Details for Patent: 9,950,069

« Back to Dashboard

Which drugs does patent 9,950,069 protect, and when does it expire?

Patent 9,950,069 protects ZUSDURI and JELMYTO and is included in two NDAs.

This patent has nine patent family members in six countries.

Summary for Patent: 9,950,069

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:	US15/366,256
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,950,069
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

US Patent 9,950,069: Scope, Claim Analysis, Expiration, and Patent Landscape for Thermoreversible Hydrogel Formulations

US Patent 9,950,069 protects thermoreversible hydrogel compositions containing a poloxamer-type ethylene oxide/propylene oxide triblock copolymer, HPMC, PEG-400, water, and a therapeutic agent. The strongest commercial relevance is the combination of approximately 23% to 27% poloxamer, 0.1% to 0.2% HPMC, 0.5% to 1% PEG-400, and mitomycin C for sustained local treatment in the urinary bladder.

The patent is associated with UroGen Pharma’s RTGel platform and is relevant to JELMYTO, the FDA-approved mitomycin product for primary upper tract urothelial cancer. Its nominal patent term runs into November 2031, subject to any applicable patent-term adjustment or terminal disclaimer. [1][2][3]

What does US Patent 9,950,069 protect?

The patent covers four related protection layers:

1. A defined thermoreversible hydrogel composition.
2. Narrower polymer and excipient concentration ranges.
3. Therapeutic-agent-specific formulations, particularly mitomycin C.
4. Methods for administering the hydrogel to internal body cavities for sustained topical or parenteral treatment.

The broadest formulation claim requires all of the following:

Required element	Claim 1 scope
Ethylene oxide/propylene oxide triblock copolymer	20% to 30% w/w
HPMC	0.05% to 0.3%
PEG-400	0.4% to 2.5%
Therapeutic agent	Effective amount
Remaining component	Water

The claim is composition-based. It does not require a particular delivery device, manufacturing process, indication, or therapeutic agent. A competing formulation can therefore create infringement risk even if it uses a different applicator or targets a different internal cavity, provided the composition satisfies the claimed ranges.

How are the independent claims structured?

The principal independent claims are claims 1, 3, 10, 11 and 15. Claims 23, 27, 28 and 30 add further mitomycin C limitations through dependent-claim chains.

Claims 1 and 15: broad composition protection

Claim 1 covers a hydrogel with a therapeutic agent selected without limiting the agent to a particular drug.

Claim 15 narrows the active ingredient to a specified list, including:

• Mitomycin C
• Gemcitabine
• Thiotepa
• Docetaxel, identified in the claim as Taxotere
• Epirubicin
• Valrubicin
• Apaziquone
• Vicinium
• Botulinum toxin
• Lidocaine
• Thrombin
• Collagen
• Naproxen
• Ibuprofen

Claim 15 is commercially important because it combines the excipient architecture with named active ingredients. For an accused mitomycin C product, this claim avoids some of the breadth and prior-art issues associated with the generic “therapeutic agent” language in claim 1.

Claim 3: the most commercially specific composition claim

Claim 3 requires:

• 23% to 27% of an E101-P56-E101 triblock copolymer
• 0.1% to 0.2% HPMC
• 0.5% to 1% PEG-400
• The balance water

This claim is materially narrower than claim 1. It identifies a particular triblock architecture and tightens all three excipient ranges. The narrower ranges may improve validity against broad prior art, but they also create design-around opportunities.

A formulation that uses 22% poloxamer, 0.09% HPMC or 1.1% PEG-400 could fall outside claim 3 while remaining potentially within claim 1. The relevant question is whether the concentration is measured on the same basis and at the same formulation stage specified by the patent and claim construction.

What formulations are protected by the patent?

Concentration-based protection

The claim set creates overlapping formulation zones:

Formulation element	Broad range	Narrow range
Triblock copolymer	20% to 30%	23% to 27%
HPMC	0.05% to 0.3%	0.1% to 0.2%
PEG-400	0.4% to 2.5%	0.5% to 1%

The commercial formulation is most exposed where it falls within both claim 1 and claim 3. The concentration ranges are not alternatives. Each limitation must be met in combination with the others.

Excipient and formulation-additive protection

Claims 4 through 7 and claims 18 through 21 expand the formulation to include numerous excipient classes. These include:

• Adhesive and thickening agents
• Polycarbophil and crosslinked acrylic polymers
• Cellulose derivatives
• PVP and PVA
• Polyethylene oxide
• Polymethacrylates
• Diffusion coatings
• Plasticizers
• Swellable excipients
• Water-soluble polymers
• Matrix-forming polymers
• PLGA, PNIPAM, polyurethane and polyorganophosphazene
• Stearic acid, glyceryl stearate and cetearyl alcohol

These claims are broad in ingredient selection but remain dependent on the core hydrogel composition. Adding a secondary excipient does not avoid the patent if the base formulation satisfies claim 1, 3 or 15.

The lists also contain repeated ingredients and drafting irregularities. That breadth may support infringement positions, but it can create validity and claim-construction disputes if the specification does not adequately support every listed material or combination.

How does the patent protect mitomycin C bladder formulations?

Claims 23 through 30 concentrate on mitomycin C, bladder administration and product performance.

Performance limitations in claims 23 through 26

The claims recite one or more of the following:

Performance parameter	Claimed limitation
Low-temperature viscosity	Less than 5 Pa·s from 4°C to 12°C
Body-temperature viscosity	Greater than 10³ Pa·s at 37°C
Peel strength	0.5 to 5.0 N−2 as stated in the claim
Tissue flexibility	3 cm² × 3 cm² tissue section stretches to 9 cm² × 9 cm² without detachment

Claims 24, 25 and 26 require progressively more of these characteristics. Claim 26 requires all four.

These limitations are designed to capture a hydrogel that is relatively flowable during administration and becomes highly viscous after exposure to body temperature. The tissue-flexibility requirement targets retention on the bladder wall despite bladder expansion and contraction.

The claims contain potential technical and construction issues:

• “Greater than 103 Pa·s” should be evaluated against the patent record to determine whether it means 10³ Pa·s or 103 Pa·s.
• The peel-strength unit “N−2” is technically unusual and may reflect a transcription or formatting error.
• The viscosity test conditions, shear rate, instrument and equilibration protocol may determine whether an accused product meets the limitation.
• The ASTM D2256-03 reference should be compared with the actual test described in the patent, because ASTM D2256 is generally associated with tensile properties of yarn and fiber rather than conventional hydrogel peel testing.

These limitations may provide useful fallback positions but also create indefiniteness, enablement or reproducibility arguments.

Claims 27 through 30

Claim 27 requires mitomycin C, the E101-P56-E101 copolymer and complete degradation in less than 24 hours after bladder administration.

Claim 28 requires:

• Mitomycin C
• Viscosity below 200 Pa·s at 8°C to 25°C
• Viscosity above 3,000 Pa·s at 35°C to 37°C

Claim 29 limits the use to a therapeutically effective amount for superficial bladder cancer.

Claim 30 requires continuous release of the therapeutic agent for at least 16 hours.

These claims are narrower than the core composition claims. They are potentially valuable against a product with the same thermogelling behavior even if the accused party disputes whether its exact excipient concentrations fall within claim 3.

When does US Patent 9,950,069 lose exclusivity?

The patent was issued on April 24, 2018. Its expected nominal expiration is in November 2031, based on the non-provisional/PCT filing framework associated with the patent. [1]

Event	Date
Earliest priority date	November 2010, based on the patent family record
U.S. patent application filing	2016 national-stage/continuation prosecution history
Patent issued	April 24, 2018
Nominal expiration	November 2031
FDA approval of JELMYTO	December 15, 2020
FDA product exclusivity	Separate from patent term and governed by NDA status

Patent expiration and FDA exclusivity are separate. A drug can lose FDA regulatory exclusivity before the relevant patent expires, and a patent can remain in force after FDA exclusivity ends.

The exact Orange Book expiration listing should be checked against the current FDA Orange Book and the USPTO patent-term records because patent-term adjustment, terminal disclaimers and later corrections can affect the final date. [2][3]

What is the Orange Book status of US Patent 9,950,069?

The patent is relevant to JELMYTO, the mitomycin product marketed by UroGen Pharma for primary upper tract urothelial carcinoma. FDA approved JELMYTO as a mitomycin pyelocalyceal solution on December 15, 2020. The product is administered into the renal pelvis and calyces rather than being approved primarily as a conventional bladder-instillation product. [2]

The patent claims cover a broader set of internal body cavities, including:

• Urinary bladder
• Renal pelvis
• Mouth
• Nasal and paranasal sinus
• Esophagus
• Rectum
• Lungs
• Vagina
• Uterus
• Stomach
• Peritoneum
• Kidney
• Intestine
• Brain
• Vertebral column

The FDA-approved indication does not define the full scope of the patent. A patent method claim can cover uses beyond the approved label, although Orange Book listing and generic-certification consequences depend on the patent’s relation to the approved drug, labeling and dosage form.

What generic entry risks exist?

A generic or follow-on applicant faces several possible patent positions.

ANDA pathway

An ANDA applicant seeking approval for an equivalent mitomycin product could confront:

• Paragraph IV certification to an Orange Book-listed patent
• A 30-month stay if the patent owner files timely infringement litigation
• Product-by-process or formulation equivalence disputes
• Method-of-use concerns if the proposed label overlaps a patented use
• Difficulty designing around the excipient ranges without changing gelation, retention or release performance

The strongest infringement theory would usually involve a product that reproduces the poloxamer-HPMC-PEG-400 architecture. A formulation outside claim 3 may still fall within claim 1 or claim 15.

505(b)(2) pathway

A 505(b)(2) applicant seeking a modified mitomycin delivery system may face a similar patent landscape. The applicant could alter concentration, dosage form, route or indication, but the core hydrogel composition remains the key risk area.

A 505(b)(2) product using the same RTGel-type excipient system could face patent issues even if its proposed indication differs from JELMYTO.

Design-around opportunities

Potential design-around strategies include:

1. Replacing HPMC with another viscosity modifier.
2. Removing PEG-400 or substituting a different molecular-weight PEG.
3. Using a different poloxamer block composition.
4. Moving outside the claimed concentration ranges.
5. Using a non-thermoreversible bioadhesive gel.
6. Using a different active-agent loading or delivery vehicle.
7. Changing the release mechanism so that the product does not satisfy the 16-hour limitation.

Each strategy creates formulation, stability, administration and retention tradeoffs. Avoiding claim 3 alone may not avoid claim 1 or claim 15.

How strong is the patent estate?

US 9,950,069 has a mixed strength profile.

Area	Assessment
Core composition	Stronger where exact excipient ranges are reproduced
Narrow E101-P56-E101 formulation	Stronger against matching commercial formulations
Broad therapeutic-agent claims	Vulnerable to written-description and obviousness challenges
Bladder-use claims	Potentially useful but dependent on method and labeling facts
Performance claims	Useful fallback claims, but testing and measurement disputes are likely
Additive excipient claims	Broad but exposed to prior-art and support challenges
Manufacturing protection	Limited in the supplied claims
Device protection	Limited in the supplied claims
Geographic reach	U.S.-only

The strongest commercial claim combination is likely the intersection of claims 15, 16, 17, 23, 27, 28 and 30 for a mitomycin C thermoreversible hydrogel that matches the specified polymer, HPMC and PEG-400 concentrations and demonstrates the claimed viscosity, degradation or release characteristics.

The weakest portion is the expansive Markush coverage of therapeutic categories and excipients. Patentability depends on the disclosure and priority-date support for the full breadth of those lists.

Which companies are challenging the patent?

The supplied record identifies no specific Paragraph IV challenger, settlement agreement or active patent litigation involving US 9,950,069. The commercial competitive set is therefore better defined by product and technology than by a documented litigation opponent.

Relevant competitive technologies

Technology category	Competitive issue
Standard mitomycin bladder instillation	Lower formulation complexity but shorter residence time
JELMYTO/RTGel	Direct commercial implementation of the thermoreversible platform
Non-poloxamer hydrogels	Potential composition design-around
Mucoadhesive or bioadhesive gels	Compete on tissue retention
Injectable depot systems	Compete on sustained release
Liposomal or nanoparticle mitomycin systems	Compete on exposure and release profile
Drug-eluting devices	Compete on localized delivery without the same hydrogel composition

No biosimilar pathway applies to mitomycin, which is a small-molecule cytotoxic drug. Competitive entry would proceed through an ANDA, 505(b)(2), or a non-equivalent new drug pathway rather than a biosimilar application.

What licensing and geographic rights matter?

US 9,950,069 is a U.S. patent. It does not itself establish rights in Europe, Japan, China or other jurisdictions. International protection must be assessed through the corresponding PCT and national-stage family members.

The commercially relevant rights package may include:

• U.S. composition patents
• Foreign counterparts
• Continuation patents
• Method-of-use patents
• Regulatory exclusivity
• Know-how covering polymer concentration, cooling, storage and administration
• Manufacturing controls for mixing and drug loading
• Device or catheter rights

A freedom-to-operate analysis limited to US 9,950,069 would not capture later-issued continuation patents or foreign rights. Nor would it capture unpublished applications, trade secrets or patents held by third parties covering specific active ingredients, devices or manufacturing steps.

What manufacturing and IP barriers remain?

The patent claims do not expressly require a particular manufacturing process. Commercial barriers may nevertheless arise from:

• Maintaining a homogeneous low-temperature formulation
• Controlling viscosity during filling and administration
• Preserving mitomycin stability
• Achieving consistent gelation at body temperature
• Preventing premature gelation during storage
• Delivering the formulation through a catheter
• Demonstrating adequate tissue retention and drug release
• Validating the claimed viscosity and degradation behavior

A competitor may avoid literal infringement but still face development barriers because the claimed excipient combination appears directed to a specific balance between cold-state flow and warm-state retention.

Key Takeaways

• US 9,950,069 protects thermoreversible hydrogels containing a poloxamer-type triblock copolymer, HPMC, PEG-400, water and a therapeutic agent.
• Claim 3 is the most technically specific composition claim, requiring 23% to 27% E101-P56-E101 polymer, 0.1% to 0.2% HPMC and 0.5% to 1% PEG-400.
• Claims 15 through 17 focus the same platform on named therapeutic agents, including mitomycin C.
• Claims 23 through 30 add viscosity, tissue-retention, degradation and sustained-release limitations for mitomycin C formulations.
• The patent is relevant to UroGen’s JELMYTO and RTGel platform.
• The expected nominal expiration is in November 2031.
• Generic or 505(b)(2) entry risk is highest for products reproducing the same polymer-HPMC-PEG architecture.
• No biosimilar pathway applies because mitomycin is a small molecule.
• The supplied claims contain drafting and measurement issues that could affect claim construction, validity and infringement testing.
• U.S. protection does not establish freedom-to-operate or exclusivity in foreign markets.
• Later continuations, Orange Book listings and family patents must be reviewed alongside US 9,950,069.

FAQs

Is US 9,950,069 limited to mitomycin C?

No. Claims 1 and 8 cover a broad therapeutic-agent framework. Claims 15 and 23 through 30 narrow the invention to specified agents and, in several claims, specifically to mitomycin C.

Does changing the active drug avoid the patent?

Not necessarily. Claim 1 is not limited to a particular active ingredient. A formulation with gemcitabine, lidocaine or another therapeutic agent can still infringe if it satisfies the composition limitations.

Does using a different poloxamer avoid infringement?

Potentially, but not automatically. The product must be evaluated against the structural language covering the ethylene oxide/propylene oxide triblock copolymer and the narrower E101-P56-E101 limitation in claim 3.

Does the patent cover ordinary bladder mitomycin instillation?

Only if the product and administration method satisfy the relevant composition and method claims. A conventional aqueous mitomycin solution without the claimed thermoreversible hydrogel components would generally fall outside the core composition claims.

Can a competitor avoid the patent by changing only PEG-400 concentration?

Changing PEG-400 may avoid claim 3 if the new concentration is outside 0.5% to 1%. It may still fall within claim 1 or claim 15, which recite broader PEG-400 ranges.

References

1. United States Patent and Trademark Office. (2018). U.S. Patent No. 9,950,069, thermoreversible hydrogel formulations and methods of use thereof.

2. U.S. Food and Drug Administration. (2020). JELMYTO (mitomycin) for pyelocalyceal solution: Prescribing information.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.

4. U.S. Food and Drug Administration. (2024). Approved drug product exclusivity and patent information resources.

Drugs Protected by US Patent 9,950,069

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	9,950,069		Y			TREATMENT OF ADULT PATIENTS WITH RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE BLADDER CANCER
Urogen Pharma	JELMYTO	mitomycin	POWDER;PYELOCALYCEAL	211728-001	Apr 15, 2020		RX	Yes	Yes	9,950,069		Y

International Family Members for US Patent 9,950,069

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Germany	212011100034
Denmark	2525777
European Patent Office	2525777
European Patent Office	2734187
Spain	2732150
Israel	221040
Israel	230530