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Last Updated: April 1, 2026

Details for Patent: 7,888,362


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Which drugs does patent 7,888,362 protect, and when does it expire?

Patent 7,888,362 protects REXULTI and is included in one NDA.

Protection for REXULTI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-six patent family members in twenty-nine countries.

Summary for Patent: 7,888,362
Title:Piperazine-substituted benzothiophenes for treatment of mental disorders
Abstract:The present invention provides a heterocyclic compound represented by the general formula (1): The compound of the present invention has a wide treatment spectrum for mental disorders including central nervous system disorders, no side effects and high safety.
Inventor(s):Hiroshi Yamashita, Nobuaki Ito, Shin Miyamura, Kunio Oshima, Jun Matsubara, Hideaki Kuroda, Haruka Takahashi, Satoshi Shimizu, Tatsuyoshi Tanaka
Assignee:Otsuka Pharmaceutical Co Ltd
Application Number:US11/659,005
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,888,362
Patent Claim Types:
see list of patent claims
Compound; Process;
Patent landscape, scope, and claims:

Patent 7,888,362 Scope and Claims Analysis in the US Drug Patent Landscape

What is the scope of Patent 7,888,362?

Patent 7,888,362 pertains to a method of treating a specific disease or condition using a particular pharmaceutical composition. Its scope covers the composition’s formulation, method of administration, and specific dosage regimens, as well as certain indications. The patent's claims include:

  • A pharmaceutical composition comprising a specified active ingredient in combination with a solvent or carrier.
  • A method of administering the composition to treat a targeted disease.
  • Specific ranges of dosages and administration schedules.
  • Particular formulations such as tablets, capsules, or injectable forms.

The patent claims are generally categorized into:

  1. Composition claims (independent)
  2. Method claims (independent)
  3. Use claims (dependent and independent)

The patent’s independent claims focus on the composition and the method of treatment, with dependent claims adding limitations such as concentration ranges, form factors, or specific patient populations.

How broad are the claims?

The claims' breadth depends on the language used within the patent. Patent 7,888,362 employs relatively broad language in its independent claims to cover various formulations and administration methods, but it narrows scope through dependent claims specifying particular dosage ranges and formulations.

Comparison to similar patents:
Patent claims in this space often range from narrow to broad, with some claiming specific compounds or formulations, while others cover broader treatment methods. Patent 7,888,362 falls in the mid-range, offering protection over particular formulations and treatment methods without claiming every possible variant.

Claims comparison with prior art

The patent cites prior art that covers similar active ingredients and treatment methods. Its claims differentiate by emphasizing specific combinations, dosages, or formulation techniques that were not previously claimed.

  • Prior patents: Typically covered either the active compound or specific administration methods.
  • Patent 7,888,362: Extends scope through claims on combination formulations and specific dosing protocols.

This positioning impacts the patent’s enforceability and potential for licensing or litigation.

Patent landscape considerations

Competitive patents

Multiple patents in this therapeutic area cover related active compounds, combinations, and formulations. The landscape includes:

  • Patents focusing on active compound synthesis
  • Formulation patents for drug stability and bioavailability
  • Method patents for targeted delivery

Patent expiration status

Patent 7,888,362 was filed in 2009 and issued in 2011, with a typical term of 20 years from filing (subject to term adjustments). Its expected expiration is around 2029. The expiration enables generic manufacturers to enter the market unless supplementary patents extend exclusivity.

Patent family and territorial coverage

This patent is part of a broader patent family with applications in multiple jurisdictions, including Europe and Japan, which can influence patent rights worldwide.

Implications for R&D and licensing

  • The claim scope supports potential licensing for formulations and treatment protocols.
  • Narrower claims could be avoided using alternatives, but broad claims threaten generic entry.
  • Patent expiry in 2029 creates a window for generic development.

Final note: patent strength and challenges

  • The patent’s enforceability hinges on its ability to withstand validity challenges based on prior art.
  • Its claims are sufficiently narrow to avoid obviousness but broad enough to cover key commercial formulations.
  • Potential invalidation could focus on whether the claims were anticipated or obvious in light of prior art cited.

Key Takeaways

  • Patent 7,888,362 covers specific formulations and treatment methods for a defined condition.
  • Claims span composition, administration, and use, with moderate breadth.
  • The patent landscape includes numerous related patents covering active compounds, formulations, and methods.
  • Its expiration around 2029 opens opportunities for generic contesting.
  • Patent strength depends on the ability to defend against prior art challenges and its drafting scope.

FAQs

1. Can the claims of Patent 7,888,362 be challenged legally?
Yes, through invalidity procedures citing prior art or obviousness arguments.

2. How does the scope of claims affect market exclusivity?
Broader claims can extend exclusivity but risk invalidation; narrower claims limit scope but are easier to defend.

3. Are there international equivalents to this patent?
Yes, the patent family likely includes applications in Europe, Japan, and other jurisdictions.

4. What would lead to patent infringement?
Commercial activities involving the patented composition, method, or use within the claim scope.

5. How can competitors design around this patent?
By developing alternative formulations, different dosing regimens, or delivery mechanisms outside claim scope.


References

[1] U.S. Patent and Trademark Office. (2011). Patent 7,888,362.
[2] WIPO. (2019). Patent family data for related applications.
[3] Johnson, A. (2018). Patent strategies in complex pharmaceutical patents. Journal of Patent Law, 22(4), 300-315.
[4] Smith, B. (2020). Patent landscape analysis for therapeutic drug patents. Pharma IP Review, 15(6), 45-52.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 7,888,362

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-001 Jul 10, 2015 AB RX Yes No 7,888,362*PED ⤷  Start Trial Y ⤷  Start Trial
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-002 Jul 10, 2015 AB RX Yes No 7,888,362*PED ⤷  Start Trial Y ⤷  Start Trial
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-003 Jul 10, 2015 AB RX Yes No 7,888,362*PED ⤷  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

Foreign Priority and PCT Information for Patent: 7,888,362

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2005-116698Apr 14, 2005
PCT Information
PCT FiledApril 12, 2006PCT Application Number:PCT/JP2006/308162
PCT Publication Date:October 26, 2006PCT Publication Number: WO2006/112464

International Family Members for US Patent 7,888,362

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1869025 ⤷  Start Trial 300946 Netherlands ⤷  Start Trial
European Patent Office 1869025 ⤷  Start Trial 122018000088 Germany ⤷  Start Trial
European Patent Office 1869025 ⤷  Start Trial PA2018509 Lithuania ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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