FDA Orange Book
Is there a generic for Amondys?
Amondys contains casimersen. 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 Amondys (casimersen). The Orange Book shows its last listed patent expires November 12, 2030 and its last listed exclusivity ends February 25, 2028.
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Amondys 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 |
NDA 213026, 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.
Amondys patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE48960 | February 16, 2029 | Drug substance, Drug product | U-3087 | 213026 |
| RE48960 | February 16, 2029 | Drug substance, Drug product | U-3088 | 213026 |
| 9758783 | November 12, 2030 | Method of use | U-3088 | 213026 |
| 9758783 | November 12, 2030 | Method of use | U-3089 | 213026 |
| 10781450 | November 12, 2030 | Method of use | U-3089 | 213026 |
| 10287586 | November 12, 2030 | Drug substance, Drug product | None | 213026 |
| 9228187 | November 12, 2030 | Drug substance, Drug product | None | 213026 |
Amondys exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | February 25, 2026 | 213026 |
| ODE-347 | Orphan drug exclusivity | February 25, 2028 | 213026 |
Amondys NDC codes
Questions
Is there a generic for Amondys?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Amondys (casimersen). The Orange Book shows its last listed patent expires November 12, 2030 and its last listed exclusivity ends February 25, 2028.
What is the generic name for Amondys?
The active ingredient in Amondys is casimersen, per the FDA Orange Book.
When does the Amondys patent expire?
The last patent listed for Amondys in the Orange Book expires November 12, 2030. 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.