FDA Orange Book
Is there a generic for Sotylize?
Sotylize contains sotalol. 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 Sotylize (sotalol). The Orange Book shows its last listed patent expires August 31, 2035.
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Sotylize products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 5MG/ML (5MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 205108, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Sotylize patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10206895 | April 1, 2034 | Drug product | U-2096 | 205108 |
| 12290495 | April 1, 2034 | Method of use | U-2096 | 205108 |
| 12290495 | April 1, 2034 | Method of use | U-2494 | 205108 |
| 10206895 | April 1, 2034 | Drug product | U-2494 | 205108 |
| 11013703 | April 1, 2034 | Drug product | None | 205108 |
| 11850222 | November 19, 2034 | Method of use | U-2096 | 205108 |
| 11850222 | November 19, 2034 | Method of use | U-2494 | 205108 |
| 9724297 | August 31, 2035 | Drug product | U-2096 | 205108 |
Sotylize NDC codes
Questions
Is there a generic for Sotylize?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sotylize (sotalol). The Orange Book shows its last listed patent expires August 31, 2035.
What is the generic name for Sotylize?
The active ingredient in Sotylize is sotalol, per the FDA Orange Book.
When does the Sotylize patent expire?
The last patent listed for Sotylize in the Orange Book expires August 31, 2035. 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.