lidocaine hydrochloride · Fresenius Kabi Usa · NDA 006488, 008048, 008816, 010418, 013077, 014127, 014394
Xylocaine
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 12
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 006488 · 002 · RLD | injectable, injection | 2% | open |
| 006488 · 007 · RLD | injectable, injection | 1% | open |
| 006488 · 008 · RLD | injectable, injection | 0.5% | open |
| 006488 · 010 · RLD | injectable, injection | 1.5% | open |
| 008048 · 001 · RLD · discontinued | ointment, topical | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 008816 · 001 · RLD · discontinued | jelly, topical | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 010418 · 005 · discontinued | injectable, injection | 1% | open |
| 010418 · 007 · discontinued | injectable, injection | 2% | open |
| 010418 · 009 · discontinued | injectable, injection | 1.5% | open |
| 013077 · 001 · discontinued | suppository, rectal | 100MG | open |
| 014127 · 001 · discontinued | solution, topical | 5% | open |
| 014394 · 001 · discontinued | aerosol, oral | 10% | open |