Lurbinectedin - Generic Drug Details

What are the generic sources for lurbinectedin and what is the scope of freedom to operate?

Lurbinectedin is the generic ingredient in one branded drug marketed by Jazz and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for lurbinectedin

International Patents:	32
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	36
Patent Applications:	184
What excipients (inactive ingredients) are in lurbinectedin?	lurbinectedin excipients list
DailyMed Link:	lurbinectedin at DailyMed

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

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 lurbinectedin

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

Sponsor	Phase
PharmaMar	Phase 2/Phase 3
Stand Up To Cancer	Phase 1/Phase 2
Children's Hospital of Philadelphia	Phase 1/Phase 2

See all lurbinectedin clinical trials

Pharmacology for lurbinectedin

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for lurbinectedin

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for LURBINECTEDIN

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 lurbinectedin

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			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 lurbinectedin

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2270018
European Patent Office	1806349
Hungary	229779	Ecteinascidin analogues, their use in the preparation of a medicament for treatment of cancer and pharmaceutical compositions containing the compounds

Lurbinectedin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lurbinectedin

Introduction to Lurbinectedin

Lurbinectedin, also known as ZEPZELCA, is a marine-derived compound that has garnered significant attention in the oncology sector. Developed by PharmaMar, this drug is an analog of the marine compound ET-736, isolated from the sea squirt Ecteinacidia turbinate. It is a selective inhibitor of oncogenic transcription programs, particularly effective in tumors dependent on these programs[1][3][4].

Market Growth and Forecast

The lurbinectedin market is poised for substantial growth. According to market research, the global lurbinectedin market is expected to witness a growth rate of 45.30% from 2022 to 2029. This rapid growth is driven by several key factors, including the increasing prevalence of cancer globally, advancements in tumor treatment technologies, and the surge in approvals and uptake of premium-priced targeted therapies[1].

Key Drivers of Market Growth

Rising Prevalence of Cancer

The global increase in cancer cases, particularly small cell lung cancer (SCLC) and malignant pleural mesothelioma (MPM), is a major driver of the lurbinectedin market. The drug's efficacy in treating these conditions has made it a critical component in modern oncology[1][3][4].

Technological Advancements and Clinical Trials

The development of new therapies and the ongoing clinical trials to enhance tumor treatments are significant drivers. Lurbinectedin's unique mechanism of action, which involves binding to DNA minor grooves and inhibiting specific cellular processes, has shown promising results in clinical trials[3][4].

Company Collaborations and Regulatory Approvals

Collaborations among pharmaceutical companies to develop new drugs and the accelerated approvals by regulatory bodies such as the FDA have further boosted the market. Lurbinectedin received accelerated approval from the FDA for treating metastatic SCLC, and it has also been granted orphan drug designation for this indication[3].

Healthcare Expenditure and Biotechnology Advancements

Increased healthcare expenditure, changes in lifestyle, and the growing geriatric population are additional factors contributing to the market's growth. The advancements in the biotechnology sector have also opened up profitable opportunities for market players[1].

Market Segmentation

The lurbinectedin market is segmented based on drug classification, end-users, and distribution channels.

Drug Classification

Lurbinectedin falls under various drug classifications, including 3-ring heterocyclic compounds, antineoplastics, and small molecules. This segmentation helps in analyzing niche pockets of growth and strategies to approach the market[1].

End-Users

The primary end-users include hospitals, homecare, specialty clinics, and ambulatory surgical centers. Understanding these segments is crucial for market players to determine their core application areas and target markets[1].

Distribution Channels

The distribution channels include hospital pharmacy, retail pharmacy, and online pharmacy. This segmentation provides insights into the market's reach and accessibility[1].

Financial Trajectory

Revenue and Sales Projections

The financial trajectory of lurbinectedin is promising, with significant revenue projections. For instance, the market forecast indicates substantial sales growth from 2024 to 2032, particularly in the seven major markets (7MM): the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan[4].

Royalty Revenues

PharmaMar, the developer of lurbinectedin, has seen an increase in royalty revenues. For example, in the first half of 2023, royalty revenues totaled €22.8 million, representing a 6% increase compared to the previous year[2].

Competitive Landscape

The competitive landscape of the lurbinectedin market includes major players such as F. Hoffmann La Roche Ltd, Novartis AG, Bayer AG, and others. These companies are investing heavily in research and development, new market initiatives, and global expansions, which further drives the market's financial growth[1].

Challenges and Opportunities

Challenges

Despite the positive outlook, the lurbinectedin market faces challenges such as the availability of various classes of drugs and low awareness among people. These factors are expected to obstruct market growth to some extent[1].

Opportunities

The unique mechanism of action of lurbinectedin and its potential in treating malignant pleural mesothelioma offer significant opportunities. The drug's dual inhibitory effect on tumor-associated macrophages and the nucleotide excision repair mechanism in cancer cells positions it as an innovation in oncology[4].

Clinical and Commercial Future

Clinical Trials and Regulatory Milestones

Lurbinectedin's clinical and commercial future is heavily influenced by ongoing clinical trials and regulatory milestones. The drug's accelerated approval by the FDA and its orphan drug designation are critical steps in its commercial journey[3][4].

Market Forecasts and Competitive Assessments

Detailed market forecasts and competitive assessments, including SWOT analyses, provide a comprehensive view of lurbinectedin's market performance. These analyses help stakeholders understand the drug's competitive standing and potential impact in the global MPM therapeutics market[4].

Key Takeaways

• Rapid Market Growth: The lurbinectedin market is expected to grow at a rate of 45.30% from 2022 to 2029.
• Key Drivers: Increasing cancer prevalence, technological advancements, company collaborations, and regulatory approvals are driving the market.
• Market Segmentation: The market is segmented by drug classification, end-users, and distribution channels.
• Financial Trajectory: Significant revenue projections and royalty revenues indicate a strong financial trajectory.
• Challenges and Opportunities: Despite challenges like drug availability and low awareness, the unique mechanism of action and potential in treating MPM offer substantial opportunities.

FAQs

Q: What is lurbinectedin, and how does it work? A: Lurbinectedin is a marine-derived compound that inhibits oncogenic transcription programs by binding to DNA minor grooves and inhibiting specific cellular processes key to tumor growth.

Q: What are the primary indications for lurbinectedin? A: Lurbinectedin is primarily indicated for the treatment of metastatic small cell lung cancer (SCLC) and shows promise in treating malignant pleural mesothelioma (MPM).

Q: Who are the major players in the lurbinectedin market? A: Major players include F. Hoffmann La Roche Ltd, Novartis AG, Bayer AG, and others, along with the developer PharmaMar.

Q: What are the key drivers of the lurbinectedin market growth? A: The key drivers include the rising prevalence of cancer, technological advancements, company collaborations, and regulatory approvals.

Q: What challenges does the lurbinectedin market face? A: The market faces challenges such as the availability of various classes of drugs and low awareness among people.

Cited Sources

1. Data Bridge Market Research - Global Lurbinectedin Market - Industry Trends and Forecast to 2029[1].
2. PharmaMar Group - PharmaMar Group reports results for the first half 2023[2].
3. FDA - FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer[3].
4. GlobeNewswire - Lurbinectedin Market Forecast for Malignant Pleural Mesothelioma Through 2032[4].