naldemedine tosylate · Bdsi · NDA 208854
Symproic
Earliest generic entry, as listed
13 May 2033
Blocked by patent: US 10952968, US 12350377.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10952968 | substance, product | 13 May 2033 |
| US 12350377 | product | 13 May 2033 |
| US 9108975 | substance, product | 11 Nov 2031 |
| US RE46365 | substance, product | 24 Feb 2031 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208854 · 001 · RLD | tablet, oral | EQ 0.2MG BASE | 13 May 2033 |
Expired or delisted (1)
- US RE46375 · substance, product, use U-1185 · 5 Oct 2026