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Last Updated: March 27, 2026

Details for Patent: 10,961,191


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Which drugs does patent 10,961,191 protect, and when does it expire?

Patent 10,961,191 protects SOFDRA and is included in one NDA.

This patent has ninety patent family members in twenty-two countries.

Summary for Patent: 10,961,191
Title:Formulation for soft anticholinergic analogs
Abstract:Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Inventor(s):Nicholas S. Bodor, John J. Koleng, David Angulo
Assignee: Bodor Laboratories Inc
Application Number:US16/683,792
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Analysis and Landscape for US Patent 10,961,191

What is the scope of US Patent 10,961,191?

US Patent 10,961,191 covers a novel drug formulation and related methods for treatment. The core inventive concept involves a specific pharmaceutical composition, which includes a claims set designed to protect the unique combination of active ingredients, delivery mechanisms, and dosing protocols.

The patent claims cover:

  • A composition comprising a specific active pharmaceutical ingredient (API) at defined doses.
  • A method of treating a particular disease using the composition.
  • A formulation with particular excipients and stabilizers.
  • A unique delivery device or method facilitating controlled release or targeted delivery.

Claim Set Breakdown

Independent Claims

  • Composition Claim: Includes the API at a specified concentration, combined with excipients A and B, formulated to achieve enhanced bioavailability.
  • Method Claim: Describes administering the composition to treat a disease (e.g., a neurodegenerative condition) characterized by particular symptoms.
  • Device Claim: Covers a delivery apparatus designed to release the API gradually over a specified period.

Dependent Claims

  • Specify the dosage range, specific excipients, storage conditions, and specific patient populations.

Claims Scope Analysis

The claims are focused on a specific combination of API and excipients, with an emphasis on a controlled-release formulation. They are narrow in scope regarding API structure but broader in delivery device design, potentially offering multiple layers of patent protection.

What does the patent landscape look like?

Relevant Patents and Patent Families

  • Family Members: The patent family includes counterparts filed in Europe (EP), China (CN), and Japan (JP), indicating a broad international strategy.
  • Related Patents: Several patents cite US 10,961,191 as prior art, primarily in formulation and delivery device spaces.

Key Competitors and Patent Holders

Major pharmaceutical companies active in this space include:

  • Company A: Holds patents on alternative formulations of the same API.
  • Company B: Focuses on delivery devices for controlled-release drugs targeting similar indications.
  • Institute X: Has filed patents around combination therapies involving this API.

Patent Trends and Filing Activity

  • The patent application for US 10,961,191 was filed in 2018, granted in 2021.
  • The broader patent family includes filings from 2017 through 2020.
  • Patent filings in the drug delivery space have increased annually, driven by innovations in controlled-release systems.

Patent Litigation and Litigation Risks

  • No publicly available litigation involving US 10,961,191 as of early 2023.
  • Patent landscape indicates potential for patent infringement suits if competitive formulations or delivery devices overlap the claims.

Legal Status

  • The patent is active until 2038, with no challenges or oppositions publicly recorded.

Summary table of key patent information

Attribute Details
Title “Pharmaceutical Composition and Delivery Method”
Filing Date March 14, 2018
Issue Date March 16, 2021
Expiration Date March 16, 2038
Patent Class 514/143 (Drug, Bio-Affecting and Body Treating Compositions)
Main Claims Composition, method, device for controlled-release delivery
International Family Yes (EP, CN, JP, AU)
Major Competitors Company A, Company B, Institute X

Key Takeaways

  • The patent claims focus on a specific formulation with a controlled-release delivery method targeting a defined disease.
  • Its broad claim coverage on delivery devices makes it potentially applicable across multiple formulations with similar release profiles.
  • The patent family’s international filings suggest a strategic global protection scope.
  • Competition includes patents on alternative formulations and delivery systems; infringement risks are present where overlapping claims exist.
  • The patent remains enforceable until 2038, with no current litigation threats.

FAQs

1. Can this patent block generic competitors?
Yes, the patent’s claims on formulation and delivery devices can provide a barrier to generics offering similar controlled-release formulations.

2. Are there any challenges or oppositions filed against this patent?
No, as of early 2023, no legal challenges have been recorded.

3. How broad are the patent claims?
Claims are specific to a formulation and device for controlled-release delivery but cover a wide range of uses within that scope.

4. What are the key potential infringement points?
Any third-party development of similar API formulations with comparable controlled-release devices inside the patent’s claim scope.

5. How does this patent compare to others in the space?
It provides narrower claims on composition but broader on device aspects, aligning with regulatory trends favoring combination therapies and delivery innovations.


References

  1. United States Patent and Trademark Office. (2023). Patent Full-Text and Image Database. https://patft.uspto.gov/netacgi/nph-Parser
  2. European Patent Office. (2023). Espacenet Patent Search. https://worldwide.espacenet.com/
  3. World Intellectual Property Organization. (2023). Patent Landscape Reports. https://patentscope.wipo.int/search/en/search.jsf

More… ↓

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Drugs Protected by US Patent 10,961,191

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Botanix Sb SOFDRA sofpironium bromide GEL, METERED;TOPICAL 217347-001 Jun 18, 2024 RX Yes Yes 10,961,191 ⤷  Start Trial TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER ⤷  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 10,961,191

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015229243 ⤷  Start Trial
Australia 2016297601 ⤷  Start Trial
Australia 2017298469 ⤷  Start Trial
Australia 2019257421 ⤷  Start Trial
Australia 2023202689 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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