FDA Orange Book · active-ingredient family
Methylnaltrexone bromide
Methylnaltrexone bromide is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RELISTOR · NDA 208271
2
Brand (NDA)
2
Generics (ANDA)
12
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RELISTORRLD | SALIX | NDA 208271 | — | Jul 19, 2016 | |
| RELISTORRLD×3 | SALIX PHARMS | NDA 021964 | — | Sep 27, 2010 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHYLNALTREXONE BROMIDE | MYLAN LABS LTD | ANDA 208592 | — | May 28, 2025 | |
| METHYLNALTREXONE BROMIDE×2 | ACTAVIS LLC | ANDA 208112 | — | Aug 26, 2024 |
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12303592 | Aug 03, 2027 | in 1 yr 2 mo | ProductU-4197 |
| 8420663 | Sep 30, 2029 | in 3 yr 4 mo | U-1185 |
| 8822490 | Sep 30, 2029 | in 3 yr 4 mo | ProductU-1185 |
| 9180125 | Sep 30, 2029 | in 3 yr 4 mo | ProductU-1185 |
| 9492445 | Sep 30, 2029 | in 3 yr 4 mo | ProductU-1185 |
| 9724343 | Sep 30, 2029 | in 3 yr 4 mo | ProductU-1185 |
| 8247425 | Dec 31, 2030 | in 4 yr 7 mo | U-1185 |
| 8956651 | Mar 10, 2031 | in 4 yr 10 mo | Product |
| 9314461 | Mar 10, 2031 | in 4 yr 10 mo | Product |
| 10376505 | Mar 10, 2031 | in 4 yr 10 mo | Product |
| 8524276 | Mar 10, 2031 | in 4 yr 10 mo | Product |
| 10307417 | Mar 10, 2031 | in 4 yr 10 mo | Product |
Methylnaltrexone bromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
