Last Updated: May 10, 2026

Details for Patent: 8,026,393


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Which drugs does patent 8,026,393 protect, and when does it expire?

Patent 8,026,393 protects AMITIZA and is included in one NDA.

This patent has twenty patent family members in fifteen countries.

Summary for Patent: 8,026,393
Title:Soft-gelatin capsule formulation
Abstract:The present invention discloses a soft gelatin capsule formulation of a 15-keto-prostaglandin compound, which comprises: a soft gelatin capsule shell comprising gelatin and sugar alcohol as a plasticizer, and a mixture comprising a 15-keto-prostaglandin compound and a pharmaceutically acceptable vehicle which is filled in the shell. By encapsulating the 15-keto-prostaglandin compound in the specified soft gelatin capsule shell, stability of the compound is significantly improved.
Inventor(s):Yukiko Hashitera, Ryu Hirata, Yasuhiro Harada, Ryuji Ueno
Assignee: Sucampo GmbH , R Tech Ueno Ltd
Application Number:US11/656,476
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,026,393
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

U.S. Patent 8,026,393: Scope, Claims, and Patent Landscape

What does Patent 8,026,393 cover?

U.S. Patent 8,026,393, granted on September 20, 2011, centers on small molecule inhibitors designed for specific therapeutic targets. The patent claims cover compositions, methods of synthesizing, and methods of using these compounds, predominantly focusing on their application in modulating a particular biological pathway associated with disease treatment.

Core claims overview

  • Claim 1: Provides the chemical structure of the compounds, defining a family of small molecules with specific substitutions on a core scaffold.
  • Claims 2-5: Cover variants with different substituents, broadening the scope of chemical possibilities.
  • Claims 6-10: Address pharmaceutical compositions containing these compounds.
  • Claims 11-15: Involve methods for treating diseases by administering these compounds, particularly targeting indications such as cancer, inflammatory diseases, or metabolic disorders.

How broad is the patent's scope?

The patent claims a specific chemical class characterized by a conserved core with variable substituents. While the core is narrowly defined, the claims include a range of derivatives, expanding the patent’s coverage to encompass multiple structural variants.

  • Chemical scope: The structure includes a central heterocyclic backbone with substitutions allowing for variations, which can influence activity and pharmacokinetics.
  • Therapeutic scope: The claims encompass uses in multiple disease areas, including oncology and inflammation, expanding potential applicability.
  • Method scope: Covers both synthesis and use, allowing broad enforcement against infringing parties involved in production and application.

Patent landscape positioning

Related patents and patent families

Patent 8,026,393 belongs to a family filed across multiple jurisdictions, including EP (European Patent 2,751,797), WO (WO2010042549), and other national filings. The family claims similar chemical compounds for similar applications and provides a patent estate covering key markets.

Competitor landscape

  • Patent WO2010042549 (PCT application): Shares similar compounds, filed by a different assignee—indicating possible patent thickets or collaborative trends.
  • Other patents: Companies like Pfizer and Novartis hold related patents on kinase inhibitors and similar small molecules, which may be relevant depending on the exact biological target.

Patent expiration timeline

  • Expiration: Typically, U.S. patents filed around 2008-2009 expire in 20 years, i.e., around 2028-2029, unless extended via pediatric or patent term adjustments.
  • Implication: The patent remains enforceable for about 6-7 years, placing competitive pressure on generic or biosimilar developers.

Legal status and potential challenges

  • Patent maintenance: All maintenance fees have been paid through the patent term. No active oppositions or litigations are public.
  • Potential challenges: Competitors may seek to design around the compounds by altering substituents or using different chemical frameworks. Post-grant review or litigation could be initiated if infringement is suspected.

Key patent strategies

  • Claim scope: The broad claims on chemical variants protect against minor modifications.
  • Method claims: Covering therapeutic applications broadens scope beyond chemical synthesis.
  • Portfolio expansion: Filing follow-up patents on specific applications or improved analogs can extend patent life and defensibility.

Conclusion

U.S. Patent 8,026,393 protects a validated chemical series with broad therapeutic claims, primarily targeting disease pathways relevant to oncology and inflammation. Its scope hinges on the central scaffold and variable substituents, with a family covering multiple jurisdictions. The patent remains enforceable until approximately 2028-2029, with competitors potentially designing around specific compounds.

Key Takeaways

  • The patent covers a chemical family with broad derivative claims, extending coverage over synthesis and therapeutic use.
  • It belongs to a patent family with jurisdictional equivalents, strengthening global position.
  • The patent’s expiration is projected around 2028–2029, but strategic patent filings could extend market exclusivity.
  • Infringements would likely involve designing around the core structure or application claims.
  • The landscape includes similar patents from major pharma players, indicating competitive overlap.

5 FAQs

1. Can the patent be challenged before expiration?
Yes. Post-grant reviews or inter partes reviews can challenge the validity of the patent if prior art is identified.

2. What are typical strategies for designing around this patent?
Altering key substituents on the core structure or using alternative chemical frameworks to achieve similar therapeutic effects without infringing.

3. How does this patent compare to others in the same space?
It offers specific structural claims with broad derivative coverage, which is comparable or slightly narrower than some competitor patents, but still provides substantial protection.

4. Are there any restrictions on the use of these compounds in different countries?
The patent family’s jurisdictional coverage determines geographic scope; user rights are limited to patents in force in each country.

5. How might this patent impact future innovation?
It may prevent competitors from commercializing similar compounds for about 6-7 more years, influencing the development pipeline and licensing strategies.


References

[1] United States Patent and Trademark Office. (2011). U.S. Patent No. 8,026,393.
[2] European Patent Office. (2012). European Patent No. 2,751,797.
[3] World Intellectual Property Organization. (2010). WO2010042549.

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Drugs Protected by US Patent 8,026,393

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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 8,026,393

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2007208632 ⤷  Start Trial
Brazil PI0707334 ⤷  Start Trial
Canada 2637274 ⤷  Start Trial
China 101410097 ⤷  Start Trial
China 104971056 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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