morphine sulfate · Zyla · NDA 208603
Arymo Er
Earliest generic entry, as listed · earliest of 3 marketed strengths
1 Jul 2033
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 9044402, US 9549899.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9044402 | drug product, use U-1556 · sets the listed date | 1 Jul 2033 |
| US 9549899 | drug product, use U-1556 · sets the listed date | 1 Jul 2033 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208603 · 001 · RLD · discontinued | tablet, extended release, oral | 15MG | 1 Jul 2033 |
| 208603 · 002 · RLD · discontinued | tablet, extended release, oral | 30MG | 1 Jul 2033 |
| 208603 · 003 · RLD · discontinued | tablet, extended release, oral | 60MG | 1 Jul 2033 |