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ZOLADEX

NDA

GOSERELIN ACETATE | N019726 | TERSERA THERAPEUTICS LLC

1 strength0 unique patents0 unique exclusivities

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer NCT05870579	Phase 1	Active	Novartis Pharmaceuticals	22	2023-11-13 → 2032-04-05
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.NCT07450599	Phase 2	Recruiting	Bayer	250	2026-04-27 → 2030-10-15

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

Medicare Part D Spending

CMS annual spending data for Zoladex (2023)

Total Spending

$711K

Total Claims

456

Beneficiaries

113

Avg Cost/Unit

$1532.04

Spending Trend

$855K(2019)→$852K(2020)→$880K(2021)→$849K(2022)→$711K(2023)

YoY Change:+8.4%

5yr CAGR:+5.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Zoladex (2023)

Total Spending

$10.5M

Total Claims

9,659

Beneficiaries

2,257

ASP Price

—

HCPCS: J9202 — Goserelin acetate implant, per 3.6 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain5 active DMFs1 inactive

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

ALP PHARM BEIJING CO LTDGOSERELIN ACETATE

DMF 297132015

ASTRAZENECA PHARMACEUTICALS LPGOSERELIN ACETATE

DMF 314882017

ASTRAZENECA PHARMACEUTICALS LPGOSERELIN ACETATE IMPLANT

DMF 314892017

BACHEM AGGOSERELIN ACETATE

DMF 343632019

BACHEM AGGOSERELIN ACETATE

DMF 356892024

CHEMI SPAInactiveGOSERELIN ACETATE

DMF 177682004

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

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
May 8, 2026	SUPPL -76	View Letter (PDF)
Sep 30, 2025	SUPPL -74	View Letter (PDF)
Mar 17, 2023	SUPPL -69	View Letter (PDF)
Jun 22, 2021	SUPPL -66	View Letter (PDF)
Feb 17, 2015	SUPPL -59	View Letter (PDF)
Oct 9, 2014	SUPPL -58	View Letter (PDF)
Jun 20, 2013	SUPPL -56	View Letter (PDF)
Jun 20, 2013	SUPPL -57	View Letter (PDF)
Jan 20, 2011	SUPPL -54	View Letter (PDF)
Jan 7, 2010	SUPPL -51	View Letter (PDF)
Jan 7, 2010	SUPPL -50	View Letter (PDF)
Jan 7, 2010	SUPPL -52	View Letter (PDF)
Oct 25, 2005	SUPPL -46	View Letter (PDF)
Jun 25, 2004	SUPPL -42	View Letter (PDF)
Feb 28, 2002	SUPPL -37	View Letter (PDF)
Feb 5, 2002	SUPPL -34	View Letter (PDF)
Jul 27, 1998	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 3.6MG BASE

RLD

0 patents0 exclusivities▴

IMPLANT;IMPLANTATION | Approved: Dec 29, 1989

No patent or exclusivity listings for this strength.