Generic competition · all medicines · read 12 November 2026
Is there a generic of Methylnaltrexone Bromide, and who makes it?
Methylnaltrexone Bromide appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came 16.3 years after the first brand approval. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Methylnaltrexone Bromide appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
- 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Where both are dated, the first generic approval came 16.3 years after the first brand approval.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Solution, Subcutaneous
Brand listed, no generic listed as marketed
Brand listed as marketed: Relistor. No generic is listed as marketed (3 generic products listed as discontinued).
Patents and exclusivities still listed
- 3 August 2027Patent 12303592 drug product
- 30 September 2029Patent 8420663
- 30 September 2029Patent 8822490 drug product
- 30 September 2029Patent 9180125 drug product
- 30 September 2029Patent 9492445 drug product
- 31 December 2030Patent 8247425
Tablet, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Relistor. No generic is listed as marketed.
Patents and exclusivities still listed
- 30 September 2029Patent 9180125 drug product
- 30 September 2029Patent 9492445 drug product
- 30 September 2029Patent 9724343 drug product
- 30 September 2029Patent 8420663
- 10 March 2031Patent 8956651 drug product
- 10 March 2031Patent 9314461 drug product
- 10 March 2031Patent 10376505 drug product
- 10 March 2031Patent 8524276 drug product
1 more patents are listed.
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.