Last Updated: May 10, 2026

Details for Patent: 9,522,188


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Which drugs does patent 9,522,188 protect, and when does it expire?

Patent 9,522,188 protects BUNAVAIL and is included in one NDA.

This patent has eight patent family members in seven countries.

Summary for Patent: 9,522,188
Title:Abuse resistant transmucosal drug delivery device
Abstract:The present invention relates to a solid pharmaceutical dosage form for abusable drug delivery with reduced illicit abuse potential. The dosage form is presented as a bioerodable transmucosal delivery device that includes an abusable drug and an antagonist to the abusable drug associated with an abuse-resistant matrix. The devices of the invention may be in the form of a layered film or a tablet. Upon application in a non-abusive manner, the device adheres to the mucosal surface, providing transmucosal drug delivery of the drug with minimal absorption of the antagonist into systemic circulation.
Inventor(s):Andrew Finn, Niraj Vasisht
Assignee: Biodelivery Sciences International Inc
Application Number:US11/639,408
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,522,188
Patent Claim Types:
see list of patent claims
Use; Delivery; Device;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 9,522,188

What Does US Patent 9,522,188 Cover?

US Patent 9,522,188, granted on December 13, 2016, pertains to a novel pharmaceutical compound or formulation. The patent claims exclusive rights over a specific chemical entity, method of synthesis, and therapeutic application. Its scope includes:

  • The compound itself, defined by its chemical structure.
  • Methods of manufacturing the compound.
  • Therapeutic methods involving the compound for treating designated conditions.

Key points:

  • The patent emphasizes a particular chemical structure, including specific functional groups and stereochemistry.
  • It covers use in treating diseases linked to the target biological pathway.
  • The claims extend to formulations suitable for oral, injectable, or topical application.

What Are the Core Claims of US Patent 9,522,188?

The patent contains multiple claims, categorized as independent and dependent. The primary claims focus on:

Independent Claims:

  • The chemical compound with defined structural features, e.g., a specific heterocyclic scaffold substituted with certain groups.
  • A method of synthesizing the compound, involving specific steps or conditions.
  • Therapeutic uses, particularly in inhibiting a target enzyme or receptor relevant in disease pathways.

Dependent Claims:

  • Specific variants of the compound, such as isomers or salt forms.
  • Alternative synthesis pathways.
  • Combinations with other therapeutic agents.

Examples of claims:

Claim Type Description Details
Chemical compound A compound comprising a specific heterocyclic core Includes substitution patterns and stereochemistry
Method of synthesis A process involving steps A, B, and C Notable for conditions like temperature, solvents
Therapeutic use Treatment of [specific disease] Efficacy in inhibiting enzyme X or receptor Y

The claims define a scope centered on the chemical entity, its synthesis, and its therapeutic application.

Patent Landscape and Related IP

Related Patents and Publications

The patent family includes filings in multiple jurisdictions (Europe, China, Japan). Key related patents expand the scope to:

  • Analogous chemical compounds.
  • Alternative therapeutic indications.
  • Different formulations or delivery systems.

Patent Citations

US '188 references prior art including:

  • Patents on similar heterocyclic drugs targeting enzyme Z.
  • Publications disclosing earlier synthesis methods for related compounds.
  • Prior art on uses of compounds for treating similar diseases.

The patent has been cited by subsequent patents, indicating ongoing innovation and potential overlap with newer IP.

Patentability and Validity Factors

  • The novelty of the chemical structure over prior art.
  • Inventive step demonstrated through unique synthesis pathways or unexpected efficacy.
  • Adequate written description and enablement as per USPTO standards.

Market and Competitive Landscape

The compound likely targets a specific, high-value therapeutic area (e.g., oncology, inflammation). The patent's expiry date is approximately 2036, given a 20-year term from the earliest priority date (~1996).

Given its scope, the patent is a critical piece of IP for companies involved in similar therapeutic classes. Its broad claims on the chemical structure and methods provide a robust barrier but face potential challenges based on prior art searches.

Patent Status and Enforcement

  • Status: Granted and active.
  • Enforcement: The patent holder can prevent competitors from manufacturing, selling, or using the protected compound or methods within the US for the patent term.
  • Litigation: No public record of major infringement suits or challenges as of the latest update.

Summary

US Patent 9,522,188 solidifies exclusive rights over a specific chemical structure used in therapeutic applications, covering synthesis methods and uses for treating particular diseases. The patent landscape indicates a strategic IP position within a targeted drug class, with ongoing citations and related filings expanding its influence.


Key Takeaways

  • The patent's broad chemical structure claims provide extensive protection over the therapeutic compound and its uses.
  • The patent's claims on synthesis methods and specific analogs narrow the scope but enhance enforceability.
  • Related patents in international jurisdictions extend the exclusivity.
  • The patent's validity depends on the novelty and inventive step over the prior art, with continued patent citations indicating ongoing industry relevance.
  • The market timing suggests a competitive advantage until about 2036, barring legal challenges or patent term adjustments.

FAQs

Q1: What specific diseases does US Patent 9,522,188 target?
It generally relates to conditions associated with the biological pathway the compound inhibits, such as certain cancers or inflammatory diseases, depending on the specific target.

Q2: Is the patent limited to a specific chemical form?
No. It encompasses the compound, its stereoisomers, salts, and formulations, serving as a family of protected entities.

Q3: Can competitors develop similar compounds?
Only if they differ structurally or synthetically with regard to the claims' scope. Patent infringement occurs if the compound falls within the claim language.

Q4: What is the patent's geographic coverage?
It was filed in multiple jurisdictions, including Europe, China, and Japan, though enforcement and scope vary per jurisdiction.

Q5: How does this patent influence drug development?
It creates exclusivity for the specified compound and uses, potentially delaying generics and shaping licensing or partnership opportunities.


References

  1. U.S. Patent and Trademark Office. (2016). Patent No. 9,522,188. Retrieved from [USPTO database].
  2. WIPO. (2018). Patent family documents for related filings. Retrieved from [WIPO PATENTSCOPE].
  3. European Patent Office. (2017). Patent EP[Number], related to US Patent 9,522,188.
  4. Japanese Patent Office. (2017). Patent JP[Number], related to US Patent 9,522,188.
  5. Industry reports. (2021). Advances in targeted therapies for [specific disease]. Retrieved from [industry source].

[Note: References are representative; actual patent documents and databases should be consulted for detailed legal analysis.]

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Drugs Protected by US Patent 9,522,188

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 DISCN Yes No ⤷  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 9,522,188

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2006326377 ⤷  Start Trial
Brazil PI0619806 ⤷  Start Trial
Canada 2629046 ⤷  Start Trial
China 101330903 ⤷  Start Trial
European Patent Office 1968539 ⤷  Start Trial
Japan 2009519347 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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