methylnaltrexone bromide · Salix Pharms · NDA 021964, 208271
Relistor
Other strengths are listed to 10 Mar 2031.
Blocked by patent: US 8247425. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 12 unexpired
13 Orange Book listing rows for 12 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10307417 | drug product | 10 Mar 2031 |
| US 10376505 | drug product | 10 Mar 2031 |
| US 8524276 | drug product | 10 Mar 2031 |
| US 8956651 | drug product | 10 Mar 2031 |
| US 9314461 | drug product | 10 Mar 2031 |
| US 8247425 | use U-1185 · sets the listed date | 31 Dec 2030 |
| US 8420663 | use U-1185 | 30 Sep 2029 |
| US 8822490 | drug product, use U-1185 | 30 Sep 2029 |
| US 9180125 | drug product, use U-1185 | 30 Sep 2029 |
| US 9492445 | drug product, use U-1185 | 30 Sep 2029 |
| US 9724343 | drug product, use U-1185 | 30 Sep 2029 |
| US 12303592 | drug product, use U-4197, U-4198 | 3 Aug 2027 |
| US 12303592 listing row | drug product, use U-4197 | 3 Aug 2027 |
| US 12303592 listing row | drug product, use U-4198 | 3 Aug 2027 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021964 · 001 · RLD | solution, subcutaneous | 12MG/0.6ML (12MG/0.6ML) | 31 Dec 2030 |
| 021964 · 002 · RLD | solution, subcutaneous | 8MG/0.4ML (8MG/0.4ML) | 31 Dec 2030 |
| 021964 · 003 · RLD | solution, subcutaneous | 12MG/0.6ML (12MG/0.6ML) | 31 Dec 2030 |
| 208271 · 001 · RLD | tablet, oral | 150MG | 10 Mar 2031 |