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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

7 trials from ClinicalTrials.gov — 1 recruiting, 4 active, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)NCT06129539	Phase 3	Active	Debiopharm International SA	56	2024-07-31 → 2028-02
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 → 2033-12-31
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 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 → 2026-11-11
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 NCT05879926	Phase 3	Recruiting	NRG Oncology	3,960	2023-10-18 → 2034-07
High-Dose Brachytherapy in Treating Patients With Prostate Cancer NCT02346253	N/A	Completed	Stanford University	146	2015-01-13 → 2026-05-17
Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.NCT06134479	Phase 3	Completed	Fundación Santiago Dexeus Font	194	2023-12-18 → 2025-09-09

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

Medicare Part D Spending

CMS annual spending data for Trelstar (2023)

Total Spending

$14.2M

Total Claims

5,660

Beneficiaries

2,074

Avg Cost/Unit

$2514.33

Spending Trend

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

YoY Change:+7.7%

5yr CAGR:+2.4%

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 Trelstar (2023)

Total Spending

$10.0M

Total Claims

8,342

Beneficiaries

3,303

ASP Price

—

HCPCS: J3315 — Injection, triptorelin pamoate, 3.75 mg

Source: CMS Medicare Part B Spending by Drug (2023). 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.