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ZEPZELCA

NDA

LURBINECTEDIN | N213702 | JAZZ PHARMACEUTICALS IRELAND LTD

1 strength5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

Dec. 13, 2029

May. 29, 2040

May. 29, 2040

May. 29, 2040

May. 29, 2040

ODE-304

Jun. 15, 2027

I-977

Oct. 2, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
JAZZ PHARMACEUTICALS IRELAND LIMITED et al v. INVAGEN PHARMACEUTICALS, INC. et al 3:2025cv15276 1 patentANDA 219605, 219515, 219582, 219731, 219771lurbinectedin	D.N.J.	2025-09-04	Active	—
Jazz Pharmaceuticals Ireland Limited et al v. InvaGen Pharmaceuticals, Inc. et al 2:2024cv06416	E.D.N.Y.	2024-09-12	Terminated 2024-10-17	—
JAZZ PHARMACEUTICALS IRELAND LIMITED et al v. SANDOZ, INC. et al 3:2024cv09110 1 patentANDA 219515, 219605, 219582, 219731, 219771lurbinectedin	D.N.J.	2024-09-11	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

35 trials from ClinicalTrials.gov — 15 recruiting, 3 active, 15 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer NCT04607954	Phase 2	Active	Mayo Clinic	29	2020-12-04 → 2030-09-02
Lurbinectedin + Doxorubicin In Leiomyosarcoma NCT05099666	Phase 1/2	Active	Massachusetts General Hospital	62	2022-02-04 → 2028-07
A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer NCT05091567	Phase 3	Active	Hoffmann-La Roche	660	2021-11-18 → 2028-02-28
Lurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung Cancer NCT07640932	Phase 2	Not Yet Recruiting	Yonsei University	69	2026-11 → 2029-02
A Study of ZL-1310 in Combination With a Checkpoint Inhibitor Versus Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer NCT07796100	Phase 3	Not Yet Recruiting	Zai Lab (Shanghai) Co., Ltd.	530	2026-12-31 → 2031-06-30
A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer NCT07155174	Phase 2	Recruiting	AbbVie	180	2025-11-25 → 2031-09
Clinical Study in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT) ISG-TULIPS NCT07328425	Phase 2	Recruiting	Italian Sarcoma Group	20	2025-11-21 → 2030-10-01
Lurbinectedin in FET-Fused Tumors NCT05918640	Phase 1/2	Recruiting	Children's Hospital of Philadelphia	63	2023-07-27 → 2029-07-30
A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer NCT06203210	Phase 3	Recruiting	Daiichi Sankyo	540	2024-05-21 → 2029-12-01
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 NCT07365241	Phase 3	Recruiting	AbbVie	531	2026-07-02 → 2030-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$5414.00

Highest Price

$5414.00

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
68727-0712-01ZEPZELCA	$5414.00	FSS	Jazz Pharmaceuticals, Inc.	09/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Zepzelca (2024)

Total Spending

$2.6M

Total Claims

169

Beneficiaries

Avg Cost/Unit

$7907.59

Spending Trend

$372K(2020)→$1.2M(2021)→$1.6M(2022)→$2.4M(2023)→$2.6M(2024)

YoY Change:-4.5%

5yr CAGR:+3.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Zepzelca (2024)

Total Spending

$114.9M

Total Claims

7,712

Beneficiaries

1,956

ASP Price

$201.47

Spending Trend

$88.3M(2021)→$91.8M(2022)→$105.3M(2023)→$114.9M(2024)

YoY Change:+5.1%

5yr CAGR:+4.2%

HCPCS: J9223 — Injection, lurbinectedin, 0.1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain7 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

PHARMA MAR SALURBINECTEDIN

DMF 339692019

WISDOM PHARMACEUTICAL CO LTDLURBINECTEDIN

DMF 376242023

NATCO PHARMA LTDLURBINECTEDIN

DMF 377852024

APICORE LLCLURBINECTEDIN

DMF 391712024

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDLURBINECTEDIN

DMF 392282023

XILING LAB CO LTDLURBINECTEDIN

DMF 396202024

MSN LABORATORIES PRIVATE LTDLURBINECTEDIN

DMF 396722024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Oct 1, 2026	SUPPL -13	View Letter (PDF)
Mar 3, 2026	SUPPL -12	View Letter (PDF)
Oct 3, 2025	SUPPL -11	View Letter (PDF)
May 5, 2025	SUPPL -10	View Letter (PDF)
Jul 31, 2023	SUPPL -8	View Letter (PDF)
Apr 4, 2022	SUPPL -4	View Letter (PDF)
Jun 16, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4MG/VIAL

RLD

5 patents2 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jun 15, 2020

Patents (5) · 6 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
7763615	Dec 13, 2029	—	Yes	Yes	—
12324806	May 29, 2040	—	—	—	—
12433890	May 29, 2040	—	—	—	—
12440490	May 29, 2040	—	—	—	—
12746240Newly listed — daily FDA feed, not yet in monthly Orange Book edition	May 29, 2040	—	—	—	—

Exclusivities (2)

Code	Date	Status
I-977	Oct 2, 2028	Active
ODE-304	Jun 15, 2027	< 1 year