FDA Orange Book
Is there a generic for Valchlor?
Valchlor contains mechlorethamine. 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 Valchlor (mechlorethamine). The Orange Book shows its last listed patent expires July 8, 2029.
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Valchlor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | EQ 0.016% BASE | Marketed (Rx) | None | 0 | None |
NDA 202317, held by HELSINN BIREX PHARMACEUTICALS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Valchlor patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8501819 | March 7, 2026 | Method of use | U-1427 | 202317 |
| 8450375 | March 7, 2026 | Drug product | None | 202317 |
| 8501818 | March 7, 2026 | Drug product | None | 202317 |
| 7838564 | March 7, 2026 | Drug product | None | 202317 |
| 9382191 | March 7, 2026 | Drug product | None | 202317 |
| 7872050 | July 8, 2029 | Method of use | U-1427 | 202317 |
Valchlor NDC codes
Questions
Is there a generic for Valchlor?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Valchlor (mechlorethamine). The Orange Book shows its last listed patent expires July 8, 2029.
What is the generic name for Valchlor?
The active ingredient in Valchlor is mechlorethamine, per the FDA Orange Book.
When does the Valchlor patent expire?
The last patent listed for Valchlor in the Orange Book expires July 8, 2029. 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.