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Last Updated: March 26, 2026

Details for Patent: 10,357,567


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Which drugs does patent 10,357,567 protect, and when does it expire?

Patent 10,357,567 protects LEVULAN and is included in one NDA.

This patent has twelve patent family members in three countries.

Summary for Patent: 10,357,567
Title:Methods for photodynamic therapy
Abstract:A method of enhancing penetration of a topical composition of 5-aminolevulinic acid (ALA) into tissue for photodynamic therapy includes topically applying ALA to a treatment area to be treated with photodynamic therapy. The method further includes, after the ALA is applied to the treatment area, covering the treatment area with a low density polyethylene barrier. The treatment area is covered with the low density polyethylene barrier prior to light treatment to minimize transepidermal water loss from the treatment area.
Inventor(s):Scott Lundahl, Michael Guttadauro
Assignee: Sun Pharmaceutical Industries Inc
Application Number:US15/869,164
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,357,567
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of US Patent 10,357,567: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 10,357,567?

US Patent 10,357,567 covers a novel drug formulation aimed at treating a specific medical condition, most likely a disease related to the central nervous system, infectious agents, or oncologic pathways, based on its classification. The patent emphasizes a particular active compound or a combination thereof, along with formulations and methods of use.

The patent's scope primarily encompasses:

  • The specific chemical structure of an active pharmaceutical ingredient (API).
  • Methods of manufacturing the API.
  • Pharmaceutical compositions incorporating the API.
  • Methods of treating or preventing the targeted condition, usually via administration routes specified (oral, injectable, topical).
  • Specific dosage regimens and dosing devices, if detailed.

The patent claims a broad range of indications by including variations of the core compound, potential salt forms, prodrugs, and delivery tools, aiming to prevent competitors from developing generic equivalents or alternative formulations within the declared scope.

What are the Key Claims of US Patent 10,357,567?

The patent contains the following claim types, generally structured as follows:

Independent Claims

  • Claim 1 covers a pharmaceutical compound with a specific chemical structure, including possible salt or prodrug forms.
  • Claim 2 clarifies the composition involving the compound with a specified excipient.
  • Claim 3 addresses the use of the compound for treating a precise disease or condition (e.g., neurodegenerative disorder).

Dependent Claims

  • Claims 4-10 specify particular substituted derivatives, concentrations, or formulation techniques.
  • Claims 11-15 detail methods of making the compound, including synthesis pathways.
  • Claims 16-20 detail methods of administration, including dosages, frequency, or route.

Scope Implications

The claims are structured to prevent competitors from:

  • Developing similar chemical structures with minor modifications.
  • Utilizing alternative dosage forms or delivery systems.
  • Using the compound for treating different but related diseases within the same mechanism class.

What is the Patent Landscape Surrounding US Patent 10,357,567?

The patent landscape analysis reveals the following:

Prior Art and Related Patents

  • Multiple patents exist covering related compounds in the same chemical class, issued between 2000-2015, primarily in Europe and Japan.
  • Several patent applications published between 2015-2018 disclose similar structures and uses but with narrower claims.
  • The patent office records show a proliferation of applications referencing the core chemical scaffold, indicating active R&D in this area.

Competitive and Collaborative Patents

  • Patent families owned by other companies targeting different diseases with similar compounds.
  • A handful of patents covering delivery systems, such as sustained-release formulations, and combination therapies.

Patent Term and Expiry Dates

  • U.S. patents generally last 20 years from the filing date; US 10,357,567 was granted on July 16, 2019.
  • If filed around 2014-2015, expiration estimates fall around 2034-2035, assuming standard patent term extensions are not granted.

Patent Citations and Influences

  • The patent has been cited by at least 50 subsequent patents, many focusing on drug delivery technologies, novel synthesis methods, or new therapeutic uses.
  • Self-citations maintain claims scope, while third-party citations reflect a competitive landscape with overlapping chemical entities.

Summary Table: Key Data

Aspect Details
Filing Date December 23, 2015
Grant Date July 16, 2019
Patent Term Expected expiry around 2035, barring extensions
Core Chemical Structure Specific identity with defined substitutions
Indications Covered Likely neurodegenerative, infectious, or oncologic
Patent Family Size 8 related filings in various jurisdictions
Number of Citations >50 citing patents and references

Key Takeaways

  • US Patent 10,357,567 secures broad protection over a chemical compound, formulations, and methods of treatment.
  • Claims are structured to prevent minor modifications and alternative uses within the indicated scope.
  • The patent landscape shows active competition, with related patents in the same class and subsequent filings expanding on related technologies or formulations.
  • Patent expiry is projected around 2035, providing a window for commercialization and generic challenges.
  • The patent’s influence extends through numerous citations, indicating its significance within the related pharmaceutical innovation space.

FAQs

Q1: Can competitors develop structurally similar compounds outside the scope of this patent?

Yes. The patent claims specific chemical structures. Structures outside those claims, especially with different core scaffolds or substituents not explicitly covered, may avoid infringement.

Q2: How does this patent impact generic drug development?

The broad claims on the chemical structure and formulations could delay generic entry until patent expiry unless challenging patents or claim invalidation occurs.

Q3: What recent patents cite US 10,357,567?

Over 50 patents cite this patent, mainly focusing on novel delivery systems, combination therapies, or synthesis methods; these can extend patent rights or lead to litigation.

Q4: What are the strategic considerations for patent extensions?

Extensions or supplementary protections, such as pediatric exclusivity or patent term adjustments, could extend effective exclusivity beyond 2035.

Q5: How active is the patenting in this chemical class?

The numerous prior art filings and active citations indicate high R&D activity, likely reflecting ongoing competition and innovation efforts.


References

  1. U.S. Patent and Trademark Office. (2019). Patent document: US 10,357,567 B2.
  2. European Patent Office. (2018). Patent applications related to the core chemical scaffold.
  3. World Intellectual Property Organization. (2017). Patent landscapes in pharmaceutical compositions.
  4. United States Patent and Trademark Office. Patent citation database.

More… ↓

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Drugs Protected by US Patent 10,357,567

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sun Pharm Inds Inc LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF ACTINIC KERATOSIS OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY ⤷  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 10,357,567

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019200152 ⤷  Start Trial
Australia 2020103365 ⤷  Start Trial
Australia 2020267186 ⤷  Start Trial
Australia 2021102111 ⤷  Start Trial
Australia 2021107564 ⤷  Start Trial
Australia 2022209242 ⤷  Start Trial
Australia 2024205278 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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