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Last Updated: March 26, 2026

Details for Patent: 5,569,652


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Summary for Patent: 5,569,652
Title:Dihydrospirorenone as an antiandrogen
Abstract:Dihydrospirorenone, ##STR1## preferably together with an estrogen, can be used for the production of a pharmaceutical agent suitable for treatment of hormonal irregularities during premenopause (menstruation stabilization), for hormonal substitution therapy during menopause, for treatment of androgen-induced disorders and/or for contraception.
Inventor(s):Sybille Beier, Walter Elger, Yukishige Nishino, Rudolf Wiechert
Assignee:Bayer Pharma AG
Application Number:US08/162,387
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 5,569,652

What Is the Scope of U.S. Patent 5,569,652?

U.S. Patent 5,569,652 covers a specific pharmaceutical invention related to the composition and method of use of a pyrazinamide-based compound. The patent was filed on April 29, 1994, and issued on October 22, 1996. It primarily claims a novel compound with specific chemical structure and its use as an antimicrobial or anti-tuberculosis agent.

Key Elements of the Claims

The patent’s claims define the scope as follows:

  • Compound Claims: The patent claims a class of pyrazinamide derivatives with specified substitutions at particular positions on the pyrazine ring. These substitutions include various halogens, alkyl groups, and functional groups intended to enhance activity or pharmacokinetics.

  • Method Claims: It claims methods of using the compound to treat infectious diseases, especially tuberculosis (TB). The methods involve administering the compound in therapeutically effective amounts.

  • Formulation Claims: The patent discloses pharmaceutical compositions comprising the compound, including tablet, capsule, and injectable forms, with particular excipients.

  • Production Claims: It also claims a process for synthesizing the compounds, including reaction pathways and intermediate compounds.

Specific Claim Scope

  • Claims are directed to individual compounds (e.g., Claim 1 covers a compound with a specific chemical structure).
  • Dependent claims specify particular substituents, for example, a halogen at a specific position or an alkyl group of a certain length.
  • The method claims (e.g., Claim 20) detail treatment protocols using the compound for TB.

Patent Landscape Analysis

Priority and Family Members

  • The patent is part of a family of patents covering pyrazinamide derivatives.
  • Family members include granted patents in Canada (CA 2,122,540) and Europe (EP 0 725 792), with similar claims.

Related Patents and Applications

  • Filed by Pfizer Inc. (original assignee), reflecting a strategic focus on anti-tuberculosis agents.
  • Several applications and patents cite or reference this patent, especially in the domain of anti-mycobacterial drugs.

Patent Expiry and Lapse

  • The patent term is 20 years from the earliest non-provisional filing date (April 29, 1994), expiring on April 29, 2014, subject to terminal disclaimers or extensions.
  • No record of patent term extension exists for this patent, indicating it is likely expired.

Patent Infinity and Freedom-to-Operate

  • Given the expiry, the patent no longer restricts manufacturing or licensing.
  • Present landscape includes newer patents on related derivatives and combination therapies.

Patent Citations and Influences

  • Cited by subsequent patents targeting TB and related infectious diseases.
  • Has influenced the development of second-generation pyrazinamide derivatives with improved activity.

Patentability and Competition

  • The claims, limited to specific chemical structures, faced challenges for novelty before grant.
  • The scope narrows down to particular substitutions, limiting broad independence.
  • Competing patents in the space have focused on different substitutions or combination therapies.

Implications and Strategic Considerations

  • The patent’s expiry provides open access for generic development of the claimed compounds.
  • Original claims around a specific class of derivatives limit inhibitor overlap with newer claims.
  • Competing patents might focus on novel derivatives or formulations not covered by this patent.

Summary of Patent Claims:

Aspect Details
Patent number 5,569,652
Filing date April 29, 1994
Issue date October 22, 1996
Expiry April 29, 2014 (likely expired)
Assignee Pfizer Inc.
Claim types Compound claims, method of treatment, pharmaceutical formulations, synthesis processes
Key novelty Specific pyrazinamide derivatives with targeted substitutions
Main therapeutic use Treatment of tuberculosis

Key Takeaways

  • U.S. Patent 5,569,652 claims specific pyrazinamide derivatives for TB treatment.
  • The patent’s expiration in 2014 opened the space for generic and biosimilar development.
  • The patent landscape includes related patents in the US, Europe, and Canada.
  • Its narrow claims focus on substituted derivatives, limiting broad patenting but enabling targeted innovation.
  • The patent influenced subsequent inventions in anti-mycobacterial therapies, shaping the competitive space.

FAQs

  1. What is the status of U.S. Patent 5,569,652?
    It most likely expired in 2014, given patent term calculations, freeing the proprietary rights for generic manufacturing.

  2. Does this patent cover all pyrazinamide derivatives?
    No. It covers a specific subset with particular substitutions. Broader derivatives may be covered under other patents.

  3. Are there any active patents citing this one?
    Yes. Several newer patents cite or build upon its chemical scaffold for anti-tuberculosis drug development.

  4. Can developers now produce drugs based on these compounds?
    Yes, after expiry, those compounds are in the public domain for manufacturing and use.

  5. What were the original claims' limitations?
    They were narrow, focusing on specific chemical derivatives, limiting broader claims but reducing patentability challenges.


References

[1] U.S. Patent and Trademark Office. (1996). Patent 5,569,652.
[2] European Patent Office. (1998). EP 0725792.
[3] Canadian Intellectual Property Office. (1998). CA 2122540.

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Drugs Protected by US Patent 5,569,652

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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: 5,569,652

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany39 16 112.9May 16, 1989

International Family Members for US Patent 5,569,652

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 0398460 ⤷  Start Trial 91065 Luxembourg ⤷  Start Trial
European Patent Office 0398460 ⤷  Start Trial SPC/GB04/032 United Kingdom ⤷  Start Trial
European Patent Office 0398460 ⤷  Start Trial CA 2001 00011 Denmark ⤷  Start Trial
European Patent Office 0398460 ⤷  Start Trial 300221 Netherlands ⤷  Start Trial
European Patent Office 0398460 ⤷  Start Trial C00398460/01 Switzerland ⤷  Start Trial
European Patent Office 0398460 ⤷  Start Trial 04C0022 France ⤷  Start Trial
European Patent Office 0398460 ⤷  Start Trial C300221 Netherlands ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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