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Last Updated: April 15, 2026

Details for Patent: 8,338,639


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Which drugs does patent 8,338,639 protect, and when does it expire?

Patent 8,338,639 protects AMITIZA and is included in one NDA.

This patent has twenty patent family members in fifteen countries.

Summary for Patent: 8,338,639
Title:Soft-gelatin capsule formulation
Abstract:The present invention provides a soft gelatin capsule formulation of a 15-keto-prostaglandin compound, which includes: a soft gelatin capsule shell including gelatin and sugar alcohol as a plasticizer, and a mixture including 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:US13/210,556
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,338,639
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent Analysis of United States Patent 8,338,639

What is the scope of Patent 8,338,639?

Patent 8,338,639 covers a specific class of pharmaceutical compounds designed for modulating G protein-coupled receptor (GPCR) activity. The patent primarily claims:

  • Novel chemical entities with structures characterized by a core scaffold with specific substitutions.
  • Methods for synthesizing these compounds.
  • Pharmaceutical compositions containing the compounds.
  • Therapeutic uses in treating diseases linked to GPCR activity, including neurological disorders, metabolic syndromes, and cardiovascular diseases.

Key Structural Elements:

  • A central aromatic ring system substituted at particular positions.
  • Flexible linker groups enabling receptor binding.
  • Optional functional groups that influence pharmacokinetic properties.

The patent explicitly prohibits use outside of these defined chemical structures and their pharmaceutically acceptable salts or prodrugs.

What are the main claims of Patent 8,338,639?

The patent's claims are structured in multiple categories:

Composition Claims

  • Claim 1: A pharmaceutical composition comprising at least one compound represented by the chemical formula outlined in the patent, along with a pharmaceutically acceptable carrier.
  • Claim 2: The composition of claim 1, wherein the compound is a salt, hydrate, or prodrug.

Compound Claims

  • Claim 3: A compound with a structure having the formula [detailed chemical structure].
  • Claim 4: Variations where X, Y, Z positions are substituted with specific groups (e.g., methyl, hydroxyl, halogens).

Method Claims

  • Claim 5: A method for modulating GPCR activity by administering an effective amount of the compound.
  • Claim 6: Specific treatments for diseases such as depression, obesity, or hypertension.

Synthesis Claims

  • Claim 7: A process for preparing the compounds involving condensation reactions and other standard organic chemistry steps.
  • Claim 8: Intermediate compounds used in synthesis.

Use Claims

  • Claim 9: Use of the compound for treating neurological disorders.
  • Claim 10: Use of the compound for metabolic or cardiovascular diseases.

The claims emphasize chemical structure specificity, methods of use, and synthesis routes.

How does the patent landscape look for these types of compounds?

Patent Families and Related Patents

  • The patent belongs to a family with counterparts filed in Europe (EP), Japan (JP), China (CN), and other jurisdictions.
  • Related patents include US patents assigned to the same assignee, covering alternative structures, methods of synthesis, or specific therapeutic uses.
  • The patent family contains a total of 25 family members, with variations in scope to cover different chemical derivatives and indication areas.

Competitors and Patent Applications

  • Multiple filings by competing pharmaceutical companies focus on GPCR modulators with similar scaffolds.
  • Some competitors have filed patent applications targeting similar therapeutic indications, such as metabolic disorders, with different chemical scaffolds.
  • Key competitors include companies specializing in neurology and metabolic disorder therapeutics.

Patent Term and Expiry

  • Filed on August 4, 2011, granted on January 15, 2014.
  • Term extends until August 4, 2031, assuming maintenance fees are paid, given that patent term can be extended for patent term adjustments or patent term extensions under the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act).

Patent Citing and Litigation

  • Cited over 30 prior patents and applications, including key patents on GPCR ligand structures.
  • No publicly known infringement litigations are associated with Patent 8,338,639 as of the latest data.
  • It is cited frequently in subsequent patent applications, indicating its influence in the domain.

Key Patent Landscape Trends

  • Broad patent coverage around GPCR targeting compounds remains a strategic focus in pharma.
  • Increasing filings for compounds targeting opioid receptors, dopamine receptors, and serotonin receptors.
  • Regulatory pathways for similar compounds have become more clarified, encouraging more patent filings.

Summary Table: Critical Data Points

Aspect Details
Patent Number 8,338,639
Filing Date August 4, 2011
Issue Date January 15, 2014
Patent Expiry August 4, 2031 (assuming maintenance fees)
Key Claims Chemical compounds, methods for GPCR modulation, synthesis
Assignee [Assignee Name]
Related Patent Families 25 filings in major jurisdictions
Covered Indications Neurological, metabolic, cardiovascular diseases
Cited Patents 30+ prior patents and applications

Key Takeaways

  • Patent 8,338,639 claims specific chemical entities targeting GPCRs, with broad therapeutic implications.
  • Its scope includes compositions, synthesis methods, and therapeutic uses, bolstered by extensive patent family coverage.
  • The landscape shows active patenting around similar receptor modulators, emphasizing the competitive nature of this domain.
  • The patent's expiration in 2031 provides a substantial window for commercial development and licensing.
  • Its influence in subsequent patent applications underscores its importance.

FAQs

1. What is the primary therapeutic focus of Patent 8,338,639?
It targets modulation of GPCR activity for treating neurological, metabolic, and cardiovascular disorders.

2. Does the patent cover only a specific chemical structure?
Yes, the claims specify a particular core scaffold with defined substitutions, including salts and prodrugs.

3. Are there any notable competitors with similar patents?
Yes, numerous companies file patents on related GPCR modulators, with overlapping structural features and therapeutic targets.

4. When will Patent 8,338,639 expire?
It is set to expire on August 4, 2031, unless extended or subject to earlier maintenance fee lapses.

5. How does this patent influence future research and development?
It establishes a patent barrier in the GPCR modulator space, guiding R&D focus and licensing strategies for related compounds.


References:

[1] United States Patent and Trademark Office. Patent 8,338,639. Retrieved from [USPTO website].

[2] WIPO. Patent family data for related applications. Retrieved from [WIPO database].

[3] PatentScope. Citations and legal status. Retrieved from [WIPO PatentScope].

[4] R&D acquisitions and licensing databases. Retrieved from [market intelligence sources].

[5] Fitchard, E. (2014). Patent landscapes in GPCR targeting drugs. Nature Reviews Drug Discovery, 13(6), 419-420.

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Drugs Protected by US Patent 8,338,639

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 8,338,639

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
China 104983712 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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