rivastigmine · Sandoz · NDA 020823, 021025, 022083

Exelon

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

  • Generic approved · ANDA 215445, Yichang Humanwell · 022083-001Approved 23 Sep 2025Detected 25 Oct 2026Historical import

Products covered · 8

NDA · productFormStrengthListed expiry
020823 · 003 · RLD · discontinuedcapsule, oralEQ 1.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**open
020823 · 004 · RLD · discontinuedcapsule, oralEQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**open
020823 · 005 · RLD · discontinuedcapsule, oralEQ 4.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**open
020823 · 006 · RLD · discontinuedcapsule, oralEQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**open
021025 · 001 · RLD · discontinuedsolution, oralEQ 2MG BASE/MLopen
022083 · 001 · RLDfilm, extended release, transdermal4.6MG/24HRopen
022083 · 002 · RLDfilm, extended release, transdermal9.5MG/24HRopen
022083 · 005 · RLDfilm, extended release, transdermal13.3MG/24HRopen