FDA Orange Book
Is there a generic for Welireg?
Welireg contains belzutifan. 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 Welireg (belzutifan). The Orange Book shows its last listed patent expires June 30, 2042 and its last listed exclusivity ends June 12, 2029.
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Welireg products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 40MG | Marketed (Rx) | None | 0 | None |
NDA 215383, held by MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Welireg patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE49948 | September 5, 2034 | Drug substance, Drug product | U-4195 | 215383 |
| 9908845 | September 5, 2034 | Drug substance, Drug product | U-4195 | 215383 |
| 9908845 | September 5, 2034 | Drug substance, Drug product | U-3201 | 215383 |
| RE49948 | September 5, 2034 | Drug substance, Drug product | U-4176 | 215383 |
| 9908845 | September 5, 2034 | Drug substance, Drug product | U-4176 | 215383 |
| RE49948 | September 5, 2034 | Drug substance, Drug product | U-3201 | 215383 |
| RE49948 | September 5, 2034 | Drug substance, Drug product | U-4565 | 215383 |
| 9908845 | September 5, 2034 | Drug substance, Drug product | U-4565 | 215383 |
| 10335388 | April 14, 2036 | Method of use | U-4565 | 215383 |
| 12358870 | June 30, 2042 | Drug product | None | 215383 |
Welireg exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 13, 2026 | 215383 |
| I-931 | New indication | December 14, 2026 | 215383 |
| I-968 | New indication | May 14, 2028 | 215383 |
| ODE-364 | Orphan drug exclusivity | August 13, 2028 | 215383 |
| I-994 | New indication | June 12, 2029 | 215383 |
Welireg NDC codes
Questions
Is there a generic for Welireg?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Welireg (belzutifan). The Orange Book shows its last listed patent expires June 30, 2042 and its last listed exclusivity ends June 12, 2029.
What is the generic name for Welireg?
The active ingredient in Welireg is belzutifan, per the FDA Orange Book.
When does the Welireg patent expire?
The last patent listed for Welireg in the Orange Book expires June 30, 2042. 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.