FDA Orange Book · active-ingredient family
Testosterone undecanoate
Testosterone undecanoate: 4 brands, 0 generics; first approved Mar 05, 2014; on patent until Apr 14, 2026.
On patentHas discontinued products
Generic status & protection
Protected until Apr 14, 2026 (earliest listed patent expiry).
Earliest patent expiry
Brands (NDA)
4
Generics (ANDA)
0
Listed patents
34
Next patent expiry
Apr 14, 2026
5 mo ago
Brand (NDA) products
Originator applications
- KYZATREXRLDMARIUSNDA 21395320264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Rx — 200MG CAPSULE ORAL Rx — 50MG CAPSULE ORAL Rx — - VERITYNDA 2080882022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 112.5MG CAPSULE ORAL Rx — - JATENZORLDTOLMARNDA 20608920193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 158MG CAPSULE ORAL Rx — 198MG CAPSULE ORAL Rx — 237MG CAPSULE ORAL Rx — - ENDO OPERATIONSNDA 0222192014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG/3ML (250MG/ML) INJECTABLE INTRAMUSCULAR Rx —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11179402 | 5 mo ago | SubstanceProduct | |
| 11331325 | in 4 mo | U-2506 | |
| 7718640 | in 6 mo | Product | |
| 8338395 | in 8 mo | U-1500 | |
| 11304960 | in 2 yr 4 mo | ProductU-1500 | |
| 8865695 | in 2 yr 4 mo | U-1500 | |
| 8778922 | in 2 yr 4 mo | ProductU-1500 | |
| 8241664 | in 2 yr 7 mo | ProductU-2506 | |
| 10543219 | in 3 yr 7 mo | U-2506 | |
| 11179403 | in 3 yr 7 mo | U-2506 | |
| 11426416 | in 3 yr 7 mo | U-3420 | |
| 10617696 | in 3 yr 7 mo | SubstanceProduct | |
| 8778916 | in 3 yr 7 mo | Product | |
| 11433083 | in 4 yr 3 mo | U-1500 | |
| 11364249 | in 4 yr 3 mo | U-1500 | |
| 10716794 | in 4 yr 3 mo | U-1500 | |
| 9949985 | in 4 yr 3 mo | U-1500 | |
| 11311555 | in 4 yr 3 mo | U-1500 | |
| 10226473 | in 4 yr 3 mo | U-1500 | |
| 9943527 | in 4 yr 3 mo | U-1500 | |
| 8492369 | in 4 yr 4 mo | ProductU-2506 | |
| 10576089 | in 4 yr 4 mo | ProductU-2506 | |
| 10576090 | in 4 yr 4 mo | Product | |
| 11590146 | in 4 yr 4 mo | Product | |
| 11617758 | in 6 yr 7 mo | ProductU-2506 | |
| 12357643 | in 6 yr 7 mo | ProductU-2506 | |
| 11559530 | in 11 yr 4 mo | U-1500 | |
| 12310978 | in 12 yr 7 mo | U-4194 | |
| 11564933 | in 12 yr 9 mo | U-1103 | |
| 12605391 | in 12 yr 9 mo | U-1103 | |
| 12011503 | in 14 yr 3 mo | ProductU-3964 | |
| 12403146 | in 14 yr 9 mo | ProductU-2506 | |
| 11464735 | in 14 yr 10 mo | ProductU-1500 | |
| 12691057 | in 14 yr 10 mo | ProductU-4194 |
Approval history
FDA approval span
First approval
12 yr 9 mo ago
Most recent approval
28 d ago
Approvals span 2014–2026 across 4 FDA applications.
Brand (NDA) 4100%
Generic (ANDA) 00%
Testosterone undecanoate: 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
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- 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.
