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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

196 trials from ClinicalTrials.gov — 5 recruiting, 18 active, 112 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial NCT02624973	Phase 2	Active	Haukeland University Hospital	200	2016-04-15 → 2030-06
Management of Castration-Resistant Prostate Cancer with Oligometastases NCT02685397	Phase 2/3	Active	Sir Mortimer B. Davis - Jewish General Hospital	102	2016-10 → 2041-08
Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases NCT02603679	Phase 2	Active	Thomas Hatschek	181	2015-02 → 2031-12-31
Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer NCT01786265	Phase 2	Active	M.D. Anderson Cancer Center	310	2013-02-05 → 2027-02-01
Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer NCT02023463	Phase 1	Active	Thomas Jefferson University	25	2014-04-02 → 2040-01-01
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors NCT04126070	Phase 2	Active	Xiao X. Wei, MD	47	2020-05-11 → 2026-06-30
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer NCT00544830	Phase 2	Active	City of Hope Medical Center	29	2006-07-18 → 2027-02-15
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
A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery NCT03809000	Phase 2	Active	RTOG Foundation, Inc.	188	2019-04-15 → 2029-09-15
Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors NCT02592083	Phase 2	Active	Thomas Hatschek	10	2015-10 → 2029-02

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

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	FSS	TerSera Therapuetics, LLC	03/14/2029
70720-0950-36ZOLADEX 3.6MG INJ,IMPLANT	$374.64	Big4	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.