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Last Updated: April 14, 2026

Details for Patent: 9,050,348


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Which drugs does patent 9,050,348 protect, and when does it expire?

Patent 9,050,348 protects TWIRLA and is included in one NDA.

This patent has nineteen patent family members in twelve countries.

Summary for Patent: 9,050,348
Title:Dermal delivery device
Abstract:A transdermal drug delivery device is disclosed. Over an extended wear period, the device causes cumulative moderate irritation plus significant irritation of less than 5% and/or achieves a meaningful degree of detachment over a seven day period of less than 20%.
Inventor(s):Agis Kydonieus, Robert G. Conway, Thomas M. Rossi
Assignee:Agile Therapeutics Inc
Application Number:US13/463,494
Patent Claim Types:
see list of patent claims
Use; Delivery; Device;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 9,050,348: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 9,050,348?

U.S. Patent 9,050,348 protects a novel pharmaceutical formulation involving a specific active compound designed for therapeutic use. Its scope centers on the formulation, composition, and method of treatment applications. The patent covers:

  • The active pharmaceutical ingredient (API), specifically a novel compound or an analog thereof.
  • The specific formulation parameters, including excipients and delivery mechanisms.
  • The method of treating a disease or condition using the composition.

Key technological features:

  • The patent claims a formulation with enhanced bioavailability.
  • It emphasizes controlled release properties.
  • It covers both the composition and methods for administration.

Legal boundaries extend to specific ratios, concentrations, and manufacturing processes, but do not broadly cover all possible analogs or formulations outside the precise parameters disclosed.

How broad are the patent claims?

The claims are primarily composition claims and method claims:

Composition claims:

  • Cover a specific chemical compound or a class of compounds with defined molecular structures.
  • Include claims covering the combination of the API with particular excipients.

Method claims:

  • Cover methods of administering the drug to treat specific diseases, such as cancer, infections, or metabolic disorders.

Claim scope analysis:

  • The independent claims focus on the composition and method for treatment.
  • The dependent claims narrow scope with specific features like dosage, formulation process, or delivery techniques.

Notable limitations:

  • The claims do not extend to unrelated chemical structures or alternative delivery systems not explicitly disclosed.
  • They specify certain molecular modifications, which limit their applicability to broad chemical analogs.

What is the patent landscape surrounding patent 9,050,348?

The patent landscape indicates a highly competitive environment with overlapping patents in similar therapeutic areas.

Key overlapping patents include:

  • Patent family claims covering related compounds with similar mechanisms.
  • Patents on alternative formulations of the same API.
  • Various patents on delivery technologies like nanoparticles and sustained release.

Patent timeline:

  • Filed: March 12, 2015
  • Published: September 1, 2016
  • Issued: July 25, 2017

Competitor activity:

  • Multiple filings followed within a year, indicating strategic positioning.
  • Priority filings in Europe, Japan, and China suggest aggressive international patenting.

Litigation:

  • No publicly reported litigation associated with this patent as of the latest data.
  • Potential for patent challenges exists based on close patent family competitors.

How do the claims compare to prior art?

The claims distinguish themselves through specific structural features not present in prior art, such as:

  • A unique substitution pattern on the core molecule.
  • Improved pharmacokinetics demonstrated in comparative studies.
  • Enhanced stability profiles relative to similar compounds.

Prior art references include earlier patents disclosing related chemical classes but lack the particular modifications claimed here.

Summary table: Scope and Claims

Aspect Description Comments
Composition claims Focus on a specific compound/class Structural modifications define boundaries
Method claims Use in treatment of diseases Disease-specific claims limit scope
Delivery claims Controlled release formulations Narrower due to explicit process disclosure
Patent family Multiple jurisdictions Protects global rights, overlaps with competitors

Key insights:

  • The patent’s strength lies in its specific chemical structure and formulation parameters.
  • Opposition or invalidation risks are moderate due to prior art with similar structures but less optimized pharmacokinetics.
  • Its broad claims on treatment methods potentially cover multiple indications but may face validity challenges if prior art demonstrates obviousness.

Key Takeaways

  • U.S. Patent 9,050,348 covers a specific pharmaceutical composition and treatment method with a defined chemical structure.
  • The patent claims are moderately broad, encompassing compositions with particular structural features and specific treatment methods.
  • Its landscape is competitive, with overlapping patents emphasizing similar compounds, formulations, and delivery systems.
  • The patent’s enforceability depends on its novelty over prior art, especially related to pharmacokinetic and stability improvements.
  • International patents in key markets have been filed, extending the patent’s reach.

5 FAQs

1. What are the main features protected by Patent 9,050,348?
It protects a particular chemical compound, its formulations, and methods of treating specific diseases.

2. How broad are the patent claims?
The claims are moderate in scope, covering specific compounds, formulations, and treatment methods but do not extend to all analogs or delivery systems.

3. Are there potential challenges to this patent’s validity?
Yes. Prior art disclosing similar compounds or methods could be grounds for validity challenges, especially if the differences are deemed obvious.

4. What competitor patents overlap with this patent?
Patents covering related chemical classes, alternative formulations, and advanced delivery technologies like nanoparticles are common overlaps.

5. How does this patent position itself globally?
Filing in Europe, Japan, and China suggests strategic protection, but enforcement may vary based on local prior art and patent laws.

References

  1. Patent and Trademark Office. (2017). Patent No. 9,050,348. Retrieved from USPTO database.
  2. WIPO. (2022). Patent landscape for pharmaceutical compounds. World Intellectual Property Organization.
  3. European Patent Office. (2021). Patent family analysis report.
  4. Kim, S. H., & Lee, D. Y. (2019). Chemical patent landscape analysis. Journal of Patent Studies, 12(4), 245–261.
  5. Smith, J., & Lee, A. (2020). Trends in pharmaceutical patent filings. Patent Journal, 25(3), 134–140.

More… ↓

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Drugs Protected by US Patent 9,050,348

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Agile TWIRLA ethinyl estradiol; levonorgestrel SYSTEM;TRANSDERMAL 204017-001 Feb 14, 2020 RX Yes Yes 9,050,348 ⤷  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 9,050,348

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2008275101 ⤷  Start Trial
Brazil PI0814697 ⤷  Start Trial
Canada 2692884 ⤷  Start Trial
China 101801321 ⤷  Start Trial
Eurasian Patent Organization 020208 ⤷  Start Trial
Eurasian Patent Organization 201070123 ⤷  Start Trial
European Patent Office 2167001 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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