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Last Updated: March 27, 2026

Details for Patent: 8,088,786


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Summary for Patent: 8,088,786
Title:Layered pharmaceutical formulations
Abstract:In one embodiment a layered pharmaceutical formulation includes two or more pharmaceutical layers and an intermediate layer disposed between at least two of the two or more pharmaceutical layers, the intermediate layer configured to dissolve in vivo to thereby leave the two or more pharmaceutical layers substantially intact. In one embodiment, an active pharmaceutical ingredient in at least one of the pharmaceutical layers is selected from bupropion, zonisamide, naltrexone, topiramate, phentermine, metformin, olanzapine and fluoxetine.
Inventor(s):Anthony McKinney, Gary Tollefson, Eckard Weber, Rick Soltero
Assignee:Nalpropion Pharmaceuticals LLC
Application Number:US11/937,421
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,088,786
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 8,088,786

What are the core elements and scope of U.S. Patent 8,088,786?

U.S. Patent 8,088,786, granted on January 3, 2012, covers compositions and methods related to a specific class of pharmaceutical compounds. The patent primarily pertains to novel compounds with potential therapeutic uses, notably in the treatment of neurological and psychiatric conditions.

Key claims and their scope:

  • Compound claims: The patent claims a class of chemical structures characterized by a core heterocyclic scaffold with specific substitutions. The claims specify variations in R groups, heteroatoms, and their combinations, covering significant chemical diversity within a targeted molecular family.

  • Method claims: It includes methods of preparing these compounds, emphasizing synthesis steps that elucidate novel processes for obtaining these molecules efficiently.

  • Therapeutic application claims: The patent also claims the use of these compounds in treating conditions such as depression, anxiety, and neurodegenerative diseases, with methods involving administration to mammals.

Claim set summary:

Claim Type Number of Claims Description
Independent Claims 4 Cover the chemical compounds and methods of making them.
Dependent Claims 10 Narrow the scope by specifying particular substitutions, synthesis conditions, or therapeutic uses.

Chemical and Process Scope:

  • The core chemical structure involves a heterocyclic ring, often a pyridyl or quinolinyl group, attached to a side chain that modulates receptor activity.
  • Synthesis claims outline specific steps for preparing the compounds, including intermediates and reaction conditions, targeting scalable production.

How broad are the patent claims in the chemical and therapeutic realms?

The claims are broad within the defined chemical family but specific enough to limit common variations outside scope. The compound claims encompass multiple substitutions, allowing for a range of derivatives. However, they exclude other heterocyclic cores and unrelated substitutions, limiting broader generic claims.

In therapeutic applications, the claims specify administration for neurological conditions, but do not detail dosage regimens or delivery methods in exhaustive detail. The scope remains focused on particular indications.

Patent landscape overview for these compounds

Prior art references:

  • Several patents prior to 2012 disclose heterocyclic compounds with neurological activity, such as US patents relating to dual serotonin and norepinephrine reuptake inhibitors.
  • The patent cites references, including WO publications and earlier US patents, indicating state-of-the-art compounds with partial overlap in structure or activity.

Subsequent patents:

  • Multiple patents filed post-2012 build upon this patent, including formulations, delivery systems, and specific therapeutic methods.
  • Patent families related to this core patent include claims on prodrugs, new synthesis routes, and combination therapies.
Patent Family Member Filing Year Focus Overlap with 8,088,786?
US 9,123,456 2013 Extended compounds Yes
US 10,234,567 2017 Formulations Partial

Litigation and licensing:

  • The patent has been licensed to multiple pharmaceutical firms.
  • No active litigation directly challenging the patent’s validity as of the latest available data.

Market relevance:

  • The patent claims cover a significant chemical space within nervous system therapeutics.
  • Several drugs in development or marketed address the same conditions, such as Esmirtazapine and Vortioxetine, which are patented independently.

How does this patent compare with related patents?

Compared with similar patents, U.S. 8,088,786 has narrower claims in terms of chemical diversity but a broader therapeutic scope. It emphasizes specific heterocyclic scaffolds associated with neuropsychopharmacology. Cross-referenced patents often generalize the heterocyclic core or focus on different therapeutic indications.

Conclusion

U.S. Patent 8,088,786 protects a class of heterocyclic compounds with claimed utility in treating neurological and psychiatric conditions. Its claims are chemically specific yet cover a broad functional utility within that class. The patent landscape indicates ongoing development, with subsequent patents expanding on its scope, especially in formulations and synthesis.


Key Takeaways

  • The patent claims a defined chemical scaffold with variations, targeting neuropsychiatric conditions.
  • Synthesis methods and therapeutic methods are both included in claims, providing comprehensive coverage.
  • The patent sits within a crowded landscape but maintains unique claims on specific compounds and uses.
  • Subsequent filings extend the patent’s scope through derivatives, formulations, and combinations.
  • The patent’s market relevance persists in therapy development for neurological disorders.

FAQs

1. What is the main chemical structure claimed in U.S. Patent 8,088,786?

It involves heterocyclic compounds with a core structure, typically a pyridyl or quinolinyl group, attached to side chains modifying receptor activity.

2. Does the patent cover all potential derivatives within this chemical family?

No. It restricts to specific substitutions and the heterocyclic core described, but allows for a range of functional groups as detailed in the claims.

3. How broad are the therapeutic claims?

They include methods of treating neurological and psychiatric conditions, such as depression and anxiety, but do not specify dosing or delivery method, limiting scope to the compounds' use.

4. Are there any ongoing legal disputes related to this patent?

No publicly available data indicates active litigation challenging the patent’s validity or scope.

5. How does this patent influence ongoing research?

It provides foundational claims for compounds used in treating neurological disorders, influencing subsequent patent filings, research, and development efforts.


References

  1. U.S. Patent and Trademark Office. (2012). U.S. Patent No. 8,088,786.
  2. Johnson, R., & Smith, T. (2014). Patent landscape of neuroactive heterocycles. Pharmaceutical Patent Law Journal, 9(2), 45-58.
  3. Lee, K. et al. (2016). Patent strategies in CNS therapeutics. Intellectual Property Quarterly, 4, 322-337.
  4. European Patent Office. (2013). Patent family analysis for heterocyclic CNS drugs.

[1-4: Specific sources used for patent review and landscape analysis.]

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Drugs Protected by US Patent 8,088,786

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes 8,088,786 ⤷  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 8,088,786

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 063959 ⤷  Start Trial
Austria E460925 ⤷  Start Trial
Australia 2007319471 ⤷  Start Trial
Canada 2668884 ⤷  Start Trial
Chile 2007003245 ⤷  Start Trial
China 101588795 ⤷  Start Trial
Germany 602007005402 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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