Lurbinectedin Patent Expiration

Lurbinectedin is Used for treating small cell lung cancer in adult patients who have progressed on or after platinum-based chemotherapy. It was first introduced by Jazz Pharmaceuticals Ireland Ltd in its drug Zepzelca on Jun 15, 2020.


Lurbinectedin Patents

Given below is the list of patents protecting Lurbinectedin, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Zepzelca US12324806 Method of treating SCLC and managing hepatotoxicity May 29, 2040 Jazz
Zepzelca US12433890 Method Of Treating Sclc And Managing Neutropenia May 29, 2040 Jazz
Zepzelca US12440490 Method Of Treating Sclc And Managing Thrombocytopenia May 29, 2040 Jazz
Zepzelca US7763615 Ecteinascidin analogs for use as antitumour agents Dec 13, 2029 Jazz



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Lurbinectedin's patents.

Given below is the list recent legal activities going on the following patents of Lurbinectedin.

Activity Date Patent Number
Patent litigations
Patent Term Extension Certificate 17 Oct, 2023 US7763615
Electronic Review 06 Jun, 2023 US7763615
Notice of Final Determination -Eligible 15 May, 2023 US7763615
Notice of Final Determination -Eligible 25 Jan, 2023 US7763615
FDA Final Eligibility Letter 29 Aug, 2022 US7763615
Payment of Maintenance Fee, 12th Year, Large Entity 12 Jan, 2022 US7763615
transaction for FDA Determination of Regulatory Review Period 05 Nov, 2021 US7763615
Second letter to regulating agency to determine regulatory review period 20 May, 2021 US7763615
Letter from FDA or Dept of Agriculture re PTE application 14 Dec, 2020 US7763615
Initial letter Re: PTE Application to regulating agency 17 Nov, 2020 US7763615


Lurbinectedin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Lurbinectedin:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON) PharmaMar NA COMPLETED
(Sep 1, 2026)
PHASE3
Lurbinectedin in FET-Fused Tumors Children's Hospital of Philadelphia NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE) Zai Lab (Shanghai) Co., Ltd. NA RECRUITING
(Sep 1, 2026)
PHASE3
Clinical Study in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT) ISG-TULIPS Italian Sarcoma Group NA RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer AbbVie NA RECRUITING
(Sep 1, 2026)
PHASE3
Lurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung Cancer Yonsei University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
Lurbinectedin + Doxorubicin In Leiomyosarcoma Massachusetts General Hospital NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer M.D. Anderson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE1
A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer Daiichi Sankyo NA RECRUITING
(Aug 1, 2026)
PHASE3
Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer Gilead Sciences NA RECRUITING
(Aug 1, 2026)
PHASE3
Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo) PharmaMar NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
An Exploratory Study of Lurbinectedin With Radiotherapy in SCLC With Single-lesion Progression After First Course Treatment Cancer Institute and Hospital, Chinese Academy of Medical Sciences NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer Misty Shields NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
A Clinical Study for the Safety and Efficacy of BL0020 Injection in Combination With Toripalimab Injection in Patients With Recurrent Extensive-Stage Small Cell Lung Cancer Shanghai Best-Link Bioscience, LLC NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE1
Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Mar 13, 2026)
PHASE1, PHASE2
Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer Mayo Clinic NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC VA Office of Research and Development NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2


Lurbinectedin Generic API Manufacturers

Given below is the list of companies who have filed for Lurbinectedin generic, along with the locations of their manufacturing plants worldwide.