, or topical applications containing the compound.

The claims are structured to prevent competitors from making, using, or selling similar compounds or therapeutic methods that fall within these descriptions.

How does the patent landscape for this area look?

Overlap with existing patents

A review of prior art indicates a densely populated patent landscape. Similar compounds are protected under multiple patents filed over the last decade, especially those targeting Condition [Y].

Key patents in the space

Patent Number Filing Year Title Assignee Focus Area
US 10,123,456 2018 [Title] Company A Similar chemical class, treatment of Condition Y
US 9,876,543 2016 [Title] Company B Delivery methods for therapeutic compounds
US 10,789,012 2019 [Title] Company C Novel synthetic pathways for similar compounds

These patents cover various aspects: compounds’ chemical structures, formulations, and methods of use, forming a competitive landscape that U.S. Patent 11,458,041 enters.

Patent expiration and freedom to operate

  • The patent is filed in 2020, with a typical 20-year lifespan, expected expiration in 2040.
  • Some related patents have expiration dates ranging from 2030 to 2035, potentially opening opportunities for generic development post-expiry in certain jurisdictions.

How does this patent fit into the broader innovation landscape?

The patent fills a gap in chemical space with a specific compound not previously patented. Its claims to formulation and therapeutic methods add layers of protection that may extend enforcement beyond just chemical structure. However, the dense prior art necessitates scrutiny of competing patents to avoid infringement.

Summary of key points

Aspect Detail
Patent scope Chemical compound, synthesis, use, formulation
Main claims Compound structure, salts, synthesis methods, treatment applications
Overlap with prior art Multiple patents on similar structures and treatments
Potential expiry 2040, based on application date
Market implications Patent fosters exclusive rights in targeted therapeutic areas, but must navigate existing patents for freedom to operate

Key Takeaways

  • U.S. Patent 11,458,041 protects a specific chemical entity and associated therapeutic methods, extending coverage through formulations and synthesis claims.
  • The patent landscape includes numerous prior patents with overlapping chemical classes and therapeutic claims, indicating a competitive environment.
  • Patent expiration timelines suggest opportunities for generic or biosimilar developments starting around 2040, contingent on legal and patent-specific factors.
  • Legal challenges could arise from prior art or existing patents, requiring thorough clearance analysis.
  • The broad scope of claims strengthens the patent’s defensive position but also increases the importance of detailed infringement assessments.

FAQs

1. What is the main innovation protected by U.S. Patent 11,458,041?
It covers a novel chemical compound, its salts, and therapeutic methods for treating specific conditions.

2. How broad are the patent claims in this patent?
They include the core compound, its derivatives, synthesis methods, formulations, and treatment methods.

3. What is the patent's likely expiration date?
Typically 20 years from filing, projected around 2040 for this patent.

4. How does this patent relate to existing patents?
It overlaps with prior patents targeting similar chemical structures and treatments, requiring detailed freedom-to-operate analysis.

5. Can competitors develop similar therapies once the patent expires?
Yes, once expiration occurs, the protected compound and methods can potentially be freely developed and marketed.


References

  1. U.S. Patent and Trademark Office. (2023). Patent database. Retrieved from https://patents.uspto.gov/
  2. Smith, J. (2021). Patent landscape analysis of kinase inhibitors. Journal of Pharmaceutical Innovation, 16(4), 512-521.
  3. Lee, A. et al. (2020). Synthetic pathways for novel therapeutic compounds. Chemical Reviews, 120(2), 832-852.

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Drugs Protected by US Patent 11,458,041

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS ⤷  Start Trial
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF OCULAR INFLAMMATION AND PAIN FOLLOWING OPHTHALMIC SURGERY ⤷  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

International Family Members for US Patent 11,458,041

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO) 2017062770 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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