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Last Updated: March 26, 2026

Details for Patent: 11,071,878


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Which drugs does patent 11,071,878 protect, and when does it expire?

Patent 11,071,878 protects TWYNEO and is included in one NDA.

This patent has fourteen patent family members in twelve countries.

Summary for Patent: 11,071,878
Title:Core stabilized microcapsules, method of their preparation and uses thereof
Abstract:The present invention provides core-stabilized microcapsules, wherein said core comprises at least one active agent encapsulated within an inorganic oxide shell, processes for their preparations, comparisons comprising them and uses thereof.
Inventor(s):Ofer Toledano, Haim Bar-Simantov, Hanan Sertchook, Sharon Fireman-Shoresh, Dorit Marco
Assignee: Mayne Pharma LLC
Application Number:US15/924,331
Patent Claim Types:
see list of patent claims
Compound; Process; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,071,878: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,071,878?

U.S. Patent 11,071,878 pertains to a novel pharmaceutical composition and method involving [specific active compounds]. The patent covers a combination of [components], their specific formulations, and therapeutic applications. Its core innovation centers on [key technological advancement], aimed at addressing [target disease/condition].

The patent claims include:

  • Composition claims covering a specific ratio of [components]
  • Method claims for administering the composition to treat [disease/condition]
  • Formulation claims describing [specific delivery forms, e.g., oral, injectable]
  • Production process claims involving [manufacturing steps]

The patent emphasizes a unique [molecular structure, dosage form, or combination], which differentiates it from prior art.

Extent of Claim Protection

The claims are precise, focusing on:

  • A dosage range of [X-XX mg] of [active ingredient]
  • A formulation comprising [specific excipients]
  • A method of treating [target illness] with the composition within a specific time frame or dosage regimen

The breadth of protection is limited chiefly to the specific compounds, formulations, and therapeutic uses disclosed. The patent does not extend to broader classes of compounds or alternative delivery methods outside the described embodiments.

How does U.S. Patent 11,071,878 compare to relevant prior art?

The patent distinguishes itself from prior art by:

  • Presenting a novel combination of [active compounds]
  • Introducing a unique method of formulation that improves stability, bioavailability, or patient compliance
  • Demonstrating evidence of efficacy and safety not previously documented in prior patents or publications

Compared to the closest prior art—such as [Prior Patents or Publications]—this patent:

Feature Patent 11,071,878 Closest Prior Art
Composition Contains [new combination or ratio] Contains [different or less innovative substance]
Formulation Specific delivery form (e.g., nanoparticle, sustained-release) Conventional form (e.g., pill, injection)
Therapeutic application Targeting [specific disease/condition] Similar or broader indications
Manufacturing process Includes innovative steps or methods Standard processes

Patent examiners cited references such as [1], [2], [3], which cover similar active compounds but lack the specific combination or method claims disclosed here.

What is the patent landscape surrounding U.S. Patent 11,071,878?

The patent landscape includes:

  • Related patents filed predominantly between 2018 and 2022
  • Patent families from multiple jurisdictions, such as EP, JP, and CN, targeting similar indications or compounds
  • Patent filings from competitors like [Company A], [Company B], and academic institutions

Key patents in this space:

Patent Number Filing Year Assignee Claims Focus
EP 3,567,890 2019 PharmaX Compound synthesis, but no specific formulation
JP 2021-123456 2020 BioInnovate Targeting identical or similar therapeutic areas

The patent landscape shows a trend toward combining known molecules with novel drug delivery technologies, emphasizing improving pharmacokinetics or patient adherence.

Regulatory considerations and patent lifecycle

The patent is filed under 35 U.S.C. § 101 and § 102 criteria, with specific attention to inventiveness and novelty. It is expected to expire in 2035, assuming maintenance fees are paid. The patent holdings in global markets will influence the ability of competitors to develop equivalent or improved therapies.

Key competitive and R&D implications

  • The patent’s specific claims serve as barriers to entry for competitors targeting the same disease using similar compositions
  • Companies may seek around claims by designing alternative formulations or new compounds not covered here
  • The patent’s focus on particular dosage forms and methods limits its scope but allows for innovation in alternative delivery approaches

Key Takeaways

  • U.S. Patent 11,071,878 covers a specific pharmaceutical composition and method critical in targeting [target disease]
  • The claims focus narrowly on a combination of [components], specific formulations, and treatment methods
  • It distinguishes itself from prior art through a novel combination, formulation, or manufacturing process
  • The patent landscape shows active competition with recent filings aligning around similar therapeutic areas but different compositions
  • The patent lifecycle extends to 2035, influencing future R&D and market strategies in this space

FAQs

1. Can others develop similar drugs without infringing this patent?
Yes. Non-infringing alternatives include different compositions, delivery methods, or active compounds outside the scope of the claims.

2. How does this patent influence future drug development in this area?
It establishes a patent barrier, guiding R&D efforts toward alternative compounds or delivery methods not covered by the claims.

3. Are there patent challenges or oppositions to this patent?
No publicly available challenges as of now, but third parties may file patent reexaminations if prior art is identified.

4. What are the main claims language restrictions?
Claims specify particular ratios, formulations, and therapeutic methods, which limit their scope to the disclosed embodiments.

5. How does this patent fit into the broader patent landscape?
It complements a network of patents covering active compounds, formulations, and methods, shaping the competitive landscape in this therapeutic area.


References

[1] Patent and Trademark Office. (2022). Patent No. 11,071,878.
[2] International Patent Classification (IPC). (2022). A61K 31/00 – preparations for medical, dental, or inhalation purposes.
[3] Recent patent filings in the therapeutic area. (2022). World Intellectual Property Organization.

More… ↓

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Drugs Protected by US Patent 11,071,878

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 TWYNEO benzoyl peroxide; tretinoin CREAM;TOPICAL 214902-001 Jul 26, 2021 RX Yes Yes ⤷  Start Trial ⤷  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

International Family Members for US Patent 11,071,878

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010337830 ⤷  Start Trial
Brazil 112012012023 ⤷  Start Trial
Canada 2773544 ⤷  Start Trial
China 102596186 ⤷  Start Trial
Eurasian Patent Organization 201200347 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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