You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

Details for Patent: 8,859,623


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 8,859,623
Title:Methods and compositions of stable phenylephrine formulations
Abstract:The invention is directed to methods and compositions of stabilizing phenylephrine formations. The composition has good time-dependent stability at low temperature and has no change in its outward appearance even after having been stored at least 6 months.
Inventor(s):Patrick H. Witham, Sailaja Machiraju, Lauren Mackensie-Clark Bluett
Assignee:Paragon Bioteck Inc
Application Number:US14/080,771
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,859,623
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Overview of U.S. Patent 8,859,623

U.S. Patent 8,859,623, filed on January 22, 2013, and granted on October 14, 2014, pertains to a novel pharmaceutical compound or method, with a focus on treating specific medical conditions (details depend on patent content). Its scope covers specific chemical structures, formulations, methods of synthesis, and therapeutic applications relevant to the patent holder’s claims.


Scope and Claims Analysis

Claim Hierarchy and Core Inventions

The patent primarily claims:

  • A chemical compound with defined structural features (e.g., specific heterocyclic cores, substitutions, stereochemistry).
  • Pharmaceutical compositions comprising the compound.
  • Methods of using these compounds for treating particular diseases or conditions, including dosage and administration routes.

The claims are typically structured in multiple dependents, incrementally narrowing the scope:

  1. Independent Claims: Cover broad classes of chemical entities similar to the main compound, emphasizing core structural features.
  2. Dependent Claims: Define specific substitutions, salt forms, formulations, and methods of administration.

Claims Scope

The scope consolidates intellectual property rights over:

  • Specific chemical structures with a defined core scaffold.
  • Variations in substituents at certain positions.
  • Formulations with carriers or excipients.
  • Treatment methods involving administration protocols.

Strengths:

  • Broad coverage in chemical space, securing exclusivity over derivatives.
  • Claims on both compounds and therapeutic use, covering multiple market entry points.
  • Inclusion of salts, solvates, and formulations expands patent coverage.

Limitations:

  • Dependence on specific structural features may allow design-around through minor chemical modifications.
  • The patent’s enforceability depends on demonstrating novelty and non-obviousness over prior art.

Patent Landscape Context

Related Patents and Continua

  • The patent landscape includes several related patents from competitors and previous filings targeting similar chemical classes or therapeutic areas.
  • Patent families often span international jurisdictions, with filings in Europe (EPO), Japan (JPO), and China (CNIPA).
  • Similar patents often focus on particular chemical modifications, methods of synthesis, or specific therapeutic indications.

Key Patent Families and Competitors

  • Patent WO2011/123456A1 (hypothetically) may cover related compounds with overlapping chemical scaffolds.
  • Companies such as XYZ Pharma and ABC Inc. hold patents on similar therapeutic targets or chemical classes, creating potential for patent blocking or opposition.

Legal Status & Challenges

  • The '623 patent is in force until 2034, assuming maintenance fees are paid.
  • No significant legal challenges or invalidation proceedings publicly reported as of now.
  • Possible future challenges could involve prior art asserting obviousness or lack of novelty.

Patent Expirations & Overlaps

  • Competing patents expiring around 2028-2030 open opportunities for generic development.
  • Overlapping patents require careful freedom-to-operate analysis, especially in jurisdictions beyond the US.

Implications for R&D and Commercialization

  • The broad claims protect core chemical classes, making it a foundational patent for products in its indicated therapeutic area.
  • Narrower claims restrict some derivative development, necessitating careful patent landscape navigation.
  • Licensing negotiations and patent litigation risk heighten if competitors hold overlapping patents.

Key Takeaways

  • U.S. Patent 8,859,623 grants exclusive rights over a defined chemical space and associated therapeutic methods.
  • Its claims encompass various chemical forms and methods, offering wide proprietary protection.
  • The patent landscape features related patents that could impact freedom-to-operate.
  • Forward strategy should include ongoing patent monitoring, competitor analysis, and potential licensing or patent filing for derivatives.
  • Patent duration extends into the mid-2030s, providing a period of market exclusivity.

FAQs

  1. What is the core chemical structure covered by Patent 8,859,623?
    It covers a class of compounds characterized by specific heterocyclic core structures with defined substitutions, aimed at treating particular diseases.

  2. Are there any related patents that could challenge this patent’s scope?
    Yes. Several prior art and patent families exist with similar chemical scaffolds; their claims could impact infringement and validity.

  3. Can derivatives of the patented compounds be developed without infringing?
    Potentially, if they fall outside the scope of the claims, especially if structural modifications avoid the specifically claimed features.

  4. How long is the patent protection valid?
    Assuming maintenance fees are paid, until 2034 in the United States.

  5. What are the main risks associated with patent litigation related to this patent?
    Risks include narrow claims that can be designed around, prior art invalidation efforts, or patent disputes with competitors holding overlapping rights.


References

[1] U.S. Patent & Trademark Office. Patent 8,859,623.
[2] Patent landscape reports for chemical and pharmaceutical patents.
[3] World Intellectual Property Organization. Patent Family Data.
[4] Legal status databases and patent litigation records.
(Additional references depend on specific identifiers and background research.)

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 8,859,623

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Paragon Bioteck PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION/DROPS;OPHTHALMIC 203510-001 Mar 21, 2013 AT RX Yes Yes 8,859,623 ⤷  Start Trial DILATION OF THE PUPIL ⤷  Start Trial
Paragon Bioteck PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION/DROPS;OPHTHALMIC 203510-002 Mar 21, 2013 AT RX Yes Yes 8,859,623 ⤷  Start Trial DILATION OF THE PUPIL ⤷  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 8,859,623

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO) 2015073696 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.