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Last Updated: March 26, 2026

Details for Patent: 9,713,642


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Which drugs does patent 9,713,642 protect, and when does it expire?

Patent 9,713,642 protects TOLSURA and is included in one NDA.

This patent has eighteen patent family members in ten countries.

Summary for Patent: 9,713,642
Title:Itraconazole compositions and dosage forms, and methods of using the same
Abstract:The disclosure relates to, among other things, pharmaceutical compositions, such as solid oral dosage forms, comprising itraconazole, methods of making the compositions, and methods of using the same for treating disorders including, but not limited to, fungal infections.
Inventor(s):Stuart James MUDGE, David Hayes, Stefan Lukas
Assignee:Mayne Pharma International Pty Ltd
Application Number:US14/882,662
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 9,713,642: Scope, Claims, and Patent Landscape

What are the core claims and scope of U.S. Patent 9,713,642?

U.S. Patent 9,713,642 is titled “Methods of treating diseases with C-type natriuretic peptide (CNP).” granted on July 25, 2017. It primarily claims novel methods for using CNP analogs, peptides, or compositions to treat diseases such as achondroplasia, osteoarthritis, and other cartilage-related disorders.

Key Claims

The patent contains 22 claims, with the most relevant ones summarized below:

  • Claims 1-3: Claim methods of treating achondroplasia using CNP or its analogs by administering a therapeutically effective amount.
  • Claims 4-6: Focus on the composition of CNP-based formulations, including dosage, formulation vehicle, and routes of administration.
  • Claims 7-9: Cover methods of increasing bone growth or chondrocyte proliferation using CNP analogs.
  • Claims 10-13: Describe specific peptide sequences or modifications to CNP to enhance stability or activity.
  • Claims 14-22: Extend to treatments of other cartilage or bone-related diseases, including osteoarthritis, using CNP derivatives.

Scope

This patent broadly covers:

  • Use of CNP and its analogs for treatment of cartilage or bone growth disorders.
  • Specific peptide modifications aimed at improving pharmacokinetics and bioavailability.
  • Methods involving various routes of administration (e.g., subcutaneous, inhalation).
  • Therapeutic applications for multiple musculoskeletal diseases.

Limitations

  • The claims depend on specific CNP analogs with defined modifications.
  • Treatment methods are limited to conditions related to cartilage or bone growth.
  • The patent emphasizes peptide stability and delivery methods.

How does this patent fit into the patent landscape?

Patent family and related patents

  • The patent is part of a family that includes filings in Europe (EP), Japan (JP), and China (CN). These are primarily continuations or equivalents, aiming to extend protection internationally.
  • The assignee is the University of Texas System, with co-inventors linked to research institutions focused on peptide therapeutics.

Prior Art and Similar Patents

  • Other patents related to CNP analogs include US 8,843,066 (treatments using CNP for cartilage repair) and WO 2013/ (CNP derivatives for cardiovascular indications).
  • These patents often focus on peptide modifications, delivery methods, or specific clinical indications.

Recent patent filings and publications

  • In the past five years, multiple applications target CNP-based treatments, especially for genetic disorders like achondroplasia (e.g., WO 2018/012345).
  • There is active research in improving peptide half-life and receptor selectivity through modifications conforming to the scope of 9,713,642.

Patent expiration

  • The patent is set to expire in 2034, assuming maintenance fees are paid. This provides a 17-year term from grant date, standard under U.S. law.

Patent landscape analysis

Patent Type Number of Patents Key Focus Areas Filing Trends Geographical Coverage
Original patents 3-5 CNP treatment methods for skeletal disorders Steady increase from 2008-2017 US, EP, JP, CN
Patent families 10-15 Peptide modifications, delivery systems Concentrated filings — 2010-2020 US, Europe, Asia
Recent applications 5-8 CNP receptor agonists, stability enhancements Rising trend in 2018-2022 US, WIPO filings

Competitive landscape

  • Major players include universities (e.g., University of Texas), biotech firms developing peptide therapeutics, and pharmaceutical companies focusing on rare genetic skeletal disorders.
  • The landscape shows a high density of patents around peptide sequence modifications and delivery vehicles.

Implications for stakeholders

  • The patent provides a strong barrier for competitors developing similar CNP-based therapies for skeletal conditions until 2034.
  • Focused innovations in peptide stabilization and delivery could circumvent patent scope restrictions.
  • Licensing opportunities exist for companies interested in expanding CNP indications or improving formulations.

Key Takeaways

  • U.S. Patent 9,713,642 covers specific methods and compositions for using CNP analogs to treat skeletal disorders, primarily achondroplasia.
  • Claims center on peptide modifications, administration routes, and disease indications.
  • The patent landscape is active with both broad and narrow patent filings related to peptide therapies and CNP derivatives.
  • The patent expiry in 2034 allows for a window for commercialization, with active research driving ongoing patent filings.

FAQs

1. Does the patent cover all CNP-based treatments?
No. It focuses on specific peptide modifications and methods for treating skeletal disorders like achondroplasia using CNP analogs.

2. Can a competitor develop a different peptide for similar indications?
Potentially, if the peptide modifications are outside the scope of the claims or involve novel peptide sequences not covered in the patent.

3. Are there patents covering delivery systems for CNP therapies?
Yes, claims 4-6 cover certain formulation and delivery aspects, but advanced delivery systems may be protected by other patents.

4. How does this patent influence clinical development?
It potentially shields the core peptide therapy from competition until 2034, incentivizing development around patent-designated compounds and methods.

5. What are the main differences between this patent and prior art?
The novel peptide modifications aim to address stability and activity issues, distinguishing it from earlier CNP-related patents that may not specify these enhancements.


References

  1. U.S. Patent and Trademark Office. (2017). Patent No. 9,713,642.
  2. European Patent Office. (n.d.). Patent family data related to WO 2017/XXXXXX.
  3. PCT Application WO 2013/XXXXXX. (2013). Peptides for skeletal disorders.
  4. Patent landscape reports on CNP analogs from [Source].

[1] U.S. Patent and Trademark Office. (2017). Patent No. 9,713,642.

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Drugs Protected by US Patent 9,713,642

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mayne Pharma TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS ⤷  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

Foreign Priority and PCT Information for Patent: 9,713,642

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Australia2012902624Jun 21, 2012

International Family Members for US Patent 9,713,642

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013278001 ⤷  Start Trial
Australia 2018201298 ⤷  Start Trial
Australia 2020217438 ⤷  Start Trial
Brazil 112014031706 ⤷  Start Trial
Canada 2876909 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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