FDA Orange Book
Is there a generic for Exondys?
Exondys contains eteplirsen. 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 Exondys (eteplirsen). The Orange Book shows its last listed patent expires March 14, 2034.
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Exondys products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 100MG/2ML (50MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 500MG/10ML (50MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 206488, held by SAREPTA THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Exondys patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE48468 | October 27, 2028 | Method of use | U-2097 | 206488 |
| RE47769 | February 2, 2029 | Drug product | None | 206488 |
| 9506058 | March 14, 2034 | Method of use | U-1918 | 206488 |
| 9506058 | March 14, 2034 | Method of use | U-1919 | 206488 |
| 10364431 | March 14, 2034 | Method of use | U-1919 | 206488 |
| 10364431 | March 14, 2034 | Method of use | U-1918 | 206488 |
| 10337003 | March 14, 2034 | Method of use | U-1918 | 206488 |
Exondys NDC codes
Questions
Is there a generic for Exondys?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Exondys (eteplirsen). The Orange Book shows its last listed patent expires March 14, 2034.
What is the generic name for Exondys?
The active ingredient in Exondys is eteplirsen, per the FDA Orange Book.
When does the Exondys patent expire?
The last patent listed for Exondys in the Orange Book expires March 14, 2034. 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.