testosterone · Besins Hlthcare · NDA 021015, 022309
Androgel
Earliest generic entry, as listed · earliest of 6 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021015 · 001 · RLD | gel, transdermal | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021015 · 002 · RLD | gel, transdermal | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021015 · 003 · RLD | gel, metered, transdermal | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 022309 · 001 · RLD | gel, metered, transdermal | 1.62% (20.25MG/1.25GM ACTUATION) | open |
| 022309 · 002 · RLD | gel, transdermal | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 022309 · 003 · RLD | gel, transdermal | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
Expired or delisted (8)
- US 8466136 · product · 12 Oct 2026
- US 8466137 · use U-1103 · 12 Oct 2026
- US 8466138 · use U-1103 · 12 Oct 2026
- US 8486925 · product · 12 Oct 2026
- US 8729057 · product · 12 Oct 2026
- US 8741881 · use U-1103 · 12 Oct 2026
- US 8754070 · product · 12 Oct 2026
- US 8759329 · product · 12 Oct 2026