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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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Xiromed, LLC. FDA-2025-P-1085 · 8 docket documents 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	Granted	Xiromed, LLC.

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

Clinical Trials

290 trials from ClinicalTrials.gov — 9 recruiting, 2 active, 223 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testosterone in Bariatric Patients NCT03721497	Phase 4	Active	Esbjerg Hospital - University Hospital of Southern Denmark	64	2020-12-17 → 2025-12
Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease NCT00080756	Phase 2	Active	City of Hope Medical Center	11	2004-03-11 → 2024-10-15
A Dose Ranging Study to Examine TDS-Testosterone 5%NCT01894308	Phase 2	Not Yet Recruiting	Transdermal Delivery Solutions Corp	48	2026-06 → 2027-02
Product Transference Study of Testagen™ TDS®-Testosterone NCT02733133	Phase 2	Not Yet Recruiting	Transdermal Delivery Solutions Corp	96	2027-01-05 → 2027-12
Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression NCT04363164	Phase 2	Recruiting	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	150	2020-08-19 → 2027-07
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer NCT00588185	N/A	Recruiting	Memorial Sloan Kettering Cancer Center	300	2003-02 → 2027-02
TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis NCT03910738	Phase 2	Recruiting	University Hospital, Strasbourg, France	40	2019-10-29 → 2027-12
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency NCT04301765	Phase 2	Recruiting	Seattle Institute for Biomedical and Clinical Research	230	2021-01-12 → 2026-11-01
Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone NCT04049331	Phase 2	Recruiting	Seattle Institute for Biomedical and Clinical Research	240	2021-03-22 → 2027-01-30
Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism NCT03851627	Phase 4	Recruiting	Alexandra Kautzky-Willer	32	2022-01-25 → 2028-12

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

API Supply Chain4 active DMFs4 inactive

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

BAYER AGTESTOSTERONE ENANTHATE

DMF 33911978

ASPEN OSS BVTESTOSTERONE ENANTHATE

DMF 38771980

SYMBIOTEC PHARMALAB PRIVATE LTDTESTOSTERONE ENANTHATE, USP

DMF 261662012

STEROID SPATESTOSTERONE ENANTHATE

DMF 327652018

ROUSSELL UCLAFInactiveTESTOSTERONE ENANTHATE

DMF 37811980

PHARMACIA AND UPJOHNInactiveTESTOSTERONE ENANTHATE USP

DMF 42391981

BIOVET JOINT STOCK COInactiveTESTOSTERONE ENANTHATE

DMF 239202010

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDInactiveTESTOSTERONE ENANTHATE, NON-STERILE BULK DRUG SUBSTANCE

DMF 274312013

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