trofinetide · Acadia Pharms Inc · NDA 219884
Daybue Stix
Earliest generic entry, as listed · earliest of 3 marketed strengths
12 Jan 2043
Blocked by patent: US 11827600 (pediatric extension), US 12492167 (pediatric extension).
Listed patents · 4 unexpired
8 Orange Book listing rows for 4 patents, including 4 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11827600 | drug substance, drug product, use U-3556 | 12 Jan 2043 |
| US 11827600 listing row | drug substance, drug product, use U-3556 | 12 Jul 2042 |
| US 11827600 listing row | pediatric extension · sets the listed date | 12 Jan 2043 |
| US 12492167 | drug substance, drug product, use U-3556 | 12 Jan 2043 |
| US 12492167 listing row | drug substance, drug product, use U-3556 | 12 Jul 2042 |
| US 12492167 listing row | pediatric extension · sets the listed date | 12 Jan 2043 |
| US 11370755 | drug substance, drug product | 3 Feb 2041 |
| US 11370755 listing row | drug substance, drug product | 3 Aug 2040 |
| US 11370755 listing row | pediatric extension | 3 Feb 2041 |
| US 9212204 | use U-3556 | 27 Jul 2032 |
| US 9212204 listing row | use U-3556 | 27 Jan 2032 |
| US 9212204 listing row | pediatric extension | 27 Jul 2032 |
Exclusivities · 3 unexpired
| PED | pediatric (6 months added) | 10 Sep 2030 |
| ODE* | 10 Mar 2030 | |
| PED | pediatric (6 months added) | 10 Sep 2028 |
| NCE | new chemical entity (5 years) | 10 Mar 2028 |
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 |
|---|---|---|---|
| 219884 · 001 · RLD | for solution, oral | 5000MG/PACKET | 12 Jan 2043 |
| 219884 · 002 · RLD | for solution, oral | 6000MG/PACKET | 12 Jan 2043 |
| 219884 · 003 · RLD | for solution, oral | 8000MG/PACKET | 12 Jan 2043 |