tapentadol hydrochloride · Collegium Pharm Inc · NDA 200533
Nucynta Er
Earliest generic entry, as listed · earliest of 5 marketed strengths
22 Mar 2029
Blocked by patent: US 8536130 (pediatric extension).
Listed patents · 2 unexpired
5 Orange Book listing rows for 2 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8536130 | use U-1276 | 22 Mar 2029 |
| US 8536130 listing row | use U-1276 | 22 Sep 2028 |
| US 8536130 listing row | pediatric extension · sets the listed date | 22 Mar 2029 |
| US 11344512 | use U-3391, U-3392 | 21 Oct 2028 |
| US 11344512 listing row | use U-3391 | 21 Apr 2028 |
| US 11344512 listing row | use U-3392 | 21 Apr 2028 |
| US 11344512 listing row | pediatric extension | 21 Oct 2028 |
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 200533 · 001 · RLD | tablet, extended release, oral | EQ 50MG BASE | 22 Mar 2029 |
| 200533 · 002 · RLD | tablet, extended release, oral | EQ 100MG BASE | 22 Mar 2029 |
| 200533 · 003 · RLD | tablet, extended release, oral | EQ 150MG BASE | 22 Mar 2029 |
| 200533 · 004 · RLD | tablet, extended release, oral | EQ 200MG BASE | 22 Mar 2029 |
| 200533 · 005 · RLD | tablet, extended release, oral | EQ 250MG BASE | 22 Mar 2029 |