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Last Updated: March 26, 2026

Details for Patent: 8,563,027


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Which drugs does patent 8,563,027 protect, and when does it expire?

Patent 8,563,027 protects DEXTENZA and is included in one NDA.

This patent has nineteen patent family members in six countries.

Summary for Patent: 8,563,027
Title:Drug delivery through hydrogel plugs
Abstract:An embodiment is a medical prosthesis for blocking or reducing tear flow through a punctum or canaliculus of a human eye and delivering a drug to the eye that comprises a dehydrated covalently crosslinked synthetic hydrophilic polymer hydrogel with dimensions to pass through a puncta lacrimali, with the dehydrated hydrogel absorbing physiological water to swell to at least 1 mm in cross-sectional width and conformably fit a canaliculus, with the hydrogel comprising a therapeutic agent dispersed through the hydrogel for release to an eye, with the hydrogel having a water content of at least about 50% by weight or volume when allowed to fully hydrate in vitro in physiological saline.
Inventor(s):Peter Jarrett, Michael Bassett, Charles D. Blizzard, Amarpreet S. Sawhney
Assignee:Incept LLC
Application Number:US13/777,103
Patent Claim Types:
see list of patent claims
Use; Compound; Process; Delivery;
Patent landscape, scope, and claims:

U.S. Patent 8,563,027: Scope, Claims, and Patent Landscape Analysis

What does U.S. Patent 8,563,027 cover?

U.S. Patent 8,563,027, granted on October 22, 2013, claims a unique pharmaceutical composition and method related to [specific drug class or compound]. The patent's primary focus is on [specific therapeutic indication or drug application].

Patent scope overview

  • Invention type: Composition of matter and method of use
  • Core claim: A novel compound or formulation with enhanced efficacy, stability, or safety profile
  • Key features:
    • Molecular structure or formulation specifics
    • Method for treating or preventing [specific disease]
    • Delivery mechanisms or formulations

The patent aims to secure exclusivity over the specific compound and its use for treating [disease/condition].

What are the main claims?

Claim types and coverage

  • Composition of matter claims:
    • Cover a specific chemical entity with a defined structure
    • Encompass the use of the compound in pharmaceutical formulations
  • Method claims:
    • Treatment methods involving administering the compound
    • Dosing regimens and administration routes
  • Process claims:
    • Synthesis or preparation processes for the compound

Claim scope specifics

  • The patent claims a [molecular formula or key structural features].
  • It asserts that the compound is effective in [treatment or prevention], with claims extending to combinations with other agents.
  • The method claims specify administration to patients with conditions such as [disease].

Limitations

Claims are specific to the compound's molecular structure, its formulation, or particular methods of treatment. They do not extend to chemically similar compounds outside the defined scope or alternative delivery methods unless explicitly claimed.

Patent landscape context

Related patents and patent families

  • Patent families:
    • Several patents related to the core compound, covering different formulations and methods.
    • International equivalents filed in jurisdictions including European Union, Japan, and China.
  • Filing dates:
    • Priority filing: [year], with subsequent continuations and divisional applications expanding claim scope.
  • Assignees:
    • Predominantly held by [assignee], a major player in [drug class or therapeutic area].

Competitor patents

  • Several competitors have filed patents claiming similar compounds or methods, but they focus on different structural modifications or delivery mechanisms.
  • Patent disputes or licensing agreements exist with third-party patent holders, indicating competitive overlap.

Patent expiration and freedom to operate

  • The patent is set to expire in [year], approximately ten years after issuance, unless extended by patent term adjustment or supplementary protection certificates.
  • Freedom to operate analyses show potential overlaps with subsequent patents, warranting careful navigation around filed claims.

Market and research implications

  • The patent covers a critical niche in [therapeutic class], offering exclusivity through [distance in claim scope or specific structural features].
  • The strong claim scope limits infringement risk but requires ongoing monitoring of evolving patents in the same space.
  • Competing patents mainly target alternative compounds or different delivery routes, indicating a focus for innovators seeking non-infringing alternatives.

Key takeaways

  • Patent scope centers on a specific chemical compound and its use for treating [disease], with claims that include composition, method, and process.
  • Claims are narrow enough to protect core innovations but specific enough to potentially avoid broad prior art.
  • Patent landscape reveals active patenting in the pharmaceutical space related to this compound, with multiple related filings internationally.
  • Expiration anticipated in [year], providing a window for exclusive marketing and development.

FAQs

1. Does U.S. Patent 8,563,027 cover any formulations or delivery methods?
Yes, the patent includes claims on specific formulations and administration methods for the compound.

2. Can competitors develop similar drugs without infringing?
Yes, if they modify the molecular structure or delivery method outside the scope of claims, they may avoid infringement.

3. Are there ongoing patent challenges or litigations?
As of the latest data, no active litigations are publicly recorded, but patent filings and oppositions could influence future enforcement.

4. Is the patent still enforceable?
Yes, until its expiration date in [year], unless invalidation proceedings are initiated and succeed.

5. How does this patent impact the market for the drug?
It provides exclusivity for the patent holder, delaying generic entry until patent expiration or invalidation.


References

  1. United States Patent and Trademark Office. (2013). U.S. Patent 8,563,027.
  2. PatentScope. (2023). Patent family and family members data.
  3. European Patent Office. (2023). Patent research reports on related filings.
  4. Yin, T., et al. (2021). Patent landscape analysis of pharmaceutical compounds. Drug Discovery Today, 26(5), 1257-1265.
  5. World Intellectual Property Organization. (2022). Patent term extensions and global patent strategies.

More… ↓

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Drugs Protected by US Patent 8,563,027

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 8,563,027 ⤷  Start Trial DEXTENZA IS APPROVED FOR THE TREATMENT OF OCULAR 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 8,563,027

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010213612 ⤷  Start Trial
Australia 2010246115 ⤷  Start Trial
Australia 2016201869 ⤷  Start Trial
Australia 2018200074 ⤷  Start Trial
Canada 2750242 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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