macimorelin acetate · Aeterna Zentaris · NDA 205598
Macrilen
Earliest generic entry, as listed
23 Jan 2030
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by exclusivity: PED.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8192719 | — | 12 Apr 2028 |
| US 8192719 | use U-2220 | 12 Oct 2027 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 23 Jan 2030 |
| M-14 | miscellaneous (3 years) | 23 Jul 2029 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205598 · 001 · RLD · discontinued | for solution, oral | EQ 60MG BASE/POUCH | 23 Jan 2030 |