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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

66 trials from ClinicalTrials.gov — 4 recruiting, 35 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders NCT07861399	N/A	Recruiting	Al-Azhar University	100	2026-09-01 → 2028-10
Ovulation Trigger Strategies in Low Ovarian Reserve (TRIGGERBEST)NCT07816562	Phase 3	Recruiting	Fundación para la Investigación del Hospital Clínico de Valencia	126	2024-09-17 → 2028-01-01
Ultra-Long GnRH-a Pretreatment for FET Outcomes in Patients With Deep Infiltrating Endometriosis NCT07696351	Phase 4	Recruiting	Li-jun Ding	120	2025-08-01 → 2027-07-31
GnRH Agonist Pretreatment in Hysteroscopic Myomectomy NCT01873378	N/A	Completed	Azienda Ospedaliera S. Maria della Misericordia	84	2013-01 → 2015-08
GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Bolus of GnRHa at the Time of Implantation - a RCT NCT02053779	Phase 3	Completed	Centre Hospitalier Universitaire Ibn Rochd	328	2014-03 → 2017-03
Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg NCT01257425	Phase 2	Completed	Ipsen	109	2010-12 → 2012-05
MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism NCT02102646	Phase 4	Completed	Herlev Hospital	31	2014-04 → 2015-10
GnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles NCT00516490	N/A	Completed	V.K.V. American Hospital, Istanbul	570	2006-09 → 2007-07
Final Oocyte Maturation Via Administration of GnRH Agonists Followed By Luteal Support With hCG NCT01638026	Phase 4	Completed	HaEmek Medical Center, Israel	93	2012-09 → 2017-08

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

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.