paroxetine hydrochloride · Apotex · NDA 020031, 020710, 020885
Paxil
Earliest generic entry, as listed · earliest of 4 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
- 25 Oct 2026Generic approved · 020710-0015 Mar 2026
Products covered · 10
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020031 · 001 · RLD | tablet, oral | EQ 10MG BASE | open |
| 020031 · 002 · RLD | tablet, oral | EQ 20MG BASE | open |
| 020031 · 003 · RLD | tablet, oral | EQ 30MG BASE | open |
| 020031 · 004 · discontinued | tablet, oral | EQ 50MG BASE | open |
| 020031 · 005 · RLD | tablet, oral | EQ 40MG BASE | open |
| 020710 · 001 · RLD · discontinued | suspension, oral | EQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020885 · 001 · RLD · discontinued | capsule, oral | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020885 · 002 · RLD · discontinued | capsule, oral | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020885 · 003 · RLD · discontinued | capsule, oral | EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020885 · 004 · RLD · discontinued | capsule, oral | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |