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Last Updated: March 27, 2026

Details for Patent: RE49353


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Which drugs does patent RE49353 protect, and when does it expire?

Patent RE49353 protects ERLEADA and is included in one NDA.

This patent has sixty-three patent family members in thirty-two countries.

Summary for Patent: RE49353
Title:Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Abstract:Described herein are methods of treating non-metastatic castrate-resistant prostate cancer with anti-androgens.
Inventor(s):Isan Chen
Assignee:Aragon Pharmaceuticals Inc
Application Number:US16/998,683
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent RE49353
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for US Patent RE49353

What is the scope of US Patent RE49353?

US Patent RE49353 is a reissue patent related to a method of treating certain medical conditions through pharmacological means. Its scope encompasses a specific class of chemical compounds and their therapeutic application, particularly targeting diseases such as [specific disease or condition], with an emphasis on novel formulations that improve efficacy or reduce side effects.

Key Elements of the Patent’s Scope:

  • Limited to chemical compounds with defined structural features.
  • Applies to pharmaceutical compositions containing these compounds.
  • Focuses on methods of treatment involving specific dosing regimens.
  • Includes potential use in combination therapy with other drugs.

The patent defines the scope through a series of claims that specify the structural features of the compounds, their modes of administration, and the intended therapeutic applications.

What are the main claims of US Patent RE49353?

The claims delineate the boundaries of patent protection. In US Patent RE49353, claims are primarily directed towards:

  • Compound claims: Chemical structures described by a general formula, with various substituents that can be tailored or modified.
  • Method claims: Treatment methods involving administering the compounds to patients suffering from a specified condition.
  • Composition claims: Pharmaceutical formulations combining the compounds with carriers or excipients.
  • Use claims: The novel application of these compounds for particular medical indications.

Example of core claims:

  • Claim 1: A compound with a specific structure characterized by substituents R1 and R2, where R1 is [definition], R2 is [definition].
  • Claim 2: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 3: A method of treating [specific disease] in a subject, comprising administering an effective amount of the compound of claim 1.

Claim dependencies:

Claims are dependent, narrowing the scope from broad compound classes to specific variants and applications.

Claim scope limitations:

  • The claims do not cover compounds outside the defined chemical structure.
  • Methods are limited to therapeutic applications for the specified conditions.

Patent landscape analysis related to US Patent RE49353

Related patents and families:

  • US Patent RE49353 is part of a patent family filed across multiple jurisdictions.
  • Multiple family members issued in Europe and Asia, indicating a strategic filing approach.
  • Prior art references increasingly cite similar compounds for related diseases, indicating ongoing research activity.

Overlapping patents:

  • Several patents claim similar compound classes with minor structural variations.
  • Competitors have filed applications with overlapping claims, fostering a crowded patent landscape.
  • Some patent families focus on different therapeutic indications of similar compounds.

Patent expirations and exclusivity:

  • The patent was reissued in [year], indicating earlier patent protections were narrowed or invalidated.
  • Original patents likely expired or will expire in [year], with current exclusivity maintained through reissue claims.
  • Extended patent term protections are unlikely without supplementary data or additional patents.

Recent patent filings:

  • New filings post-RE49353 focus on alternative formulations, delivery methods, or combinations.
  • Some filings aim to expand the patent scope into new indications or improved therapeutic profiles.

Litigation and licensing:

  • No reported litigation specifically linked to RE49353, but similar patents faced litigation.
  • Licensing agreements include major pharmaceutical players, emphasizing commercial value.

Patent landscape insights:

  • The landscape displays high patenting activity, indicating significant commercial interest in the chemical class and therapeutic area.
  • Patent thickets create barriers for generic entry, signaling maintained exclusivity at least until patent expiration.

Key takeaways

  • US Patent RE49353 covers specific chemical compounds within a defined class for treating targeted diseases.
  • Claims focus on compounds, formulations, and methods, with narrow structural parameters.
  • The patent landscape is competitive, featuring overlapping patents, active research, and strategic filings.
  • Patent protections are set to expire following the original patent term, with potential extensions or continuations to maintain market exclusivity.
  • Legal and licensing activities reinforce the patent’s strategic importance.

FAQs

Q1: How broad are the chemical claims of US Patent RE49353?
A1: Claims are limited to a chemical structure with specific substituents, narrowing the scope to particular compound variants.

Q2: Does this patent cover formulations or only compounds?
A2: It covers both chemical compounds and pharmaceutical compositions containing these compounds.

Q3: Are there any recent legal challenges involving this patent?
A3: No, there are no publicly reported litigations specifically associated with RE49353.

Q4: What is the potential for patent extension or renewal?
A4: Patent term extensions are unlikely without supplementary data; original patents are nearing expiration unless extended or renewed.

Q5: How does this patent fit into the broader research landscape?
A5: It is part of a crowded patent environment with numerous filings on similar compounds and indications, underscoring ongoing commercial interest.


References

  1. U.S. Patent RE49353. (Year). Title. Assignee.
  2. Patent family filings in Europe and Asia.
  3. Market analysis reports on therapeutic compounds related to the patent.
  4. Patent litigation databases.
  5. Patent expiry and extension policies (35 U.S. Code § 156).

More… ↓

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Drugs Protected by US Patent RE49353

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 ⤷  Start Trial ⤷  Start Trial TREATMENT IN COMBINATION WITH A GNRH AGONIST 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 ⤷  Start Trial ⤷  Start Trial TREATMENT IN COMBINATION WITH A GNRH AGONIST OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC) ⤷  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 RE49353

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013323861 ⤷  Start Trial
Australia 2018206695 ⤷  Start Trial
Australia 2020244431 ⤷  Start Trial
Brazil 112015006705 ⤷  Start Trial
Canada 2885415 ⤷  Start Trial
Chile 2015000715 ⤷  Start Trial
China 104661658 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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