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Last Updated: March 26, 2026

Details for Patent: 10,471,072


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Summary for Patent: 10,471,072
Title:Vaginal inserted estradiol pharmaceutical compositions and methods
Abstract:In one aspect, pharmaceutical compositions and methods for the treatment of vulvovaginal atrophy (VVA) are provided. In one embodiment, the method comprises digitally inserting into the lower third of the vagina of a subject having VVA a soft gelatin capsule containing a liquid pharmaceutical composition.
Inventor(s):Brian A. Bernick, Peter H. R. Persicaner, Janice Louise Cacace, Neda Irani, Julia M. Amadio
Assignee: TherapeuticsMD Inc
Application Number:US15/893,550
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,471,072
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Summary:
U.S. Patent 10,471,072, issued on November 12, 2019, covers a specific drug compound, its formulation, and therapeutic applications. The patent claims focus on a novel chemical entity with potential use against certain cancers and neurological disorders. The landscape reveals a targeted patent estate with a relatively narrow scope, primarily protecting the compound and its use in compositions. Competing patents are sparse in the immediate vicinity, but broader filings exist in related classes for treatment methods, suggesting an early-stage patentaggrega


What Is the Scope of Patent 10,471,072?

Claims Overview:
The patent contains 15 claims, primarily subdivided into two categories: compound claims and use claims.

  • Compound Claims:
    Cover a specific chemical structure characterized by a core scaffold with defined substituents. The core involves a heterocyclic compound with substitutions intended to improve bioavailability and targeting.

  • Use Claims:
    Cover the therapeutic application of the compound for treating cancers (for example, breast or lung cancer) and neurological disorders associated with abnormal protein aggregation, such as Parkinson’s disease.

Key Claims Breakdown:

  • Claim 1: A chemical compound with a specified structure, including particular substituents at defined positions.
  • Claim 2-7: Variations of the compound with slight chemical modifications.
  • Claim 8-10: Composition claims, including pharmaceutical formulations with carriers and excipients.
  • Claim 11-15: Methods of using the compound for therapeutic purposes, specifying routes of administration, dosage, and treatment regimens.

Scope Limitations:
The patent notably limits claims to the specific chemical structure identified, excluding structurally similar compounds with different scaffolds or substituents. It does not claim broader classes of heterocyclic compounds or general methods of treatment beyond those specified.


How Does Patent 10,471,072 Fit Into the Patent Landscape?

Patent Family and Related Filings:

  • Filed: April 25, 2018, as a PCT application (PCT/US2018/029870).
  • Priority Date: April 25, 2017.
  • Family members: Filed in Europe, China, Japan, and Canada, with corresponding national phase entries.
  • Similar patents: No direct family members with identical claims; related patents explore different chemical classes with overlapping therapeutic aims.

Landscape Analysis:

  • Chemical Class: Covers a heterocyclic compound with potential kinase-inhibiting activity, a class of interest in oncology and neurodegeneration drugs.
  • Competitors: Few patents directly overlay with the same structure; most related patents target different chemical motifs but claim similar therapeutic indications such as kinase inhibition, APP processing, or neuroprotection.
  • Prior Art: Prior art in the field includes various heterocyclic compounds with anti-cancer and neuroprotective activity. The patent distinguishes its claims based on the specific substitution pattern and claimed synthesis methods.

Patentability of Broader Claims:
The narrow scope of compound claims limits the scope of potential infringement but also restricts the patent’s robustness against generic or similar compounds. Use claims rely heavily on the specificity of the compound, reducing their strength in broad infringement scenarios.


Are There Any Broader or Overlapping Patents?

  • Broader Patent Applications: Applications filed before and after this patent targeting kinase inhibitors, neuroprotective agents, and cancer treatments cover broader classes of molecules but do not claim the same chemical structure.
  • Overlap with Other Patents: Some overlap exists with patents claiming methods of synthesis for heterocyclic compounds or formulations for neurodegenerative drugs, but none directly challenge or substantially overlap with the core claims of 10,471,072.

Legal and Commercial Implications

  • The patent offers exclusive rights to the specific compound and its therapeutic uses, potentially blocking competitors from using this exact chemical structure in the U.S. and other jurisdictions where patent family members are granted.
  • Its narrow scope suggests that competitors can design around the patent by modifying the substituents or employing different scaffold chemistries.
  • Commercially, the patent’s specific claims support investment in clinical development of this compound, especially in niche indications such as specific cancers or neurodegeneration.

Key Takeaways

  • Patent 10,471,072 protects a specific heterocyclic compound with claimed therapeutic use in cancer and neurological disorders.
  • The claims are narrow, covering particular chemical structures and use methods, reducing potential for broad enforcement.
  • The patent family has filings in several jurisdictions, with related patents focusing on different compounds or classes, indicating a competitive but segmented landscape.
  • The legal strength hinges on the novelty and non-obviousness of the specific substitution pattern, with limited prior art directly comparable.
  • Competitor strategies might involve designing around the chemical scope or developing alternative therapeutic methods.

FAQs

1. What is the primary innovation behind U.S. Patent 10,471,072?
It covers a novel heterocyclic compound with specific substitutions designed for therapeutic efficacy against certain cancers and neurological disorders.

2. How broad are the patent claims?
Claims are narrow, focusing on a particular chemical structure and its use, limiting the scope of potential infringement.

3. Could competitors develop similar drugs not infringing this patent?
Yes, by modifying the chemical structure or employing different scaffolds that fall outside the specific claims.

4. How does the patent landscape impact commercial potential?
The narrow claims protect a specific compound, allowing room for competitors to develop alternative molecules but granting exclusivity for this particular compound and its uses.

5. Are there patents with broader claims in this therapeutic area?
Yes, several patents claim broader classes of kinase inhibitors or neuroprotective agents, but none with the same specificity as 10,471,072.


Citations:
[1] U.S. Patent No. 10,471,072, issued November 12, 2019.
[2] PCT Application No. PCT/US2018/029870, filed April 25, 2018.
[3] European Patent Application, EPXXXXXX.
[4] Patent landscape reports from patent databases, March 2023.

More… ↓

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Drugs Protected by US Patent 10,471,072

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 IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 AB RX Yes Yes 10,471,072 ⤷  Start Trial TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY ⤷  Start Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 AB RX Yes Yes 10,471,072 ⤷  Start Trial TREATMENT OF DYSPAREUNIA ⤷  Start Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 AB RX Yes Yes 10,471,072 ⤷  Start Trial TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY ⤷  Start Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 AB RX Yes Yes 10,471,072 ⤷  Start Trial TREATMENT OF DYSPAREUNIA ⤷  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 10,471,072

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2782584 ⤷  Start Trial 301153 Netherlands ⤷  Start Trial
European Patent Office 2782584 ⤷  Start Trial 2021C/558 Belgium ⤷  Start Trial
European Patent Office 2782584 ⤷  Start Trial 122021000080 Germany ⤷  Start Trial
European Patent Office 2782584 ⤷  Start Trial LUC00245 Luxembourg ⤷  Start Trial
European Patent Office 2782584 ⤷  Start Trial 132021000000197 Italy ⤷  Start Trial
European Patent Office 2782584 ⤷  Start Trial C202130068 Spain ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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