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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

100 trials from ClinicalTrials.gov — 5 recruiting, 8 active, 52 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Hypo-Combi Trial: Hypofractionated EBRT Plus HDR-BT Boost for Prostate Cancer NCT05003752	Phase 1/2	Active	German Oncology Center, Cyprus	40	2021-08-01 → 2027-08-01
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer NCT05607004	Phase 2	Active	Atossa Therapeutics, Inc.	87	2023-02-14 → 2027-04
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 → 2027-11-07
Androgen Deprivation Therapy (ADT) and Pembrolizumab for Advanced Stage Androgen Receptor-positive Salivary Gland Carcinoma NCT03942653	Phase 2	Active	Manish Patel	20	2019-05-30 → 2026-08
Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic NCT02115282	Phase 3	Active	National Cancer Institute (NCI)	608	2014-03-29 → 2027-06-02
Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone NCT00223145	Phase 3	Active	Abdenour Nabid	600	2000-12 → 2027-12-31
Effect of a GnRH Analog on Hepatic Steatosis NCT06523530	Phase 4	Active	Aristotle University Of Thessaloniki	62	2024-11-26 → 2027-10
[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 → 2032-05-27
QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant Chemotherapy NCT07782840	Phase 2	Not Yet Recruiting	Hebei Medical University Fourth Hospital	40	2026-10-01 → 2028-12-01
Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)NCT06582446	Phase 2	Recruiting	German Oncology Center, Cyprus	30	2024-09-16 → 2027-08-31

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	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.