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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Fortesta (2023)

Total Spending

$20K

Total Claims

Beneficiaries

Avg Cost/Unit

$6.64

Spending Trend

$190K(2019)→$142K(2020)→$99K(2021)→$67K(2022)→$20K(2023)

YoY Change:-5.8%

5yr CAGR:-0.8%

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

API Supply Chain15 active DMFs13 inactive

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

ASPEN OSS BVTESTOSTERONE

DMF 118261996

BAYER AGTESTOSTERONE

DMF 150772000

BAYER AGTESTOSTERONE UNDECANOATE 750 MG I.M.

DMF 168092003

DR REDDYS LABORATORIES LTDTESTOSTERONE

DMF 236712010

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

DMF 239342010

SYMBIOTEC PHARMALAB PRIVATE LTDTESTOSTERONE PROPIONATE, USP (MICRONIZED)

DMF 255352011

SYMBIOTEC PHARMALAB PRIVATE LTDTESTOSTERONE ENANTHATE, USP

DMF 261662012

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

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

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.