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JOENJA Drug Patent Profile

When do Joenja patents expire, and when can generic versions of Joenja launch?

Joenja is a drug marketed by Pharming and is included in one NDA. There is one patent protecting this drug.

This drug has forty-five patent family members in thirty-nine countries.

The generic ingredient in JOENJA is leniolisib phosphate. One supplier is listed for this compound. Additional details are available on the leniolisib phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Joenja

Joenja will be eligible for patent challenges on March 24, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 24, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for JOENJA

International Patents:	45
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Drug Prices:	Drug price information for JOENJA
What excipients (inactive ingredients) are in JOENJA?	JOENJA excipients list
DailyMed Link:	JOENJA at DailyMed

See drug prices for JOENJA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for JOENJA

Constraining patent/regulatory exclusivity:

TREATMENT OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA (PI3K DELTA) SYNDROME (APDS) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

NDA:

217759

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for JOENJA

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Phosphoinositide 3-Kinase delta Inhibitors

US Patents and Regulatory Information for JOENJA

JOENJA is protected by one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA (PI3K DELTA) SYNDROME (APDS) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharming	JOENJA	leniolisib phosphate	TABLET;ORAL	217759-001	Mar 24, 2023		RX	Yes	Yes	8,653,092		Y	Y
Pharming	JOENJA	leniolisib phosphate	TABLET;ORAL	217759-001	Mar 24, 2023		RX	Yes	Yes
Pharming	JOENJA	leniolisib phosphate	TABLET;ORAL	217759-001	Mar 24, 2023		RX	Yes	Yes

International Patents for JOENJA

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

Country	Patent Number	Title	Estimated Expiration
Chile	2013000033	Compuestos derivados de tetrahidro-pirido-pirimidina, moduladores de pi3k; composicion farmaceutica que los comprende; combinacion farmaceutica; proceso de preparacion de estos; y su uso en el tratamiento de una enfermedad inflamatoria, autoinmune, cardiovascular, neurodegenerativa, metabolica, oncologica, entre otras
Slovenia	2590974
Dominican Republic	P2013000027	DERIVADOS DE TETRAHIDRO-PIRIDO-PIRIMIDINA
Brazil	112013000275	derivados de tetraidro-pirido-pirimidina
Croatia	P20140778

JOENJA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Drug: Joenja

Introduction

Joenja, also known as leniolisib, is a groundbreaking drug developed by Pharming Group for the treatment of Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS), a rare immune disorder discovered just over a decade ago. Here, we delve into the market dynamics and financial trajectory of this innovative medication.

FDA Approval and Launch

In April 2023, Joenja received FDA approval, marking a significant milestone for Pharming Group. The drug was launched shortly after approval, and its commercial rollout has been swift and successful. This approval and subsequent launch have positioned Joenja as the first and only FDA-approved treatment for APDS[1][4].

Market Uptake

The market uptake of Joenja has been impressive. By the end of 2023, 92 APDS patients in the U.S. were enrolled, with 81 patients on paid therapy. This rapid adoption is a testament to the drug's efficacy and the unmet medical need it addresses. Pharming's efforts to identify and treat APDS patients globally have been instrumental in this success[4].

Revenue Projections and Performance

For the full year 2023, Joenja generated approximately $18.2 million in revenue, driven by the continued increase in patients on paid therapy. This figure is part of Pharming Group's overall revenue growth, which saw a 19% increase to $245.3 million in 2023 compared to the previous year[4][5].

Financial Impact on Pharming Group

The launch of Joenja has had a positive financial impact on Pharming Group. The company's stock price surged 33% on the day of FDA approval, reflecting market optimism about the drug's potential. Global Data predicts that Joenja will generate over $80 million in revenue over the next decade, contributing significantly to Pharming's financial growth[1].

Operating Expenses and Profitability

While Joenja's launch has been successful, it has also led to increased operating expenses for Pharming Group. These expenses include research and development costs for leniolisib, marketing and sales expenses, and payroll increases due to expansion efforts. Despite these costs, the company realized an operating profit of $1.1 million in the fourth quarter of 2023, a significant improvement from the operating loss of $10.2 million in the same period of 2022[2].

Gross Profit and Revenue Growth

The gross profit for Pharming Group increased by $32.0 million, or 17%, to $220.1 million in 2023, primarily due to higher sales of both Joenja and RUCONEST®, another key product of the company. RUCONEST®, used for the treatment of acute Hereditary Angioedema (HAE) attacks, saw a 10% increase in full-year 2023 revenues to $227.1 million[5].

Cash and Marketable Securities

Pharming Group's overall cash and marketable securities position has strengthened, increasing to $215.0 million at the end of 2023 from $208.7 million at the end of 2022. This financial stability is crucial for the company's ongoing research, development, and commercialization efforts[5].

Patient Identification and Global Expansion

Pharming Group has made significant strides in identifying APDS patients globally. As of December 31, 2023, over 840 diagnosed APDS patients have been identified in markets targeted for commercialization. The company is focused on obtaining regulatory approvals and commercializing leniolisib in additional global markets, further expanding the market opportunity for Joenja[4].

Future Development and Market Expansion

Beyond APDS, Pharming is exploring the development of leniolisib for additional primary immunodeficiencies (PIDs) involving PI3Kδ signaling. A Phase 2 proof of concept clinical trial is planned to start in the second quarter of 2024, which could significantly broaden the drug's market potential[4].

Competitive Landscape

In the rare disease biopharmaceutical sector, Pharming Group's commercial acumen and ability to deliver growth for both Joenja and RUCONEST® have been notable. The company's success in navigating the competitive HAE landscape with RUCONEST® and its rapid commercialization of Joenja highlight its strong market position[3].

Pricing Strategy

Pharming Group has taken a relatively conservative stance on pricing Joenja, with a list price of $750 per tablet, or an estimated annual cost of $547,500. This pricing reflects the company's commitment to being a partner of choice for rare disease companies and patients, balancing affordability with the need to sustain long-term investment in research and development[1].

CEO's Perspective

Dr. Sijmen de Vries, CEO of Pharming Group, emphasized the company's dedication to developing and delivering therapies for rare disease patients. He highlighted the excellent year for the company, transforming it into a multi-product, commercial rare disease biopharmaceutical company, and expressed optimism about future growth and expansion[4].

Key Takeaways

• FDA Approval and Launch: Joenja received FDA approval in April 2023 and was launched shortly after, marking a significant milestone.
• Market Uptake: The drug has seen rapid adoption, with 81 patients on paid therapy in the U.S. by the end of 2023.
• Revenue Performance: Joenja generated $18.2 million in revenue in 2023, contributing to Pharming Group's overall revenue growth.
• Financial Impact: The launch has positively impacted Pharming Group's stock price and is expected to generate over $80 million in revenue over the next decade.
• Operating Expenses and Profitability: Increased operating expenses have been offset by higher gross profits, leading to an operating profit in the fourth quarter of 2023.
• Global Expansion and Future Development: Pharming is focused on expanding Joenja's market globally and exploring its use in additional primary immunodeficiencies.

FAQs

What is Joenja used for?

Joenja (leniolisib) is used for the treatment of Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS), a rare immune disorder.

When did Joenja receive FDA approval?

Joenja received FDA approval in April 2023.

How much revenue did Joenja generate in 2023?

Joenja generated approximately $18.2 million in revenue in 2023.

What is the pricing strategy for Joenja?

The list price of Joenja is $750 per tablet, or an estimated annual cost of $547,500, reflecting a relatively conservative stance by Pharming Group.

What are the future development plans for Joenja?

Pharming Group is planning to start a Phase 2 proof of concept clinical trial in the second quarter of 2024 to explore the use of leniolisib in additional primary immunodeficiencies involving PI3Kδ signaling.

Sources

1. PharmaVoice: "A drug just launched for a disease discovered only 10 years ago"
2. Pharming Group: "Pharming Group reports fourth quarter and full year 2023 financial results"
3. NTB Kommunikasjon: "Pharming Group reports third quarter 2023 financial results"
4. Pharming Group: "Pharming Group announces updated full year 2023 guidance and Joenja® U.S. launch update"
5. GlobeNewswire: "Pharming Group reports fourth quarter and full year 2023 financial results"