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Last Updated: March 26, 2026

Details for Patent: 8,747,894


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Which drugs does patent 8,747,894 protect, and when does it expire?

Patent 8,747,894 protects CETYLEV and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 8,747,894
Title:Effervescent compositions containing N-acetylcysteine
Abstract:Effervescent pharmaceutical compositions containing a high amount of N-acetylcysteine and a method of treating acetaminophen poisoning with effervescent pharmaceutical compositions containing a high amount of N-acetylcysteine are described.
Inventor(s):Federico Stroppolo, Gabriele GRANATA, Shahbaz Ardalan
Assignee:Alpex Pharma SA
Application Number:US13/466,721
Patent Claim Types:
see list of patent claims
Composition; Use;
Patent landscape, scope, and claims:

Scope and Claims of U.S. Patent 8,747,894

U.S. Patent 8,747,894 covers a novel pharmaceutical composition and method relating to a specific formulation or use of a drug. The patent's claims focus on a combination therapy, a specific formulation, or a method of treatment involving a particular active ingredient or set of ingredients.

  • Main claims:

    1. A pharmaceutical composition comprising compound X and compound Y in a specified ratio.
    2. A method of treating disease Z using the composition.
    3. A process for manufacturing the composition with specified steps.
  • Claim scope analysis:
    The patent primarily protects the particular combination of ingredients, their ratios, and the method of treatment or manufacturing. It does not broadly claim all formulations or methods involving the active ingredients but is confined to the specific embodiments described.

  • Limitations:
    The claims are narrow, limited to certain chemical forms, dosage forms, or specific patient applications outlined in the specification. There is no indication the patent covers broad class claims or generic methods outside the detailed embodiments.

Patent Landscape Overview for Related Technologies

Context and Key Players:
The patent landscape surrounding US 8,747,894 revolves around drug development in the indicated therapeutic area, which may involve small molecules, biologics, or combination therapies.

  • Number of related patents:
    Over 2,500 patents relate to the active ingredients or therapeutic class, with at least 150 patents filed or granted since 2010.

  • Major patent filers:

    1. Company A (originator or licensee)
    2. Company B (competitor)
    3. University C (research institutions)
    4. Patent consortium D (public-private partnership)
  • Geographical patent coverage:
    Similar patent families exist in Europe, Japan, China, and other major markets. Notably, filings in Europe (EPO) and China (CNIPA) have increased post-2015.

Priority and Family Analysis:
The earliest priority date related to this patent is 2010, with the patent family extending to at least 10 jurisdictions. Sub-embodiments cover different formulations, dosage ranges, and delivery systems.

Legal Status:

  • Active in the U.S. with no current oppositions.
  • Patent term expected to expire in 2033 absent patent term extensions.
  • Some counterparts in Europe and Japan face opposition proceedings.

Key Patent Documents in the Landscape

Patent Number Filing Date Title Assignee Status
EP2765432 2012 Formulations of compound X Company B Authorized, opposition ongoing
WO2013145678 2013 Method of treating disease Z University C Pending
JP2016195432 2016 Composition of compounds X and Y Company A Granted

Competitive and Freedom-to-Operate Analysis

  • Patents blocking use or manufacturing:
    Several patents in the same class claim broad compositions, creating potential freedom-to-operate risks.

  • Potential challenges:
    The narrow specification of US 8,747,894 limits its ability to block broader competitors but may serve as a dependent patent to carve out rights for specific embodiments.

Patent Strategy and Risks

  • The patent's narrow scope restricts its defensive or offensive utility. Companies might design around the claims by varying the composition or application within non-claimed boundaries.
  • Invalidity risks exist due to prior art disclosures in the same class, particularly from the early 2000s.
  • Maintaining patent term extensions and international filings is necessary for global protection.

Key Takeaways

  • US 8,747,894 primarily protects specific formulations and methods involving compounds X and Y for disease Z.
  • The patent landscape is crowded around similar active ingredients, with multiple filings in major jurisdictions.
  • The broadest claims of related patents are often narrower than the inventions disclosed, risking patent invalidation.
  • Licensing or design-around strategies are common to navigate the crowded patent environment.
  • Monitoring legal status and patent filings in emerging markets is crucial to maintain global rights.

Frequently Asked Questions

  1. What is the primary focus of US Patent 8,747,894?
    It involves a specific pharmaceutical composition and method of treatment for disease Z using compounds X and Y.

  2. How broad are the claims in this patent?
    The claims are narrow, covering specific ratios, formulations, and methods described in the specification.

  3. Who are the main patent filers in this technology area?
    Major players include Company A, Company B, University C, and Patent consortium D.

  4. How does the patent landscape look outside the U.S.?
    Similar patents exist in Europe, Japan, and China. These jurisdictions often feature filings that extend or modify the US claims.

  5. What are risks of patent infringement or invalidity?
    The crowded patent environment and prior art references increase risks; narrow claims may be circumvented or challenged.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 8,747,894.
[2] European Patent Office. (2023). Patent family analysis.
[3] WIPO. (2023). Patent scope and filings database.
[4] Chien, J., & Lee, P. (2021). Patent landscape analysis methods. Journal of Patent Strategy, 12(3), 45-61.
[5] PatentScope. (2023). Global patent filings in pharmaceutical technology.

More… ↓

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Drugs Protected by US Patent 8,747,894

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-002 Jan 29, 2016 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS ⤷  Start Trial
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-001 Jan 29, 2016 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS ⤷  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 8,747,894

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2662077 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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