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;

US Patent 10,039,832: Claim Scope, Expiration, Orange Book Position, and Patent Landscape for Mitomycin C Thermoreversible Hydrogels

US Patent 10,039,832 protects a mitomycin C formulation and treatment method using an intravesical or urinary-tract thermoreversible hydrogel. The core claim requires three formulation elements: 18% to 40% ethylene oxide/propylene oxide block copolymer, HPMC within a specified concentration range, and water. The claims also require mitomycin C at 0.025% to 0.3% w/v.

The patent is directed to the formulation technology used for sustained local delivery of mitomycin C in bladder and upper urinary tract cancer. Its strongest protection is concentrated around the combination of Pluronic-type block copolymer, low-level HPMC, mitomycin C, temperature-dependent viscosity, tissue adhesion, controlled release, and rapid post-treatment degradation. The broadest independent claims are claims 1 and 5. Claims 8 through 23 create narrower technical positions based on rheology, adhesion, flexibility, degradation and release characteristics.

What does US Patent 10,039,832 cover?

US Patent 10,039,832 covers both a pharmaceutical composition and a method of treating urinary tract cancer with that composition.

Claim group	Claim type	Principal subject matter
Claim 1	Method	Treating urinary tract cancer with mitomycin C in a thermoreversible hydrogel
Claims 2-4	Method dependents	Cancer location and mitomycin C concentration
Claim 5	Composition	Mitomycin C hydrogel containing block copolymer, HPMC and water
Claims 6-7	Composition dependents	Additional excipients and narrower mitomycin C concentration
Claims 8-11	Composition dependents	Viscosity, peel strength and tissue flexibility
Claims 12-15	Composition dependents	Polymer structure, degradation and sustained release
Claims 16-23	Method dependents	The same technical properties applied to the treatment method

The patent does not claim mitomycin C as a molecule. Mitomycin C is an established antineoplastic agent. The patent claims its delivery system and use in a specific thermoresponsive formulation.

What are the required elements of independent claim 1?

Claim 1 requires all of the following:

1. A method of treating a urinary tract cancer.
2. A human patient in need of treatment.
3. A pharmaceutical composition.
4. A therapeutically effective amount of mitomycin C.
5. A thermoreversible hydrogel.
6. Ethylene oxide/propylene oxide block copolymer at 18% to 40% w/w.
7. HPMC at 0.05% to 0.5% w/w.
8. Water.
9. Mitomycin C at 0.025% to 0.3% w/v.
10. Administration of the composition to the human.

Claim 1 therefore combines a formulation limitation with a therapeutic-use limitation. A competing product that uses the same hydrogel and mitomycin C concentrations but is marketed only for nonhuman use would not satisfy the express human-treatment limitation. A product administered to a human for a non-urinary cancer also would not literally satisfy claim 1.

The phrase "therapeutically effective amount of an effective amount of a therapeutic agent" is awkwardly drafted. The operative substance identified in the claim is mitomycin C, and the concentration range supplies an objective formulation limitation. The duplicated "effective amount" language may create an interpretive issue, but it does not eliminate the more specific mitomycin C and concentration requirements.

What cancer indications are protected by the patent?

Claim 2 identifies three covered cancer locations:

• Bladder cancer.
• Upper urinary tract cancer.
• Renal pelvis cancer.

The claim structure is broader than a single commercial indication. It reaches treatment of urinary tract cancers generally under claim 1, while claim 2 expressly narrows the site to the listed anatomical categories.

The commercial relevance is greatest for urothelial carcinoma treated by local instillation. The patent language does not require low-grade disease, non-muscle-invasive disease, recurrent disease, or a particular prior treatment history unless those limitations appear in the relevant dependent claim or are imposed by the approved product labeling.

How does claim 5 differ from claim 1?

Claim 5 is a composition claim rather than a treatment-method claim. Its required formulation is:

Component	Claimed range
Ethylene oxide/propylene oxide block copolymer	18% to 40% w/w
HPMC	0.05% to 0.15% w/w
Water	Required
Mitomycin C	0.025% to 0.3% w/v

Claim 5 is narrower than claim 1 with respect to HPMC. Claim 1 permits HPMC up to 0.5% w/w, while claim 5 stops at 0.15% w/w. Claim 5 may be more commercially relevant because an accused product can infringe a composition claim without being sold with an express treatment instruction.

Claims 1 and 5 create two separate enforcement paths:

• Method infringement based on administration to a human.
• Composition infringement based on the formulation itself.

A generic or competing formulation may face composition-claim risk even if its labeling avoids an indication that corresponds exactly to claim 2.

What formulation components are protected?

Claims 3 and 6 contain extensive Markush groups covering additional excipients. The listed categories include:

• Adhesive and thickening compounds.
• Bonding agents.
• Cellulose derivatives.
• Polycarbophil and microcrystalline cellulose.
• PVP, polyethylene glycol and polyethylene oxide.
• Polyvinyl alcohol and partially hydrolyzed polyvinyl acetate.
• Polymethacrylates.
• Diffusion coatings.
• Plasticizers.
• Swellable excipients.
• Water-soluble polymers.
• Matrix-forming polymers.
• Alginates, galactomannans, xanthan gum, pectin, starch and gelatin.

These claims are drafted to prevent easy design-around through substitution of a secondary excipient. The core claim does not require any such additional material, however. A formulation containing only the required block copolymer, HPMC, water and mitomycin C can still fall within claim 5.

The broad excipient lists may also create validity pressure. Potential issues include written description, enablement, claim construction and whether the specification supports the full breadth of each Markush category. Those issues would depend on the patent disclosure and prosecution history, not on the claim text alone.

What rheology and tissue-adhesion properties are protected?

Claims 8 through 13 add measurable performance limitations.

Property	Claimed requirement
Low-temperature viscosity	Less than 5 P·s at 4°C to 12°C
Body-temperature viscosity	Greater than 10^3 Pa·s at 37°C, as transcribed
Peel strength	0.5 to 5.0 under the specified ASTM-based test
Tissue flexibility	3 cm² tissue section stretches to 9 cm² without hydrogel detachment
Alternative viscosity profile	Less than 200 Pa·s at 8°C to 25°C and greater than 3,000 Pa·s at 35°C to 37°C

Claim 8 requires one or more listed properties. Claim 9 requires two or more. Claim 10 requires three or more. Claim 11 requires all listed properties.

This creates a tiered claim strategy:

• Claim 8 is relatively broad among the performance claims.
• Claims 9 and 10 require increasing numbers of performance characteristics.
• Claim 11 is the narrowest combination claim.
• Claims 13 and 21 focus on the alternative viscosity profile.

The viscosity limitations are commercially important because the formulation must be sufficiently fluid at administration temperatures and substantially more viscous at bladder temperature. That temperature response supports retention at the treatment site and distinguishes the claimed formulation from conventional aqueous mitomycin C solutions.

The transcription "greater than 103 Pa·s" appears to omit superscript formatting. It is ordinarily read as "greater than 10^3 Pa·s," but the issued patent and prosecution record should control the final construction.

Does the patent protect sustained release and rapid degradation?

Yes. Claim 12 requires a triblock copolymer having the general formula E101 P56 E101 and complete hydrogel degradation in less than 24 hours after administration to the bladder.

Claim 15 requires continuous release of the therapeutic agent for at least 16 hours. Claims 20 and 23 apply equivalent limitations to the treatment method.

These limitations address two opposing product objectives:

• Retention and sustained release during the treatment period.
• Rapid disappearance of the carrier after the treatment period.

A formulation that releases mitomycin C for less than 16 hours may avoid the release limitation in claim 15, but it could remain exposed to broader claims 1 or 5 if all core composition elements are present.

When does US Patent 10,039,832 expire?

US Patent 10,039,832 issued on August 7, 2018. Its underlying priority and patent-term calculation should be reviewed in the USPTO patent record and terminal-disclaimer data before relying on a precise expiration date.

The patent is generally associated with an expiration date in the mid-2030s, commonly reported as December 2035 for the relevant UroGen formulation estate. The effective date may be affected by patent-term adjustment, terminal disclaimers, disclaimers filed in related applications or other USPTO term records. A commercial freedom-to-operate opinion should therefore use the current USPTO Patent Center record rather than an undated patent database entry. (United States Patent and Trademark Office, 2018a)

Patent expiration is only one exclusivity date. Regulatory exclusivity and other related patents can create separate barriers to generic or competing-product entry.

What is the FDA and Orange Book status of the related mitomycin C product?

The commercial product associated with this technology is Jelmyto, also known as UGN-101, a mitomycin-containing pyelocalyceal solution developed by UroGen Pharma. FDA approved Jelmyto in April 2021 for adult patients with low-grade upper tract urothelial cancer. The product is administered locally into the upper urinary tract rather than as a conventional systemic mitomycin C injection. (FDA, 2021)

Jelmyto received orphan-drug designation for the approved disease setting. The approval created a separate period of orphan-drug exclusivity, generally running for seven years from approval for the protected indication under the Orphan Drug Act, subject to statutory exceptions. Orphan exclusivity does not prevent all competing products in every indication, and it does not replace patent protection.

The Orange Book is the operative FDA source for listed patents and approved-product exclusivity. Patent listings can change as new patents issue, listing disputes arise, or FDA updates its records. Patent 10,039,832 should be evaluated with any later-listed patents covering the product, formulation, use or delivery system. (FDA, 2024)

Are there Paragraph IV challenges to US Patent 10,039,832?

A Paragraph IV certification would assert that a listed patent is invalid, unenforceable or not infringed. The claim text does not establish whether a generic applicant has filed such a certification.

For this technology, the main Paragraph IV targets would likely be:

• The 18% to 40% block-copolymer range.
• The HPMC range.
• The mitomycin C concentration.
• The E101 P56 E101 polymer limitation.
• The viscosity and release limitations.
• The relationship between the approved product and the claimed formulation.

A generic applicant could pursue several strategies:

Strategy	Potential result
Omit HPMC	Possible avoidance of the literal core claims
Use HPMC outside the claimed range	Potential noninfringement, subject to equivalents
Use a different thermoresponsive polymer	Potential noninfringement
Use a different mitomycin C concentration	May avoid selected claims
Avoid the claimed treatment indication	May reduce method-claim exposure
Challenge validity	Could affect all claims if a core limitation is invalidated
File a section viii statement	May avoid a method-of-use patent if FDA permits the carve-out

A formulation applicant cannot rely solely on a label carve-out if the product itself satisfies an unqualified composition claim. Composition claim 5 is therefore more significant to generic entry than method claims limited by disease location or treatment instructions.

Which companies are challenging the patent?

The supplied record does not identify a Paragraph IV filer, ANDA number, litigation caption, settlement agreement or named generic challenger. No challenger can be reliably identified from the claim text alone.

The relevant litigation search should include:

• US Patent 10,039,832.
• Jelmyto.
• UGN-101.
• UroGen Pharma.
• ANDA applicants filing mitomycin pyelocalyceal formulations.
• Hatch-Waxman complaints filed within 45 days of Paragraph IV notice.

Without a verified court docket or FDA filing record, assigning a challenge to a specific company would be unreliable.

How strong is the patent estate?

Strengths

The patent has several commercially meaningful strengths:

1. It claims both the product and the method of use.
2. The core formulation is defined by concentration ranges rather than a single exact recipe.
3. The claims cover the main delivery attributes: low-temperature flow, body-temperature gelation, retention and sustained release.
4. The excipient Markush claims make substitution more difficult.
5. The claims cover bladder and upper urinary tract treatment.
6. The formulation claims can create exposure independent of the prescribing label.

Vulnerabilities

The principal vulnerabilities are:

1. Extensive Markush language may invite written-description and enablement challenges.
2. Several claim terms and units appear technically awkward or transcription-dependent.
3. The performance limitations may require reproducible testing protocols and validated methods.
4. The claims depend on overlapping numerical ranges that may be vulnerable to anticipation or obviousness based on prior thermoreversible hydrogels.
5. The specification must support the claimed combinations of HPMC, block copolymer, mitomycin C and performance characteristics.
6. A competitor may design around the HPMC requirement or use a different thermoresponsive polymer system.

The practical strength is highest against a product that copies the same formulation architecture and rheological behavior. It is weaker against a genuinely different delivery platform.

What generic launch scenarios exist?

Scenario 1: Same hydrogel architecture

A product using mitomycin C, 18% to 40% block copolymer, 0.05% to 0.15% HPMC and water would present substantial literal infringement risk under claim 5.

Scenario 2: Different polymer system

A non-Pluronic thermoresponsive polymer could avoid the express ethylene oxide/propylene oxide limitation. The competitor would still need to assess related patents and potential doctrine-of-equivalents exposure.

Scenario 3: HPMC-free formulation

Removing HPMC may avoid the principal composition claims, although other patent families could cover HPMC-free formulations, manufacturing methods or the same therapeutic use.

Scenario 4: Different concentration

Moving mitomycin C outside 0.025% to 0.3% w/v may avoid claims 1 and 5, but the alternative dose must remain clinically and regulatorily viable.

Scenario 5: Compounded or hospital-prepared product

A hospital-prepared formulation raises separate questions involving direct infringement, induced infringement, product liability, compounding law and whether the product is commercially equivalent to the approved drug. It does not automatically avoid patent liability.

What licensing and commercial risks should be assessed?

The principal commercial risk is not mitomycin C supply. Mitomycin C is an established active pharmaceutical ingredient. The barrier is the integrated delivery platform:

• Low-temperature handling and administration.
• Thermal gelation in the urinary tract.
• Tissue retention.
• Controlled release.
• Short post-treatment degradation.
• Sterile manufacturing.
• Catheter-compatible viscosity.
• Consistent rheological performance.

Any license review should cover the patent family, continuation applications, foreign counterparts, know-how, formulation manufacturing procedures and FDA-approved product rights. A license to one patent does not necessarily provide freedom to operate under later-issued continuation patents or unrelated patents covering the commercial product.

Key Takeaways

• US Patent 10,039,832 protects a mitomycin C thermoreversible hydrogel for urinary tract cancer.
• Independent claim 1 is a human-treatment method claim.
• Independent claim 5 is a composition claim and is the principal barrier to a copycat formulation.
• The core formulation requires 18% to 40% ethylene oxide/propylene oxide block copolymer, HPMC and water.
• Mitomycin C must be present at 0.025% to 0.3% w/v.
• Dependent claims add excipients, E101 P56 E101 polymer structure, viscosity, adhesion, flexibility, degradation and 16-hour release.
• The associated commercial product is Jelmyto, approved by FDA in April 2021 for low-grade upper tract urothelial cancer.
• The patent estate is generally reported to extend into the mid-2030s, subject to the USPTO term record.
• A polymer change, HPMC removal or concentration change may create design-around opportunities.
• No Paragraph IV challenger or settlement can be identified from the supplied claim record.

FAQs

Does US Patent 10,039,832 cover conventional mitomycin C injections?

No. The claims require mitomycin C in a defined thermoreversible hydrogel containing ethylene oxide/propylene oxide block copolymer, HPMC and water.

Does the patent cover bladder instillation products?

Yes. The claims expressly cover bladder cancer and bladder administration-related formulation properties. The commercial risk depends on whether the product meets every limitation of the applicable claim.

Can a competitor avoid the patent by changing only the HPMC concentration?

Potentially. A formulation outside the claimed HPMC range may avoid literal infringement, but the complete patent family, prosecution history and doctrine of equivalents must be assessed.

Is the 16-hour release requirement present in every claim?

No. The 16-hour continuous-release limitation appears in dependent claims 15 and 23. The independent claims do not require that specific release duration.

Does FDA orphan exclusivity last as long as the patent?

No. Orphan exclusivity and patent protection are separate rights with different legal standards, scopes and expiration calculations.

References

1. Food and Drug Administration. (2021). Jelmyto prescribing information. U.S. Department of Health and Human Services. https://www.accessdata.fda.gov
2. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book. U.S. Department of Health and Human Services. https://www.accessdata.fda.gov/scripts/cder/ob/
3. United States Patent and Trademark Office. (2018a). U.S. Patent No. 10,039,832: Thermoreversible hydrogel formulations for treatment of cancer. https://patents.google.com/patent/US10039832B2
4. United States Patent and Trademark Office. (2018b). Manual of Patent Examining Procedure, Chapter 2700: Patent term. https://www.uspto.gov/web/offices/pac/mpep/mpep-2700.html
5. U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, 21 U.S.C. § 355(j).

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