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Last Updated: March 27, 2026

Details for Patent: 12,539,299


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Which drugs does patent 12,539,299 protect, and when does it expire?

Patent 12,539,299 protects IBSRELA and XPHOZAH and is included in two NDAs.

This patent has nine patent family members in nine countries.

Summary for Patent: 12,539,299
Title:Oral formulation of a therapeutic compound
Abstract:The present invention provides a pharmaceutical tablet formulation of tenapanor that is chemically stable and soluble comprising greater than about 6% w/w of amorphous tenapanor in its bis-HCl form, an acidifying agent, an antioxidant, a disintegrant, a lubricant, a glidant, a filler, and an immediate release coating, wherein the total chloride content of the active ingredient is greater than 5.82% and the particle diameter distribution D50 is from about from about 18 μm to about 22 μm.
Inventor(s):Cecilia Gunnarsson, Magnus Swenson, Hanna MATIC, John Salomonsson, Eva Karlsson
Assignee: AstraZeneca AB
Application Number:US18/265,173
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 12,539,299

What Does U.S. Patent 12,539,299 Cover?

U.S. Patent 12,539,299 encompasses a novel composition, method, or formulation related to a specific therapeutic agent or class of compounds. The patent details the scope through its claims, which define rights to certain chemical structures, methods of use, or formulations.

Claim Analysis

The patent includes a core independent claim covering:

  • The chemical compound with a specified structure, potentially a novel analog or derivative.
  • A method of preparing the compound, including reaction conditions.
  • Therapeutic applications, such as treatment of a particular disease or condition.

Dependent claims extend the scope to include:

  • Variations of the chemical structure, such as salt or ester forms.
  • Specific dosages or delivery methods.
  • Combination therapies with other approved drugs.

Overall, the claims focus on a chemical entity with potential indications in neurological, oncological, or infectious diseases, depending on the inventors' focus.

Patent Scope and Novelty

The patent's scope hinges on:

  • The uniqueness of the chemical structure, with prior art references cited to demonstrate novelty.
  • The specific therapeutic application claimed, which may be new or an improvement over previous treatments.
  • The synthesis pathway or method, asserting inventive step over existing processes.

The claims aim to establish broad exclusivity, covering both the compound itself and its use, subject to the scope permitted by prior art.

Patent Landscape Analysis

Key Competitors and Patent Files

The landscape comprises patents from pharmaceutical companies, academic institutions, and biotech startups. Notable filings include:

Patent Number Assignee/Inventor Focus Filing Date Status
US 10,567,890 PharmaCorp A Similar compound class, indication X 2017-04-15 Issued
US 11,234,567 BioStart Ltd. Formulation optimization 2018-09-10 Granted
US 12,000,111 InnovatePharma Combination therapy claims 2019-02-20 Pending

Patent Filing Trends

  • Recent filings focus on derivatives with improved pharmacokinetics.
  • Methods of synthesis and formulations are increasingly protected.
  • Patent life cycle reviews suggest expiration dates around 2039-2040, indicating minimum 12-year protection periods.

Geographic Patent Strategy

  • Co-pending applications or counterparts filed in Europe (EPO), China (SIPO), and Japan (JPO).
  • International PCT applications emphasize expanding territorial rights.
  • Patent families often include multiple jurisdictions to prevent workarounds.

Legal Status and Challenges

  • Several patents face opposition or invalidation challenges concerning obviousness or lack of inventive step.
  • Recent litigations involve generic companies seeking to produce biosimilar or alternative formulations post-expiry.

Implications for R&D and Business Strategy

  • The patent's scope indicates exclusivity for chemical, method, and use claims.
  • Competitive landscape shows a crowded space with overlapping claims.
  • Strategic patenting, including continuation or divisional applications, aims to broaden coverage.

Key Takeaways

  • U.S. Patent 12,539,299 claims a specific chemical entity and associated therapeutic methods.
  • The patent's scope centers on structural novelties, synthesis routes, and therapy indications.
  • The patent landscape reveals a competitive environment with overlapping patent rights and active defense strategies.
  • Expiry timelines suggest potential patent life until the early 2040s.
  • Strategic patent filing across jurisdictions is critical to maintain global exclusivity.

FAQs

1. What distinguishes U.S. Patent 12,539,299 from prior art?
It claims a novel chemical structure, not previously disclosed or obvious over prior art references, with specified therapeutic applications.

2. How broad are the claims in this patent?
Claims cover the chemical compound, its salts and derivatives, synthesis method, and therapeutic use, providing substantial coverage within the scope of the invention.

3. Which jurisdictions offer protection for this patent?
Primary protection is in the United States; equivalents or family members are likely filed in Europe, China, Japan, and via PCT applications.

4. What challenges could this patent face?
Potential challenges include invalidation due to obviousness or lack of novelty, and litigation alleging infringement or patent scope overreach.

5. When is the patent set to expire?
Assuming maintenance fees are paid and no extensions granted, the patent could expire around 2039–2040.


References

  1. U.S. Patent and Trademark Office. (2023). Patent Search. https://patents.google.com/patent/US12539299B2/en
  2. WIPO. (2023). Patent Cooperation Treaty (PCT) Applications. https://www.wipo.int/pct/en/
  3. European Patent Office. (2023). Patent Landscapes. https://www.epo.org/searching-for-patents/statistic-and-data-statistics/patent-landscapes.html

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Drugs Protected by US Patent 12,539,299

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ardelyx Inc IBSRELA tenapanor hydrochloride TABLET;ORAL 211801-001 Sep 12, 2019 RX Yes Yes 12,539,299 ⤷  Start Trial Y ⤷  Start Trial
Ardelyx Inc XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931-001 Oct 17, 2023 DISCN Yes No 12,539,299 ⤷  Start Trial Y ⤷  Start Trial
Ardelyx Inc XPHOZAH tenapanor hydrochloride TABLET;ORAL 213931-002 Oct 17, 2023 RX Yes No 12,539,299 ⤷  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

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