Prescription medicine
Lurbinectedin Brand names: Zepzelca
Lurbinectedin (Zepzelca) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the lurbinectedin FDA label on DailyMed (effective February 27, 2026, Jazz Pharmaceuticals, Inc.); the NDA 213702 record on Drugs@FDA; every lurbinectedin label on DailyMed.
Highlights of the record
FDA label of February 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZEPZELCA is an alkylating drug indicated:
in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, for the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide.
Forms and strengths
- 0.5 mg/ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- June 15, 2020 Zepzelca, Jazz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 29, 2040 Zepzelca injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is lurbinectedin used for?
From the label: indications and usageZEPZELCA is an alkylating drug indicated:
in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, for the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. ( 1.1 )
For the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. ( 1.2 ) This indication is approved under accelerated approval based on overall response rate and duration of response. […]
Conditions named in the indications of lurbinectedin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (ZEPZELCA), Jazz Pharmaceuticals, Inc., effective February 27, 2026 (SPL set 632bb50c-3bcb-4c85-9056-fc33410550ae), via openFDA; the full label on DailyMed
What does the patient leaflet for lurbinectedin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using ZEPZELCA?Avoid eating or drinking grapefruit, Seville oranges, or products that contain grapefruit juice and Seville oranges during treatment with ZEPZELCA.
Source: FDA drug label (ZEPZELCA), Jazz Pharmaceuticals, Inc., effective February 27, 2026 (SPL set 632bb50c-3bcb-4c85-9056-fc33410550ae), via openFDA; the full label on DailyMed
Is there a generic for lurbinectedin (Zepzelca)?
No generic lurbinectedin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Zepzelca injection: the compound patent runs to December 13, 2029, and the last listed entry to May 29, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the lurbinectedin label say about other medicines?
The lurbinectedin label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atezolizumab | warnings and precautions | To reduce the risk of febrile neutropenia during treatment with ZEPZELCA in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, administer granulocyte colony-stimulating factor (G-CSF) [refer to Prescribing Information]. |
Source: FDA drug label (ZEPZELCA), Jazz Pharmaceuticals, Inc., effective February 27, 2026 (SPL set 632bb50c-3bcb-4c85-9056-fc33410550ae), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as lurbinectedin?
16 other medicines are given the same way (intravenous) and in the same FDA class as lurbinectedin or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Pemetrexed | Lung cancer | 15 labelers | n/a | A presentation being discontinued |
| Etoposide | Lung cancer | 5 labelers | n/a | No current entry |
| Topotecan | Lung cancer | 4 labelers | n/a | No current entry |
| Nivolumab | Lung cancer | none listed | n/a | No current entry |
| Atezolizumab | Lung cancer | none listed | n/a | No current entry |
| Durvalumab | Lung cancer | none listed | n/a | No current entry |
| Ipilimumab | Lung cancer | none listed | n/a | No current entry |
| Ramucirumab | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as lurbinectedin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to lurbinectedin
- 16 medicines for the same use
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other