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TRELSTAR

NDA

TRIPTORELIN PAMOATE | N020715 | VERITY PHARMACEUTICALS INC

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

108 trials from ClinicalTrials.gov — 9 recruiting, 7 active, 50 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study NCT04484818	Phase 3	Active	ECOG-ACRIN Cancer Research Group	27	2021-03-01 → 2028-05-31
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
FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer NCT03944434	Phase 2	Active	Fondazione Sandro Pitigliani	116	2018-12-27 → 2025-11-27
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
Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy NCT04181203	Phase 3	Active	UNICANCER	490	2020-01-09 → 2033-12-28
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
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
Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer NCT07751133	Phase 3	Not Yet Recruiting	University College, London	1,500	2026-08-03 → 2033-08-01
Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer NCT06513962	Phase 3	Recruiting	Children's Oncology Group	60	2025-02-27 → 2029-10-30

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

$345.72

Highest Price

$619.81

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
74676-5902-01TRELSTAR 3.75MG KIT	$345.72	Big4	Verity Pharmaceuticals Inc.	11/30/2026
74676-5902-01TRELSTAR 3.75MG KIT	$619.81	FSS	Verity Pharmaceuticals Inc.	11/30/2026

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

Medicare Part D Spending

CMS annual spending data for Trelstar (2024)

Total Spending

$15.3M

Total Claims

6,223

Beneficiaries

2,414

Avg Cost/Unit

$2463.15

Spending Trend

$10.9M(2021)→$14.7M(2022)→$14.2M(2023)→$15.3M(2024)

YoY Change:-2.0%

5yr CAGR:+0.9%

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 Trelstar (2024)

Total Spending

$11.4M

Total Claims

7,918

Beneficiaries

3,298

ASP Price

$438.88

Spending Trend

$9.5M(2019)→$11.3M(2020)→$23.8M(2021)→$12.3M(2022)→$10.0M(2023)→$11.4M(2024)

YoY Change:+17.0%

5yr CAGR:+11.4%

HCPCS: J3315 — Injection, triptorelin pamoate, 3.75 mg

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

API Supply Chain3 active DMFs

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

BACHEM AGTRIPTORELIN PAMOATE

DMF 62911986

DEBIOPHARM RESEARCH AND MANUFACTURING SATRIPTORELIN PAMOATE MICROGRANULES

DMF 303642016

HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDTRIPTORELIN

DMF 399312024

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

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Jun 30, 2026	SUPPL -52	View Letter (PDF)
Sep 25, 2025	SUPPL -51	View Letter (PDF)
Mar 13, 2025	SUPPL -50	View Letter (PDF)
Apr 15, 2024	SUPPL -49	View Letter (PDF)
Nov 20, 2023	SUPPL -47	View Letter (PDF)
Mar 6, 2023	SUPPL -45	View Letter (PDF)
Dec 21, 2018	SUPPL -40	View Letter (PDF)
Jul 15, 2014	SUPPL -32	View Letter (PDF)
Mar 15, 2013	SUPPL -30	View Letter (PDF)
May 24, 2011	SUPPL -25	View Letter (PDF)
Jan 20, 2011	SUPPL -24	View Letter (PDF)
Apr 16, 2008	SUPPL -16	View Letter (PDF)
Oct 25, 2005	SUPPL -6	View Letter (PDF)
Jan 15, 2002	SUPPL -3	View Letter (PDF)
Jan 15, 2002	SUPPL -4	View Letter (PDF)
Jun 15, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 3.75MG BASE/VIAL

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRAMUSCULAR | Approved: Jun 15, 2000

No patent or exclusivity listings for this strength.