Viewing data from:

FORTESTA

NDA

TESTOSTERONE | N021463 | ENDO OPERATIONS LTD

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Endo Pharmaceuticals Inc et al v. Watson Laboratories Inc 2:2013cv00192 2 patentsANDA 204571testosterone gel for topical use	E.D. Tex.	2013-02-28	Terminated 2015-10-22	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Encube Ethicals Private Limited FDA-2024-P-2515 · 5 docket documents Encube Ethicals Private Limited submitted a citizen petition on May 22, 2024, requesting that the FDA determine whether Fortesta (testosterone) 10 mg/0.5 gm Actuation Gel (NDA 021463), held by Endo Operations Ltd and listed in the Orange Book's discontinued section, was withdrawn for reasons of safe	505(q)	2024-05-23	Denied	Encube Ethicals Private Limited

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 Chain13 active DMFs12 inactive

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

PHARMACIA AND UPJOHN SUB PFIZER INCTESTOSTERONE, USP

DMF 31901978

ASPEN OSS BVTESTOSTERONE

DMF 118261996

BAYER AGTESTOSTERONE

DMF 150772000

BAYER AGTESTOSTERONE UNDECANOATE 750 MG I.M.

DMF 168092003

DR REDDYS LABORATORIES LTDTESTOSTERONE

DMF 236712010

SUN PHARMACEUTICAL INDUSTRIES LTDTESTOSTERONE USP

DMF 274472013

SYMBIOTEC PHARMALAB PRIVATE LTDTESTOSTERONE USP (MICRONIZED)

DMF 298692015

LUPIN LTDTESTOSTERONE USP

DMF 303772016

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTESTOSTERONE CYPIONATE NON- STERILE, BULK DRUG SUBSTANCE

DMF 307412016

CURIA SPAIN SAUTESTOSTERONE MICRONIZED

DMF 328172018

HUBEI GOTO BIOTECHNOLOGY CO LTDTESTOSTERONE

DMF 331182018

HUBEI ZHUXI HUMANWELL PHARMACEUTICAL CO LTDTESTOSTERONE

DMF 370742022

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTESTOSTERONE TRIDECANOATE

DMF 378902023

F.X. GASSNER, COLORADO STATE UNIVERSITYInactiveTESTOSTERONE & DIETHYLSTILBESTROL-CATTLE FEED MIXED W/INGREDS--SAFETY?

DMF 2741940

DIOSYNTH BVInactiveTESTOSTERONE

DMF 39741980

ROUSSELL UCLAFInactiveTESTOSTERONE (DIOSYNTH BV)

DMF 45121982

SCHERING AGInactiveTESTOSTERONE

DMF 46951982

MEDISORB TECHNOLOGIES INTERNATIONAL LTD PARTNERSHIPInactiveTESTOSTERONE INJECTABLE MICROSPHERES

DMF 75021988

SIGMA F AND D DIV LTDInactiveTESTOSTERONE

DMF 99311992

ARDANA BIOSCIENCE LTDInactiveTESTOSTERONE CREAM 1% (ARD-0403)

DMF 193492006

CIPLA LTDInactiveTESTOSTERONE USP

DMF 215462008

BIOVET JOINT STOCK COInactiveTESTOSTERONE

DMF 231572009

PRODUCTOS QUIMICOS NATURALES SA DE CV PROQUINAInactiveTESTOSTERONE L-2

DMF 243102010

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDInactiveTESTOSTERONE PROPIONATE NON-STERILE BULK DRUG SUBSTANCE

DMF 256062011

INDO PHYTO CHEMICALS PRIVATE LTDInactiveTESTOSTERONE USP

DMF 264302012

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Jul 15, 2025	SUPPL -29	View Letter (PDF)
Jul 1, 2020	SUPPL -25	View Letter (PDF)
Mar 17, 2020	SUPPL -22	View Letter (PDF)
Jun 3, 2019	SUPPL -21	View Letter (PDF)
May 13, 2019	SUPPL -20	View Letter (PDF)
Oct 27, 2016	SUPPL -19	View Letter (PDF)
May 13, 2015	SUPPL -17	View Letter (PDF)
Aug 1, 2014	SUPPL -15	View Letter (PDF)
Jun 23, 2014	SUPPL -14	View Letter (PDF)
Mar 25, 2014	SUPPL -12	View Letter (PDF)
Sep 11, 2013	SUPPL -10	View Letter (PDF)
Jan 7, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/0.5GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

GEL, METERED;TRANSDERMAL | Approved: Dec 29, 2010

No patent or exclusivity listings for this strength.