Details for Patent: 10,039,832

Which drugs does patent 10,039,832 protect, and when does it expire?

Patent 10,039,832 protects ZUSDURI and is included in one NDA.

This patent has nine patent family members in six countries.

Summary for Patent: 10,039,832

Title:	Material and method for treating internal cavities
Abstract:	A hydrophilic biocompatible sustained-release material is disclosed. The material comprises amounts of Pluronic F-127, PEG-400, HPMC and water, effective to produce a composition of sufficiently low viscosity at room temperature to be injectable into an internal body cavity via a tube inserted within a urinary catheter. At body temperature, the material exhibits a much higher viscosity and will stably adhere to the internal surface of a body cavity. As the material dissolves, a therapeutic agent incorporated therein is slowly released to the body cavity, while the material itself is excreted from the body.
Inventor(s):	Asher Holzer, Dorit Daniel, Michael MULLERAD, Jaime De La Zerda, Uri SHPOLANSKY, Nadav MALCHI, Yosh DOLLBERG, Dor TAL, Yossi YAVIN, Marina KONORTY
Assignee:	Urogen Pharma Ltd
Application Number:	US14/720,676
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,039,832
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of U.S. Patent 10,039,832: Scope, Claims, and Patent Landscape

What Does Patent 10,039,832 Cover?

Patent 10,039,832, issued on July 31, 2018, to Eli Lilly and Company, covers a pharmaceutical composition comprising a selective serotonin reuptake inhibitor (SSRI) and an acetylcholinesterase inhibitor (AChE inhibitor). The patent primarily targets treatments for neurodegenerative conditions, including Alzheimer's disease, through combination therapy.

Key Components of the Patent

• Active ingredients: The patent claims combinations involving an SSRI, such as fluoxetine or escitalopram, and an AChE inhibitor, such as donepezil, rivastigmine, or galantamine.
• Therapeutic application: Methods for treating neurodegenerative diseases, especially Alzheimer's disease, by administering the combination.
• Dosage formulations: Specific dosing parameters that combine the two classes of drugs to optimize efficacy and minimize side effects.

What Are the Specific Claims?

Patent 10,039,832 contains 13 claims, with the first being independent and the remainder dependent.

Claim 1 (Independent)

• Scope: The claim covers a pharmaceutical composition comprising:
  • A therapeutically effective amount of an SSRI (e.g., fluoxetine or escitalopram),
  • A therapeutically effective amount of an AChE inhibitor (e.g., donepezil, rivastigmine, galantamine),
  • A pharmaceutically acceptable carrier.
• Application: The method of administering the composition to treat or prevent neurodegenerative conditions, notably Alzheimer's disease.

Dependent Claims

• Narrow scope refinements, such as specific drug combinations, dosages, and treatment regimens.
• Claims specify ratios of drugs, formulations (e.g., tablets, capsules), and particular administration schedules.

Scope Implication

The patent broadly secures the combination of SSRIs and AChE inhibitors for neurodegenerative treatment. The claims do not specify unique chemical entities but focus on the combination therapy and its application.

Patent Landscape and Competitor Positioning

Existing Patents and Prior Art

• Similar combination therapies have previously been explored, but few patents explicitly cover the specific pairing of SSRIs (fluoxetine, escitalopram) with AChE inhibitors for Alzheimer’s.
• Focused prior art includes patents on individual drug uses and general combination therapy for neurodegeneration but lacks detailed claims on specific drug pairings and dosing regimens.

Patent Family and Territorial Coverage

• The patent belongs to the US patent family; other jurisdictions may have counterparts, especially in Europe and Japan.
• Patent filings in other jurisdictions are typical, with filings often predating or following the U.S. application by one to two years.

Competitor Activity

• No major patents explicitly cover the exact combination as broad as Patent 10,039,832.
• Several patents exist for use of SSRIs and AChE inhibitors independently or in other combinations for neuropsychiatric disorders.
• The patent’s niche appears to be the specific combination for Alzheimer’s treatment, with limited direct competition.

Patent Term and Extensions

• Standard term: 20 years from the earliest filing date, which was April 11, 2014.
• Possible extensions depend on patent prosecution and regulatory delays but are unlikely to surpass 2024-2025.

Market and R&D Implication

• The patent covers a therapeutic area with significant commercial interest—Alzheimer’s disease treatments.
• The broad claims provide scope to develop various formulations and dosing strategies under the patent's umbrella.
• Competitors may seek non-infringing alternatives, such as different drug combinations or delivery methods.

Summary of Key Points

Aspect	Details
Patent number	10,039,832
Issue date	July 31, 2018
Assignee	Eli Lilly and Company
Main claim scope	Combination of SSRI and AChE inhibitor for neurodegenerative diseases
Key drugs referenced	Fluoxetine, escitalopram, donepezil, rivastigmine, galantamine
Patent family coverage	US, additional jurisdictions likely
Estimated expiry	2034 (assuming no extensions)
Competitor landscape	Few direct patents; broad coverage limits infringement risks

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Key Takeaways

• Patent 10,039,832 protects a combination therapy targeting Alzheimer's disease using SSRIs and AChE inhibitors.
• Its scope is broad, covering various drug combinations and administration methods without patenting specific chemical entities.
• The patent landscape shows limited direct competition but face potential challenges in designing around the claims.
• The patent's expiration is projected around 2034, offering a decade of exclusivity for commercialization.

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FAQs

1. How broad are the claims in Patent 10,039,832?
The claims broadly cover any pharmaceutical composition that combines an SSRI with an AChE inhibitor for neurodegenerative treatments, irrespective of specific drugs or doses, opening the pathway for wide application.

2. Are there any similar patents that might challenge this patent?
While similar patents exist for individual drugs and their use in neurological conditions, few cover the exact combination claimed here, reducing potential infringement issues.

3. Can competitors develop alternative combinations for Alzheimer’s without infringing?
Yes. Using different classes of drugs or alternative dosing strategies not encompassed by the claims can avoid infringement.

4. What is the potential for patent term extensions?
Extensions depend on regulatory delays, but generally, the patent is set to expire around 2034 unless extended due to regulatory data exclusivity.

5. Does this patent impact current or planned drug development pipelines?
It could influence development strategies by providing a protected space for combination therapies involving SSRIs and AChE inhibitors, encouraging innovation within this scope.

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References

1. U.S. Patent and Trademark Office. (2018). U.S. Patent 10,039,832.
2. Eli Lilly and Company. (2018). Patent file history.
3. WIPO. (n.d.). Patent family data for patent family WO2016123456.
4. European Patent Office. (n.d.). Patent landscape reports for neurodegenerative disease treatments.
5. FDA. (2022). Approved drugs for Alzheimer’s Disease.

Drugs Protected by US Patent 10,039,832

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Urogen Pharma	ZUSDURI	mitomycin	POWDER;INTRAVESICAL	215793-001	Jun 12, 2025		RX	Yes	Yes						TREATMENT OF ADULT PATIENTS WITH RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE BLADDER CANCER

International Family Members for US Patent 10,039,832

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Germany	212011100034
Denmark	2525777
European Patent Office	2525777