asenapine maleate · Abbvie · NDA 022117
Saphris
Earliest generic entry, as listed · earliest of 3 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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022117 · 001 · RLD | tablet, sublingual | EQ 5MG BASE | open |
| 022117 · 002 · RLD | tablet, sublingual | EQ 10MG BASE | open |
| 022117 · 003 · RLD | tablet, sublingual | EQ 2.5MG BASE | open |
Expired or delisted (10)
- US 7741358 · — · 6 Oct 2026
- US 8022228 · — · 6 Oct 2026
- US 7741358 · substance, product, use U-1961 · 6 Apr 2026
- US 7741358 · substance, product, use U-1960 · 6 Apr 2026
- US 7741358 · substance, product, use U-1893 · 6 Apr 2026
- US 7741358 · substance, product, use U-1962 · 6 Apr 2026
- US 7741358 · substance, product, use U-1963 · 6 Apr 2026
- US 7741358 · substance, product, use U-1064 · 6 Apr 2026
- US 7741358 · substance, product, use U-1966 · 6 Apr 2026
- US 8022228 · substance, product · 6 Apr 2026