Orange Book product · Brand (NDA)
ANDROGEL
TESTOSTERONE
At a glance
Apr 29, 2011
Approved
Brand (NDA)
Application
AB
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 29, 2011
15 yr 4 mo ago
Today
Patent 8466136 expires
Listed drug product patent expiration.
Oct 12, 2026
in 4 mo
Patent 8466137 expires
Listed method-of-use patent (U-1103) expiration.
Oct 12, 2026
in 4 mo
Patent 8466138 expires
Listed method-of-use patent (U-1103) expiration.
Oct 12, 2026
in 4 mo
Patent 8486925 expires
Listed drug product patent expiration.
Oct 12, 2026
in 4 mo
Patent 8729057 expires
Listed drug product patent expiration.
Oct 12, 2026
in 4 mo
Patent 8741881 expires
Listed method-of-use patent (U-1103) expiration.
Oct 12, 2026
in 4 mo
Patent 8754070 expires
Listed drug product patent expiration.
Oct 12, 2026
in 4 mo
Patent 8759329 expires
Listed drug product patent expiration.
Oct 12, 2026
in 4 mo
Pharmaceutical detail
Active ingredient
TESTOSTERONE
Strength
1.62% (20.25MG/1.25GM ACTUATION)
Dosage form
GEL, METERED
Route
TRANSDERMAL
TE code
AB
Application
NDA 022309
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2014VOGELXOBrand (NDA)
NDA 204399 · UPSHER SMITH LABS
- 2014NATESTOBrand (NDA)
NDA 205488 · ACERUS
- 2013TESTOSTERONEBrand (NDA)
NDA 203098 · PERRIGO ISRAEL
- 2012TESTOSTERONEBrand (NDA)
NDA 202763 · ANI PHARMS
- 2011ANDRODERMBrand (NDA)
NDA 020489 · ABBVIE
- 2010FORTESTABrand (NDA)
NDA 021463 · ENDO OPERATIONS
- 2010AXIRONBrand (NDA)
NDA 022504 · ELI LILLY AND CO
- 2003ANDROGELBrand (NDA)
NDA 021015 · BESINS HLTHCARE
- 2003STRIANTBrand (NDA)
NDA 021543 · AUXILIUM PHARMS LLC
- 2002TESTIMBrand (NDA)
NDA 021454 · ENDO OPERATIONS
- 1997TESTODERM TTSBrand (NDA)
NDA 020791 · ALZA
- 1993TESTODERMBrand (NDA)
NDA 019762 · ALZA
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8466136 | Oct 12, 2026 | in 4 mo | Product |
| 8466137 | Oct 12, 2026 | in 4 mo | U-1103 |
| 8466138 | Oct 12, 2026 | in 4 mo | U-1103 |
| 8486925 | Oct 12, 2026 | in 4 mo | Product |
| 8729057 | Oct 12, 2026 | in 4 mo | Product |
| 8741881 | Oct 12, 2026 | in 4 mo | U-1103 |
| 8754070 | Oct 12, 2026 | in 4 mo | Product |
| 8759329 | Oct 12, 2026 | in 4 mo | Product |
