dexamethasone · Merck · NDA 011664, 011977, 011983, 011984, 012071, 012376
Decadron
Earliest generic entry, as listed · earliest of 9 marketed strengths
Open now
No marketed reference-listed strength; date taken from all listed strengths.
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 |
|---|---|---|---|
| 011664 · 001 · RLD · discontinued | tablet, oral | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011664 · 002 · RLD · discontinued | tablet, oral | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011664 · 003 · RLD · discontinued | tablet, oral | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011664 · 004 · RLD · discontinued | tablet, oral | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011664 · 005 · RLD · discontinued | tablet, oral | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011664 · 006 · RLD · discontinued | tablet, oral | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011977 · 001 · discontinued | ointment, ophthalmic | EQ 0.05% PHOSPHATE | open |
| 011983 · 002 · discontinued | cream, topical | EQ 0.1% PHOSPHATE | open |
| 011984 · 001 · RLD · discontinued | solution/drops, ophthalmic, otic | EQ 0.1% PHOSPHATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 012071 · 002 · RLD · discontinued | injectable, injection | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 012071 · 004 · RLD · discontinued | injectable, injection | EQ 24MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 012376 · 002 · discontinued | elixir, oral | 0.5MG/5ML | open |