prednisone · Horizon · NDA 202020
Rayos
Earliest generic entry, as listed · earliest of 3 marketed strengths
3 Aug 2027
Other strengths are listed to 7 Jan 2028; no marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 9504699. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8168218 | product, use U-1269 | 7 Jan 2028 |
| US 9504699 | use U-1362 | 3 Aug 2027 |
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 · 202020-0011 Oct 2025
- 25 Oct 2026Generic approved · 202020-00126 Jun 2026
- 24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 202020-0023 Aug 2027
- 24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 202020-0013 Aug 2027
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202020 · 001 · RLD · discontinued | tablet, delayed release, oral | 1MG | 3 Aug 2027 |
| 202020 · 002 · RLD · discontinued | tablet, delayed release, oral | 2MG | 3 Aug 2027 |
| 202020 · 003 · RLD · discontinued | tablet, delayed release, oral | 5MG | 7 Jan 2028 |