acyclovir · Bausch · NDA 018603, 018604, 018828, 019909, 020089, 021478
Zovirax
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 9
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018603 · 001 · RLD · discontinued | injectable, injection | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018603 · 002 · RLD · discontinued | injectable, injection | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018603 · 003 · RLD · discontinued | injectable, injection | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018604 · 001 · RLD | ointment, topical | 5% | open |
| 018828 · 001 · RLD · discontinued | capsule, oral | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019909 · 001 · RLD · discontinued | suspension, oral | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020089 · 001 · RLD · discontinued | tablet, oral | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020089 · 002 · RLD · discontinued | tablet, oral | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021478 · 001 · RLD | cream, topical | 5% | open |