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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

217 trials from ClinicalTrials.gov — 15 recruiting, 27 active, 114 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors NCT04126070	Phase 2	Active	Xiao X. Wei, MD	47	2020-05-11 → 2026-10-30
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial NCT04513717	Phase 3	Active	NRG Oncology	2,753	2021-01-21 → 2038-12-31
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial NCT05050084	Phase 3	Active	NRG Oncology	2,050	2021-12-06 → 2031-11-11
PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer NCT01723774	Phase 2	Active	Washington University School of Medicine	84	2013-04-10 → 2026-08-24
Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy NCT04181203	Phase 3	Active	UNICANCER	490	2020-01-09 → 2033-12-28
Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer NCT00430183	Phase 3	Active	Alliance for Clinical Trials in Oncology	788	2007-05-08 → 2030-10
Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer NCT03361735	Phase 2	Active	City of Hope Medical Center	25	2018-08-29 → 2027-01-06
Roll-over Study to Allow Continued Access to Ribociclib NCT05161195	Phase 4	Active	Novartis Pharmaceuticals	134	2022-07-07 → 2030-08-14
Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations NCT05498272	Phase 2	Active	Rana McKay, MD	32	2023-02-01 → 2026-12
[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	28	2023-11-13 → 2032-04-27

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$374.64

Highest Price

$374.64

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70720-0950-36ZOLADEX 3.6MG INJ,IMPLANT	$374.64	Big4	TerSera Therapuetics, LLC	03/14/2029
70720-0950-36ZOLADEX 3.6MG INJ,IMPLANT	$374.64	FSS	TerSera Therapuetics, LLC	03/14/2029

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

Medicare Part D Spending

CMS annual spending data for Zoladex (2024)

Total Spending

$716K

Total Claims

466

Beneficiaries

105

Avg Cost/Unit

$1527.27

Spending Trend

$855K(2019)→$852K(2020)→$880K(2021)→$849K(2022)→$711K(2023)→$716K(2024)

YoY Change:-0.3%

5yr CAGR:+4.3%

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 Zoladex (2024)

Total Spending

$10.3M

Total Claims

8,842

Beneficiaries

2,048

ASP Price

$635.66

Spending Trend

$9.9M(2019)→$10.2M(2020)→$10.4M(2021)→$11.0M(2022)→$10.5M(2023)→$10.3M(2024)

YoY Change:+8.0%

5yr CAGR:+9.1%

HCPCS: J9202 — Goserelin acetate implant, per 3.6 mg

Source: CMS Medicare Part B Spending by Drug (2024). 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.