FDA Orange Book · active-ingredient family
Testosterone
Testosterone: 13 brands, 26 generics; first approved May 10, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 26 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
13
Generics (ANDA)
26
Listed patents
19
Next patent expiry
Jun 02, 2026
3 mo ago
Brand (NDA) products
Originator applications
- ACERUSNDA 2054882014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5.5MG/0.122GM ACTUATION GEL, METERED NASAL Rx — - ANDRODERMRLDABBVIENDA 02048920114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/24HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued — 5MG/24HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued — 2MG/24HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued — 4MG/24HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued — - BESINS HLTHCARENDA 02230920113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED TRANSDERMAL Rx AB 1.62% (20.25MG/1.25GM PACKET) GEL TRANSDERMAL Rx AB2 1.62% (40.5MG/2.5GM PACKET) GEL TRANSDERMAL Rx AB2 - FORTESTARLDENDO OPERATIONSNDA 0214632010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/0.5GM ACTUATION GEL, METERED TRANSDERMAL Discontinued — - AXIRONRLDELI LILLY AND CONDA 0225042010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/1.5ML ACTUATION SOLUTION, METERED TRANSDERMAL Discontinued — - ANDROGELRLDBESINS HLTHCARENDA 02101520033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/2.5GM PACKET GEL TRANSDERMAL Rx AB1 50MG/5GM PACKET GEL TRANSDERMAL Rx AB1 12.5MG/1.25GM ACTUATION GEL, METERED TRANSDERMAL Rx AB1 - STRIANTRLDAUXILIUM PHARMS LLCNDA 0215432003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG TABLET, EXTENDED RELEASE BUCCAL Discontinued — - ENDO OPERATIONSNDA 0214542002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5GM PACKET GEL TRANSDERMAL Rx AB2 - UPSHER SMITH LABSNDA 20439920142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5GM PACKET GEL TRANSDERMAL Rx AB2 12.5MG/1.25GM ACTUATION GEL, METERED TRANSDERMAL Rx BX - TESTOSTERONEPERRIGO ISRAELNDA 20309820133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG/1.25GM ACTUATION GEL, METERED TRANSDERMAL Discontinued — 25MG/2.5GM PACKET GEL TRANSDERMAL Discontinued — 50MG/5GM PACKET GEL TRANSDERMAL Discontinued — - TESTOSTERONEANI PHARMSNDA 20276320122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/2.5GM PACKET GEL TRANSDERMAL Discontinued — 50MG/5GM PACKET GEL TRANSDERMAL Discontinued — - ALZANDA 0207911997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/24HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued — - ALZANDA 01976219932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG/24HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued — 6MG/24HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued —
Generic (ANDA) products (26)
Abbreviated applications
- TESTOSTERONEENCUBEANDA 21298420243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5GM PACKET GEL TRANSDERMAL Rx AB1 12.5MG/1.25GM ACTUATION GEL, METERED TRANSDERMAL Rx AB1 25MG/2.5GM PACKET GEL TRANSDERMAL Rx AB1 - TESTOSTERONETWI PHARMSANDA 2098362021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/1.5ML ACTUATION SOLUTION, METERED TRANSDERMAL Discontinued — - TESTOSTERONEALEMBICANDA 2128822021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/1.5ML ACTUATION SOLUTION, METERED TRANSDERMAL Discontinued — - TESTOSTERONEALEMBICANDA 2139222021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED TRANSDERMAL Discontinued — - TESTOSTERONEENCUBEANDA 2123012021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/1.5ML ACTUATION SOLUTION, METERED TRANSDERMAL Rx AT - TESTOSTERONEAPOTEXANDA 2091812020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/1.5ML ACTUATION SOLUTION, METERED TRANSDERMAL Discontinued — - TESTOSTERONEXIROMEDANDA 2108352020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED TRANSDERMAL Rx AB - TESTOSTERONETWI PHARMSANDA 2093902019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED TRANSDERMAL Discontinued — - TESTOSTERONEACTAVIS LABS UT INCANDA 20457020193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED TRANSDERMAL Rx AB 1.62% (20.25MG/1.25GM PACKET) GEL TRANSDERMAL Rx AB2 1.62% (40.5MG/2.5GM PACKET) GEL TRANSDERMAL Rx AB2 - TESTOSTERONEAMNEALANDA 2073732019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED TRANSDERMAL Rx AB - TESTOSTERONEENCUBEANDA 2086202019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED TRANSDERMAL Rx AB - TESTOSTERONELUPINANDA 2085602019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED TRANSDERMAL Rx AB - TESTOSTERONECIPLAANDA 2095332018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/1.5ML ACTUATION SOLUTION, METERED TRANSDERMAL Rx AT - TESTOSTERONELUPINANDA 2080612017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/1.5ML ACTUATION SOLUTION, METERED TRANSDERMAL Rx AT - TESTOSTERONEACTAVIS LABS UT INCANDA 0910732017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5GM PACKET GEL TRANSDERMAL Rx AB2 - TESTOSTERONEACTAVIS LABS UT INCANDA 2053282017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/1.5ML ACTUATION SOLUTION, METERED TRANSDERMAL Rx AT - TESTOSTERONEPADAGIS ISRAELANDA 20578120172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.62% (20.25MG/1.25GM PACKET) GEL TRANSDERMAL Rx AB2 1.62% (40.5MG/2.5GM PACKET) GEL TRANSDERMAL Rx AB2 - TESTOSTERONERSPADAGIS ISRAELANDA 2042552017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/1.5ML ACTUATION SOLUTION, METERED TRANSDERMAL Rx AT - TESTOSTERONERSACTAVIS LABS UT INCANDA 2045712015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/0.5GM ACTUATION GEL, METERED TRANSDERMAL Rx — - TESTOSTERONEPADAGIS ISRAELANDA 2042682015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED TRANSDERMAL Rx AB - TESTOSTERONERSACTAVIS LABS UT INCANDA 07673720153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/2.5GM PACKET GEL TRANSDERMAL Rx AB1 50MG/5GM PACKET GEL TRANSDERMAL Rx AB1 12.5MG/1.25GM ACTUATION GEL, METERED TRANSDERMAL Rx AB1 - TESTOSTERONESTRIDES PHARMA INTLANDA 07674420072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/2.5GM PACKET GEL TRANSDERMAL Rx AB1 50MG/5GM PACKET GEL TRANSDERMAL Rx AB1 - TESTOSTERONEWATSON LABSANDA 0864191983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - TESTOSTERONEDR REDDYSANDA 0864171983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - TESTOSTERONEWATSON LABSANDA 0864201983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML INJECTABLE INJECTION Discontinued — - TESTOPELRSENDO OPERATIONSANDA 080911—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG PELLET IMPLANTATION Rx —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9180194 | 3 mo ago | U-1390 | |
| 8993520 | 3 mo ago | U-1390 | |
| 8466138 | in 2 mo | U-1103 | |
| 8466137 | in 2 mo | U-1103 | |
| 8741881 | in 2 mo | U-1103 | |
| 8729057 | in 2 mo | Product | |
| 8759329 | in 2 mo | Product | |
| 8754070 | in 2 mo | Product | |
| 8466136 | in 2 mo | Product | |
| 8486925 | in 2 mo | Product | |
| 8807861 | in 6 mo | ProductU-1563 | |
| 9289586 | in 6 mo | U-1390 | |
| 8419307 | in 6 mo | U-1386 | |
| 8435944 | in 1 yr 1 mo | U-1390 | |
| 8785426 | in 7 yr 7 mo | ProductU-1531 | |
| 9662340 | in 7 yr 7 mo | ProductU-1531 | |
| 9295675 | in 7 yr 7 mo | ProductU-1531 | |
| 11744838 | in 7 yr 8 mo | U-4366 | |
| 11090312 | in 7 yr 8 mo | U-1616 |
Approval history
FDA approval span
First approval
43 yr 11 mo ago
Most recent approval
2 yr 2 mo ago
Approvals span 1983–2024 across 39 FDA applications.
Brand (NDA) 1333%
Generic (ANDA) 2667%
Testosterone: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
