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ZEPZELCA Drug Patent Profile

When do Zepzelca patents expire, and what generic alternatives are available?

Zepzelca is a drug marketed by Jazz and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Zepzelca

Zepzelca was eligible for patent challenges on June 15, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 13, 2029. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for ZEPZELCA

International Patents:	32
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	4
Patent Applications:	58
Drug Prices:	Drug price information for ZEPZELCA
What excipients (inactive ingredients) are in ZEPZELCA?	ZEPZELCA excipients list
DailyMed Link:	ZEPZELCA at DailyMed

See drug prices for ZEPZELCA

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

Constraining patent/regulatory exclusivity:

7,763,615

NDA:

213702

Dosage:

POWDER;INTRAVENOUS

^*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.

Recent Clinical Trials for ZEPZELCA

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

Sponsor	Phase
Emory University	Phase 1
National Cancer Institute (NCI)	Phase 1
Jazz Pharmaceuticals	Phase 1

See all ZEPZELCA clinical trials

Pharmacology for ZEPZELCA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Paragraph IV (Patent) Challenges for ZEPZELCA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZEPZELCA	Powder for Injection	lurbinectedin	4 mg/vial	213702	5	2024-06-17

US Patents and Regulatory Information for ZEPZELCA

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

This potential generic entry date is based on patent 7,763,615.

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
Jazz	ZEPZELCA	lurbinectedin	POWDER;INTRAVENOUS	213702-001	Jun 15, 2020		RX	Yes	Yes	7,763,615		Y	Y
Jazz	ZEPZELCA	lurbinectedin	POWDER;INTRAVENOUS	213702-001	Jun 15, 2020		RX	Yes	Yes
Jazz	ZEPZELCA	lurbinectedin	POWDER;INTRAVENOUS	213702-001	Jun 15, 2020		RX	Yes	Yes

International Patents for ZEPZELCA

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1414828
Japan	4684552
Hungary	229779	Ecteinascidin analogues, their use in the preparation of a medicament for treatment of cancer and pharmaceutical compositions containing the compounds
Hong Kong	1065786

ZEPZELCA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zepzelca

Introduction to Zepzelca

Zepzelca, also known as lurbinectedin, is a chemotherapy drug developed by PharmaMar and commercialized in the U.S. by Jazz Pharmaceuticals. It is primarily used for the treatment of small cell lung cancer (SCLC), a disease with limited treatment options and a high recurrence rate after traditional chemotherapy[1].

Approval and Initial Impact

Zepzelca was approved by the U.S. FDA in June 2020 under an accelerated approval program based on its overall response rate (ORR) and duration of response. The drug demonstrated an ORR of 35% and a median duration of response of 5.3 months, as assessed by both investigators and an independent review committee[1].

Market Dynamics

Growing Demand in Oncology

The global oncology drugs market, which includes Zepzelca, is projected to grow significantly. Valued at $231.56 billion in 2024, the market is expected to reach $532.91 billion by 2031, growing at a CAGR of 12.6%. This growth is driven by the rising demand for targeted therapies and advancements in drug delivery systems, which have led to more effective and safer treatments[3].

Targeted Therapies and Combination Treatments

Zepzelca's market potential is further enhanced by its use in combination therapies. Recent Phase 3 clinical trial results showed that Zepzelca combined with atezolizumab significantly improved overall survival and progression-free survival in patients with extensive-stage SCLC compared to atezolizumab alone. This combination is expected to change the standard of care for these patients and expand Zepzelca's market share[4].

Financial Performance

Revenue Growth

Zepzelca has shown steady revenue growth since its approval. In 2023, Zepzelca's net product sales increased by 7% to $289.5 million compared to 2022. In the fourth quarter of 2023, sales increased by 3% to $74.0 million compared to the same period in 2022[5].

Licensing Agreements

The financial trajectory of Zepzelca is also influenced by licensing agreements. Jazz Pharmaceuticals entered into an exclusive license deal with PharmaMar in December 2019, paying $200 million upfront and committing to up to $800 million in milestones and royalties. In the first half of 2023, Jazz recognized $12.1 million in revenue from the Zepzelca license agreement with PharmaMar[2].

Revenue Streams and Milestones

Oncology Segment Revenue

PharmaMar's revenue from Zepzelca in Europe, primarily under early access programs, contributed significantly to their oncology segment. In the first half of 2023, net revenues from Zepzelca in Europe were €21.0 million. However, overall oncology sales for PharmaMar decreased by 30% in the first half of 2023 compared to the same period in 2022, mainly due to the impact of generic competition on their other product, Yondelis[2].

Milestones and Royalties

Jazz Pharmaceuticals is set to submit a supplemental New Drug Application (sNDA) in the first half of 2025 for the combination of Zepzelca and atezolizumab as a first-line maintenance treatment for ES-SCLC. If approved, this could lead to significant revenue growth and expanded market opportunities for Zepzelca. The combination's efficacy and manageable safety profile position it as a promising new option, potentially increasing Zepzelca's market share and revenue[4].

Future Outlook

Expanded Market Opportunities

The potential approval of Zepzelca in combination with atezolizumab for first-line maintenance therapy could substantially increase its market share and revenue. This expansion into the first-line maintenance setting would allow Jazz to capture a larger patient population earlier in the treatment cycle, which is crucial given that ES-SCLC affects a significant number of patients annually[4].

Financial Impact

While the financial impact of this potential approval would not be realized until late 2025 or 2026, it is expected to drive revenue growth and improve Jazz's market position in oncology. Investors are keenly watching the planned sNDA submission and its potential to enhance Zepzelca's financial trajectory[4].

Key Takeaways

• Market Growth: The global oncology drugs market is expected to grow significantly, driven by targeted therapies and advancements in drug delivery.
• Combination Therapies: Zepzelca's combination with atezolizumab has shown statistically significant improvements in overall survival and progression-free survival for ES-SCLC patients.
• Revenue Growth: Zepzelca has seen steady revenue growth, with a 7% increase in net product sales in 2023.
• Licensing Agreements: Significant revenue is generated through licensing agreements, including the deal between Jazz Pharmaceuticals and PharmaMar.
• Future Outlook: Potential approval for first-line maintenance therapy could expand Zepzelca's market share and revenue, though financial impacts are expected to be realized in late 2025 or 2026.

FAQs

1. What is Zepzelca used for? Zepzelca (lurbinectedin) is used for the treatment of small cell lung cancer (SCLC), particularly in patients whose disease has progressed on or after platinum-based therapy.

2. How was Zepzelca approved? Zepzelca was approved by the U.S. FDA in June 2020 under an accelerated approval program based on its overall response rate and duration of response.

3. What are the recent clinical trial results for Zepzelca? Recent Phase 3 clinical trials showed that Zepzelca combined with atezolizumab significantly improved overall survival and progression-free survival in patients with extensive-stage SCLC compared to atezolizumab alone.

4. How much revenue has Zepzelca generated? In 2023, Zepzelca's net product sales increased by 7% to $289.5 million. In the fourth quarter of 2023, sales increased by 3% to $74.0 million compared to the same period in 2022.

5. What are the future market prospects for Zepzelca? The potential approval of Zepzelca in combination with atezolizumab for first-line maintenance therapy could substantially increase its market share and revenue, capturing a larger patient population earlier in the treatment cycle.

Sources

1. Biospace: Jazz Pharma Gets Approval for Zepzelca in the U.S. for Aggressive Small Cell Lung Cancer[1].
2. CNMV: Group revenue in the first half of 2023[2].
3. Biospace: Oncology Drugs Market to Reach USD 532.91 Billion by 2031[3].
4. Stocktitan: Jazz Pharmaceuticals Announces Statistically Significant Overall Survival and Progression-Free Survival Results for Zepzelca® (lurbinectedin) and Atezolizumab Combination[4].
5. PR Newswire: Jazz Pharmaceuticals Announces Full Year and Fourth Quarter 2023 Financial Results and Provides 2024 Financial Guidance[5].