FDA Orange Book
Is there a generic for Relistor?
Relistor contains methylnaltrexone bromide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Relistor (methylnaltrexone bromide). The Orange Book shows its last listed patent expires March 10, 2031.
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Relistor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 12MG/0.6ML (12MG/0.6ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 12MG/0.6ML (12MG/0.6ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 8MG/0.4ML (8MG/0.4ML) | Marketed (Rx) | None | 0 | None |
| tablet, oral | 150MG | Marketed (Rx) | None | 0 | None |
NDA 021964, 208271, held by SALIX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Relistor patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12303592 | August 3, 2027 | Drug product | U-4197 | 021964 |
| 12303592 | August 3, 2027 | Drug product | U-4198 | 021964 |
| 8420663 | September 30, 2029 | Method of use | U-1185 | 021964 |
| 8822490 | September 30, 2029 | Drug product | U-1185 | 021964 |
| 9180125 | September 30, 2029 | Drug product | U-1185 | 021964 |
| 9492445 | September 30, 2029 | Drug product | U-1185 | 021964 |
| 9724343 | September 30, 2029 | Drug product | U-1185 | 208271 |
| 8247425 | December 31, 2030 | Method of use | U-1185 | 021964 |
| 8956651 | March 10, 2031 | Drug product | None | 208271 |
| 9314461 | March 10, 2031 | Drug product | None | 208271 |
| 10376505 | March 10, 2031 | Drug product | None | 208271 |
| 8524276 | March 10, 2031 | Drug product | None | 208271 |
| 10307417 | March 10, 2031 | Drug product | None | 208271 |
Relistor NDC codes
Questions
Is there a generic for Relistor?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Relistor (methylnaltrexone bromide). The Orange Book shows its last listed patent expires March 10, 2031.
What is the generic name for Relistor?
The active ingredient in Relistor is methylnaltrexone bromide, per the FDA Orange Book.
When does the Relistor patent expire?
The last patent listed for Relistor in the Orange Book expires March 10, 2031. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.