hydrocortisone butyrate · Bausch · NDA 018514, 018652, 018795, 019106, 019116, 019819, 022076
Locoid
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 · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018514 · 001 · RLD | cream, topical | 0.1% | open |
| 018652 · 001 · RLD · discontinued | ointment, topical | 0.1% | open |
| 018795 · 001 · discontinued | cream, topical | 0.1% | open |
| 019106 · 001 · discontinued | ointment, topical | 0.1% | open |
| 019116 · 001 · RLD | solution, topical | 0.1% | open |
| 019819 · 001 · discontinued | solution, topical | 0.1% | open |
| 022076 · 001 · RLD · discontinued | lotion, topical | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |