FDA Orange Book
Generic for Rydapt
Rydapt contains midostaurin. 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
Yes. The generic name for Rydapt is midostaurin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Rydapt products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 25MG | Marketed (Rx) | AB | 2 | AB |
NDA 207997, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic midostaurin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN INC | 216015 | AB (A-rated, therapeutically equivalent) | May 10, 2024 | 25MG |
| DR REDDYS LABORATORIES LTD | 215921 | AB (A-rated, therapeutically equivalent) | June 28, 2024 | 25MG |
Rydapt patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7973031 | October 9, 2028 | Method of use | U-2007 | 207997 |
| 8575146 | December 2, 2030 | Method of use | U-2008 | 207997 |
Rydapt NDC codes
Questions
Is there a generic for Rydapt?
Yes. The generic name for Rydapt is midostaurin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Rydapt?
The active ingredient in Rydapt is midostaurin, per the FDA Orange Book.
When does the Rydapt patent expire?
The last patent listed for Rydapt in the Orange Book expires December 2, 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.