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DECA-DURABOLIN

NDA

NANDROLONE DECANOATE | N013132 | WOODWARD SPECIALTY LLC

3 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
PharmaForce - Citizen Petition FDA-2009-P-0218 · 5 docket documents PharmaForce, Inc. filed this citizen petition pursuant to 21 CFR 10.30 and 21 CFR 314.161, requesting that the FDA determine whether Deca-Durabolin Injection, 200 mg/mL (NDA No. 13-132), manufactured by Organon USA Inc., was voluntarily withdrawn from sale for safety or effectiveness reasons. The pe	Other	2009-05-13	Denied	—

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

Clinical Trials

10 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders NCT00000597	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1982-03 → 1988-12
Anabolic Steroids and Exercise in Hemodialysis Patients NCT00250536	N/A	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	80	2000-03 → 2004-10
Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture.NCT03545347	Phase 2	Completed	Morten Tange Kristensen PT, PhD	29	2018-09-03 → 2020-06-03
A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss NCT00000854	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	38	— → 2003-05
Impact of the Use of Nandrolone on the Treatment of Malnutrition Induced by Cancer NCT03263520	N/A	Completed	Hospital Erasto Gaertner	60	2016-02 → 2017-10-31
The Effect of Nandrolone Decanoate and Leucine on Muscle Loss NCT02376309	N/A	Completed	Maastricht University Medical Center	30	2015-08 → 2017-08
Nandrolone Decanoate in the Treatment of Telomeropathies NCT02055456	Phase 1/2	Completed	University of Sao Paulo	20	2014-02-01 → 2017-02-01
Assessment of Mechanisms of Improved Wound Healing NCT00673309	Phase 2/3	Completed	The University of Texas Medical Branch, Galveston	644	2000-07 → 2013-04
Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation NCT00675714	Phase 2/3	Terminated	The University of Texas Medical Branch, Galveston	1,126	2004-01 → 2019-07-15
Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients NCT00242463	Phase 2	Terminated	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	20	2005-10 → 2007-10

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

API Supply Chain1 active DMF5 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ASPEN OSS BVNANDROLONE DECANOATE

DMF 217622008

ORMA ISTITUDO TERAPEUTICOInactiveNANDROLONE DECANOATE

DMF 32291978

GEDEON RICHTER LTDInactiveNANDROLONE DECANOATE

DMF 35031979

SCHERING AGInactiveNANDROLONE DECANOATE

DMF 41021981

STEROID SRLInactiveNANDROLONE DECANOATE (USAN)

DMF 42281981

RELIANCE LIFE SCIENCES PVT LTDInactiveNANDROLONE DECANOATE USP

DMF 248832011

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

Products (3)

Sort:

#001 — 50MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 12, 1986

No patent or exclusivity listings for this strength.

#002 — 100MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 12, 1986

#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: Jun 12, 1986