Testosterone

Sold as Testoderm, Androderm, Testoderm Tts, Androgel, Testim and 6 more. Every FDA application for this active ingredient: 13 branded and 27 generic.

As of Nov 14, 2026, FDA lists 40 applications for Testosterone (sold as Testoderm, Androderm, Testoderm Tts and others), first approved Oct 12, 1993, with 2 new uses approved and 0 published complete response letters.

First approved: Oct 12, 1993
Applications: 40
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $96.2M
First approved in the EU: Jul 28, 2006

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Testosterone	Part D	$93.9M	+0%	149,493
Testopel	Part D	$1.2M	-3%	495
Testim	Part D	$941K	-3%	229
Androgel	Part D	$115K	-97%	70
Androderm	Part D	$0K	-100%	0
Natesto	Part D	$0K	-100%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

TESTOSTERONE 1.62% (2.5 G) PKT: $1.77 per GMGeneric · -21% in a year
TESTOSTERONE 1.62% GEL PUMP: $0.471 per GMGeneric · +9% in a year
TESTOSTERONE 1.62%(1.25 G) PKT: $4.08 per GMGeneric · +18% in a year
TESTOSTERONE 1% (25 MG/2.5 G) PK: $1.11 per GMGeneric · -44% in a year
TESTOSTERONE 1% (50 MG/5 G) PK: $0.433 per GMGeneric · -22% in a year
TESTOSTERONE 10 MG GEL PUMP: $4.55 per GMGeneric · +0% in a year
TESTOSTERONE 12.5 MG/1.25 GRAM: $0.805 per GMGeneric · -16% in a year
TESTOSTERONE 30 MG/1.5 ML PUMP: $0.543 per MLGeneric · -27% in a year
TESTOSTERONE 50 MG/5 GRAM GEL: $0.769 per GMGeneric · +1% in a year
TESTOSTERONE 50 MG/5 GRAM PKT: $0.433 per GMGeneric · -22% in a year
TESTIM 1% (50 MG) GEL: $3.78 per GMBrand · +0% in a year

Orphan Designations (FDA)

3 designations, 0 approved for the designated use; see all orphan designations

Treatment of Duchenne Muscular DystrophySarcomed AB · designated Jan 12, 2022
For use as physiologic testosterone replacement in androgen deficient HIV+ patients with an associated weight loss.Watson Laboratories · designated Sep 22, 1997
Treatment of weight loss in AIDS patients with HIV-associated wasting.Unimed Pharmaceuticals, Inc. · designated Feb 5, 1996

Approvals in the EU (EMA)

First approved in the EU 153 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Intrinsa, new substanceWarner Chilcott UK Ltd. · Jul 28, 2006 · withdrawn
LivensaWarner Chilcott Deutschland GmbH · Jul 28, 2006 · withdrawn

Clinical Trials

165 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Exercise Self-Efficacy, Body Composition, and Physical Activity in Men With HypogonadismHypogonadism, Male, Body Composition · Hacettepe University	—	Recruiting	Nov 9, 2026
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular BundleProstate Cancer, Localized Prostate Carcinoma · University of Zurich	Not applicable	Not yet recruiting	Nov 4, 2026
Effects of Probiotic Supplementation on Androgen LevelsAndrogen Levels · National Taiwan University Hospital	Not applicable	Recruiting	Nov 3, 2026
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability PilotVestibulodynia, Vulvodynia · HerAccess ApS	Not applicable	Not yet recruiting	Nov 2, 2026
Testosterone-Informed De-Escalation in Metastatic Prostate Cancer (TIDE PC)Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) · University of Nebraska	Phase 2	Not yet recruiting	Oct 29, 2026
Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With HypogonadismMale Hypogonadism · Amneal Pharmaceuticals, LLC	Phase 3	Recruiting	Oct 27, 2026
HRT-PC Trial: Hormone Recovery After Treatment for Prostate Cancer Trial. An Open-label Phase II Study of Clomiphene Citrate in Patients With Persistent Hypogonadism After ADT for Treatment of Localized Prostate CancerProstate Cancer · University of Nebraska	Phase 2	Not yet recruiting	Oct 20, 2026
Validation of Uzbek-Language ADAM, AMS, and IPSS Questionnaires in Men Aged 35-59 YearsPsychometric Validation of Men's Health Questionnaires · Andijan State Medical Institute	—	Recruiting	Oct 16, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jul 13, 1972	TestopelANDA 80911	Endo Operations	14	Marketed
May 10, 1983	TestosteroneANDA 86420	Watson Labs	2	Discontinued
Jul 7, 1983	TestosteroneANDA 86417	Dr Reddys	17	Discontinued
Aug 23, 1983	TestosteroneANDA 86419	Watson Labs	3	Discontinued
Oct 12, 1993	TestodermNDA 19762 · New dosage form	Alza	4	Discontinued
Sep 29, 1995	AndrodermNDA 20489 · New dosage form	Abbvie	20	Discontinued
Dec 18, 1997	Testoderm TtsNDA 20791 · New dosage form	Alza	1	Discontinued
Feb 28, 2000	AndrogelNDA 21015 · New dosage form	Besins Hlthcare	33	Marketed
Oct 31, 2002	TestimNDA 21454 · New dosage form	Endo Operations	16	Marketed
Jun 19, 2003	StriantNDA 21543 · New dosage form	Auxilium Pharms LLC	6	Discontinued
Jan 27, 2006	TestosteroneANDA 76737	Actavis Labs Ut Inc	4	Marketed
May 23, 2007	TestosteroneANDA 76744	Strides Pharma Intl	9	Marketed
Nov 23, 2010	AxironNDA 22504 · New dosage form	Eli Lilly And Co	11	Discontinued
Dec 29, 2010	FortestaNDA 21463 · New dosage form	Endo Operations	15	Discontinued
Apr 29, 2011	AndrogelNDA 22309 · New dosage form	Besins Hlthcare	16	Marketed
Feb 14, 2012	TestosteroneNDA 202763 · New dosage form	Ani Pharms	4	Discontinued
Jan 31, 2013	TestosteroneNDA 203098 · New dosage form	Perrigo Israel	6	Discontinued
May 28, 2014	NatestoNDA 205488 · New formulation or manufacturer	Acerus	3	Marketed
Jun 4, 2014	VogelxoNDA 204399 · New formulation or manufacturer	Upsher Smith Labs	7	Marketed
Aug 4, 2015	TestosteroneANDA 204268	Padagis Israel	1	Marketed
Aug 5, 2015	TestosteroneANDA 204571	Actavis Labs Ut Inc	4	Marketed
Feb 28, 2017	TestosteroneANDA 204255	Padagis Israel	5	Marketed
Jul 12, 2017	TestosteroneANDA 205781	Padagis Israel	1	Marketed
Aug 7, 2017	TestosteroneANDA 205328	Actavis Labs Ut Inc	3	Marketed
Sep 18, 2017	TestosteroneANDA 91073	Actavis Labs Ut Inc	3	Marketed
Oct 23, 2017	TestosteroneANDA 208061	Lupin	4	Marketed
Jan 29, 2018	TestosteroneANDA 209533	Cipla	3	Marketed
Apr 10, 2019	TestosteroneANDA 204570	Actavis Labs Ut Inc	2	Marketed
Apr 10, 2019	TestosteroneANDA 207373	Amneal	1	Marketed
Apr 10, 2019	TestosteroneANDA 208560	Lupin	1	Marketed
Apr 10, 2019	TestosteroneANDA 208620	Encube	3	Marketed
Sep 23, 2019	TestosteroneANDA 209390	Twi Pharms	1	Discontinued
Apr 16, 2020	TestosteroneANDA 210835	Xiromed	0	Marketed
Nov 25, 2020	TestosteroneANDA 209181	Apotex	1	Discontinued
Jan 11, 2021	TestosteroneANDA 212301	Encube	1	Marketed
Mar 3, 2021	TestosteroneANDA 213922	Alembic	0	Discontinued
Jun 14, 2021	TestosteroneANDA 212882	Alembic	1	Discontinued
Sep 3, 2021	TestosteroneANDA 209836	Twi Pharms	1	Discontinued
Nov 9, 2021	TestosteroneANDA 212984	Encube	1	Marketed
—	TestosteroneANDA 207337	Sandoz Inc	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA