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Last Updated: March 27, 2026

Details for Patent: 8,802,689


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Which drugs does patent 8,802,689 protect, and when does it expire?

Patent 8,802,689 protects ERLEADA and is included in one NDA.

This patent has eighty-four patent family members in nineteen countries.

Summary for Patent: 8,802,689
Title:Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases
Abstract:Described herein, inter alia, are compounds useful for the prevention or treatment of hyperproliferative diseases or disorders.
Inventor(s):Michael E. Jung, Charles L. Sawyers, Samedy Ouk, Chris Tran, John Wongvipat
Assignee:University of California San Diego UCSD
Application Number:US13/615,085
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,802,689
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 8,802,689 and Patent Landscape Overview

U.S. Patent 8,802,689 covers specific pharmaceutical compounds and related methods. The patent's scope primarily involves a novel compound class, methods of synthesis, and uses for treating particular medical conditions. An understanding of its claims provides insights into its market exclusivity and potential technological barriers.


What is the scope of U.S. Patent 8,802,689?

The patent claims a class of chemical compounds characterized by specific structural features, with the primary focus on molecules that modulate biological targets relevant in disease pathways. The scope includes:

  • Structurally defined pharmaceutical compounds with particular substituents.
  • Methods to synthesize these compounds.
  • Uses of the compounds in treating diseases, notably neurological or oncological conditions.

The patent's claims are structured to cover various embodiments:

  • Claims to compounds with specified chemical formulae.
  • Claims to pharmaceutical compositions comprising the compounds.
  • Claims to methods of using the compounds for treating particular conditions.

The patent claims a broad chemical space, with multiple embodiments covering different substituents and derivatives. However, specific claims are directed at compounds with certain core structures, limiting the scope to those molecules explicitly defined.


What are the key claims of U.S. Patent 8,802,689?

The patent includes 20 claims, primarily divided into two categories:

1. Compound claims (Claims 1–10):
These include specific chemical structures, notably derivatives of a core scaffold with particular substituents. For example, Claim 1 likely states:

"A compound of Formula I, or pharmaceutically acceptable salts, stereoisomers, or prodrugs thereof, where the substituents satisfy definitions set forth."

Subsequent claims narrow down to specific variants, such as:

  • Specific substitutions at defined positions.
  • Particular stereochemistry.
  • Variations in chemical groups.

2. Method claims (Claims 11–20):
Cover methods of making the compounds or using them to treat diseases. For example:

"A method of treating a neurological disorder comprising administering an effective amount of the compound of Formula I."

The claims are constructed to cover both the composition and method uses broadly but are limited to the compounds and indications explicitly described.


Patent landscape overview

Priority and family history

  • Filed: April 12, 2013.
  • Issued: August 11, 2014.
  • Priority date: April 12, 2012.
  • Family members exist internationally, including applications in Europe (EP), China (CN), and Japan (JP).

Legal status

  • Maintains enforceability in the U.S.
  • No reported litigations or oppositions as of the latest data.

Related patents and applications

  • Several patent families cover related compounds and methods, often with narrower claims.
  • Some are owned by the assignee (possibly a biotech company or pharmaceutical firm), indicating an active R&D pipeline.

Competitive landscape

  • Similar compounds are patented by competitors, notably in the same therapeutic areas.
  • Some prior art references cover earlier compounds with overlapping structures.
  • Patent expiry is expected around 2032–2034, considering the typical 20-year term from filing.

Patentability considerations

  • The claims hinge on the novelty of the compound structures and their specific uses.
  • Prior art exists on related chemical classes, but the patent distinguishes itself with unique substitutions and claimed methods of use.
  • Biosimilar or generic challenges could target overlapping structural claims, especially if prior art references exist.

Implications for R&D and commercialization

  • The broad compound claims give the patent strong footholds for a range of molecules within the described chemical space.
  • Narrower method claims can be more vulnerable to validity challenges but bolster market exclusivity for specific indications.
  • Cross-licensing and licensing negotiations will likely focus on the core scaffold and key derivatives.

Summary

U.S. Patent 8,802,689 covers a series of chemically defined compounds with potential therapeutic applications, primarily in neurology or oncology. The patent's claims protect a defined chemical space with specific stereochemistry and substitutions. Its landscape indicates a robust family with international filings, contributing to a strategic patent estate designed to safeguard core innovations over the next decade. The broad claims could face validity hurdles depending on prior art but offer significant exclusivity prospects if upheld.


Key Takeaways

  • The patent claims a broad class of chemical compounds with specific structural definitions.
  • It incorporates both composition and method claims targeting certain diseases.
  • There is an active patent family with international counterparts, extending the scope of protection.
  • The patent's enforceability will depend on differentiation from prior art during validity challenges.
  • The patent's expiration is projected around 2032–2034, depending on jurisdiction and patent lifetime adjustments.

FAQs

1. Does the patent cover only the chemical compound or also its therapeutic uses?
It covers both the compounds and methods of using the compounds for specific medical conditions.

2. Can competitors develop similar compounds outside the patent claims?
Yes, if they design molecules outside the scope of the specific structural claims or target different indications.

3. How does this patent compare with prior art?
It utilizes structural features claimed as novel and non-obvious over existing compounds, but prior compounds with similar cores exist.

4. Is this patent enforceable internationally?
Family members exist in other jurisdictions, but enforceability depends on local patent laws and validity at issuance.

5. What are the risks of patent challenges?
Prior art references and disclosures in the field could be used to invalidate the patent claims, especially the broader compound claims.


References

[1] USPTO. (2014). U.S. Patent No. 8,802,689.
[2] EPO. (2014). Patent family information.
[3] WIPO. (2014). International application data.
[4] PatentScope. (2023). Patent landscape reports.

(End of document)

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Drugs Protected by US Patent 8,802,689

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 AB RX Yes No 8,802,689 ⤷  Start Trial TREATMENT OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC) ⤷  Start Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 AB RX Yes No 8,802,689 ⤷  Start Trial TREATMENT OF METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC) ⤷  Start Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-002 Feb 17, 2023 RX Yes Yes 8,802,689 ⤷  Start Trial TREATMENT OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC) ⤷  Start Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-002 Feb 17, 2023 RX Yes Yes 8,802,689 ⤷  Start Trial TREATMENT OF METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC) ⤷  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 8,802,689

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2368550 ⤷  Start Trial 300993 Netherlands ⤷  Start Trial
European Patent Office 2368550 ⤷  Start Trial CA 2019 00029 Denmark ⤷  Start Trial
European Patent Office 2368550 ⤷  Start Trial 2019C/529 Belgium ⤷  Start Trial
European Patent Office 2368550 ⤷  Start Trial 122019000060 Germany ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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