varenicline tartrate · Pf Prism Cv · NDA 021928
Chantix
Earliest generic entry, as listed · earliest of 2 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 218985, Umedica · 021928-001Approved 9 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219382, Somerset Theraps Llc · 021928-001Approved 6 Jul 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218302, Micro Labs · 021928-001Approved 29 Oct 2025Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021928 · 001 · RLD | tablet, oral | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021928 · 002 · RLD | tablet, oral | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |