JELMYTO Drug Patent Profile

Which patents cover Jelmyto, and what generic alternatives are available?

Jelmyto is a drug marketed by Urogen Pharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in six countries.

The generic ingredient in JELMYTO is mitomycin. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mitomycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Jelmyto

A generic version of JELMYTO was approved as mitomycin by HIKMA on April 19^th, 1995.

Summary for JELMYTO

International Patents:	9
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Patent Applications:	2,280
Drug Prices:	Drug price information for JELMYTO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JELMYTO
What excipients (inactive ingredients) are in JELMYTO?	JELMYTO excipients list
DailyMed Link:	JELMYTO at DailyMed

See drug prices for JELMYTO

Recent Clinical Trials for JELMYTO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
City of Hope Medical Center	Phase 2
Mayo Clinic	Phase 2
National Cancer Institute (NCI)	Phase 2

See all JELMYTO clinical trials

Paragraph IV (Patent) Challenges for JELMYTO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JELMYTO	Powder for Injection	mitomycin	40 mg/vial	211728	1	2023-12-28

US Patents and Regulatory Information for JELMYTO

JELMYTO is protected by two US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Urogen Pharma	JELMYTO	mitomycin	POWDER;PYELOCALYCEAL	211728-001	Apr 15, 2020		RX	Yes	Yes			Y
Urogen Pharma	JELMYTO	mitomycin	POWDER;PYELOCALYCEAL	211728-001	Apr 15, 2020		RX	Yes	Yes			Y
Urogen Pharma	JELMYTO	mitomycin	POWDER;PYELOCALYCEAL	211728-001	Apr 15, 2020		RX	Yes	Yes

International Patents for JELMYTO

See the table below for patents covering JELMYTO around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013011504
Israel	230530	חומרים ושיטה לטיפול בחללים של הגוף (Materials and method for treating internal body cavities)
Germany	212011100034
Spain	2732150
World Intellectual Property Organization (WIPO)	2011089604

Market Dynamics and Financial Trajectory for JELMYTO

Introduction to JELMYTO

JELMYTO, developed by UroGen Pharma, is a mitomycin-based drug used for the treatment of low-grade upper tract urothelial cancer (LG-UTUC). It has been making significant strides in the market, driven by its efficacy and growing demand.

Market Demand and Growth

The demand for JELMYTO has been consistently strong, reflecting in its revenue growth. In the first quarter of 2024, JELMYTO generated net product revenues of $18.8 million, a 10% increase from the $17.2 million in the first quarter of 2023[1].

Quarterly Revenue Performance

• In the second quarter of 2024, JELMYTO net product revenues increased to $21.8 million from $21.1 million in the same period of 2023[2][5].
• The third quarter of 2024 saw a further increase, with net product revenues reaching $25.2 million, up from $20.9 million in the third quarter of 2023[3].

Clinical Trials and Efficacy

The success of JELMYTO is also backed by positive clinical trial results. The ENVISION Phase 3 trial for UGN-102, a next-generation formulation, showed an impressive 82.3% duration of response at 12 months[2].

ENVISION Study Highlights

• The ENVISION study data, which will be discussed in a company-sponsored virtual event, is expected to support the completion of the UGN-102 New Drug Application (NDA) in Q3 2024[1].
• The study demonstrated favorable recurrence-free survival rates for patients with LG-UTUC, consistent across different administration methods, tumor sizes, and locations[1].

Financial Performance

UroGen Pharma's financial performance is closely tied to the success of JELMYTO.

Revenue Guidance

• For the full year 2024, the company is guiding net product revenues from JELMYTO in the range of $95 to $102 million, despite increased discounts related to Medicare refunds and 340B purchases[1].

Operating Expenses

• Research and development expenses for the first quarter of 2024 were $15.5 million, and for the second quarter, they were $15.4 million. Selling, general, and administrative expenses also increased, reflecting the company's investment in growth[1][2].
• The company expects full-year 2024 operating expenses to be in the range of $175 to $185 million, including non-cash share-based compensation expenses[1].

Cash Position

• As of June 30, 2024, UroGen Pharma had a strong cash position of $241.3 million, and as of September 30, 2024, this increased to $254.2 million in cash, cash equivalents, and marketable securities[2][3].

Recent Corporate Developments

Several recent developments have contributed to UroGen Pharma's financial trajectory.

Public Offering

• In July 2024, the company completed a public offering that raised approximately $107.5 million in gross proceeds, further strengthening its financial position[2].

NDA Submission

• The NDA for UGN-102 has been accepted by the FDA, with a PDUFA target action date set for June 13, 2025. This marks a significant milestone and is ahead of the initial schedule[3].

Market Expansion and Adoption

The growing adoption of JELMYTO is supported by real-world outcomes data and its use in diverse patient populations.

Real-World Data

• Independent long-term real-world analyses presented at the AUA 2024 Annual Meeting showed favorable recurrence-free survival rates for patients with LG-UTUC, regardless of the administration method or tumor characteristics[1].

Activated Sites and Repeat Accounts

• The number of activated sites and repeat accounts has also seen an increase, indicating sustained market interest and patient adherence to the treatment[4].

Challenges and Outlook

While JELMYTO has shown strong market dynamics and financial growth, there are challenges to consider.

Operating Losses

• Despite revenue growth, UroGen Pharma reported a net loss of $33.4 million in the second quarter of 2024, up from $24.1 million in the same period of 2023. This is largely due to increased operating expenses[2].

Future Projections

• The company is expected to be toward the higher end of its full-year 2024 operating expense guidance, reflecting continued investment in research, development, and marketing[2].

Key Takeaways

• Strong Revenue Growth: JELMYTO has consistently shown revenue growth, with a 10% increase in Q1 2024 and further increases in Q2 and Q3.
• Positive Clinical Trials: The ENVISION study and other trials have demonstrated the efficacy of JELMYTO and its next-generation formulation.
• Solid Financial Position: UroGen Pharma has a strong cash position and has raised additional capital through public offerings.
• Market Expansion: Growing adoption and real-world data support the use of JELMYTO in diverse patient populations.

FAQs

What is JELMYTO used for?

JELMYTO is used for the treatment of low-grade upper tract urothelial cancer (LG-UTUC).

What are the recent revenue figures for JELMYTO?

In Q1 2024, JELMYTO generated $18.8 million in net product revenues. In Q2 2024, this increased to $21.8 million, and in Q3 2024, it reached $25.2 million.

What are the key findings from the ENVISION study?

The ENVISION study showed an 82.3% duration of response at 12 months for UGN-102, a next-generation formulation of JELMYTO.

What is the current cash position of UroGen Pharma?

As of September 30, 2024, UroGen Pharma had $254.2 million in cash, cash equivalents, and marketable securities.

When is the FDA decision expected for UGN-102?

The FDA decision for UGN-102 is expected by June 13, 2025, following the acceptance of the NDA submission.

Cited Sources:

1. UroGen Pharma Announces Date for ENVISION Data, New Long-Term JELMYTO Durability Data and Reports 2024 First Quarter Financial Results and Business Highlights. Biospace.
2. UroGen Pharma Ahead of Schedule to Complete UGN-102 NDA Submission. Stock Titan.
3. UroGen Pharma Reports 2024 Third Quarter Financial Results and Business Highlights, Including the Potential Launch of UGN-102 in 2025. UroGen Pharma Investors.
4. UroGen Pharma Reports Record JELMYTO Quarterly Sales and Recent Corporate Developments. UroGen Pharma Investors.
5. UroGen Pharma Ahead of Schedule to Complete UGN-102 NDA Submission and Reports Second Quarter 2024 Financial Results. UroGen Pharma Investors.