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DELATESTRYL

NDA

TESTOSTERONE ENANTHATE | N009165 | ENDO PHARMACEUTICALS INC

2 strengths0 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Xiromed, LLC. FDA-2025-P-1085 Xiromed Pharma Espana SL filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that FDA declare Testosterone Enanthate Injection, USP 400 mg/2 mL (200 mg/mL) as a pre-filled syringe suitable for submission as an ANDA,	Suitability	2025-04-15	Open	Xiromed

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Xyosted (2023)

Total Spending

$22.2M

Total Claims

27,535

Beneficiaries

5,120

Avg Cost/Unit

$313.62

Spending Trend

$2.4M(2019)→$6.8M(2020)→$10.8M(2021)→$14.8M(2022)→$22.2M(2023)

YoY Change:+8.0%

5yr CAGR:+6.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs3 inactive

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

BAYER AGTESTOSTERONE ENANTHATE

DMF 33911978

ASPEN OSS BVTESTOSTERONE ENANTHATE

DMF 38771980

STEROID SPATESTOSTERONE ENANTHATE

DMF 327652018

ROUSSELL UCLAFInactiveTESTOSTERONE ENANTHATE

DMF 37811980

PHARMACIA AND UPJOHNInactiveTESTOSTERONE ENANTHATE USP

DMF 42391981

BIOVET JOINT STOCK COInactiveTESTOSTERONE ENANTHATE

DMF 239202010

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Oct 27, 2016	SUPPL -34	View Letter (PDF)
May 13, 2015	SUPPL -33	View Letter (PDF)
Jun 23, 2014	SUPPL -32	View Letter (PDF)
Jul 30, 2007	SUPPL -31	View Letter (PDF)
Mar 15, 2007	SUPPL -30	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982