FDA Orange Book
Is there a generic for Alkindi Sprinkle?
Alkindi Sprinkle contains hydrocortisone. 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 Alkindi Sprinkle (hydrocortisone). The Orange Book shows its last listed patent expires May 12, 2034.
Run it in Rivvi
Map Alkindi Sprinkle and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Alkindi Sprinkle products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| granule, oral | 0.5MG | Marketed (Rx) | None | 0 | None |
| granule, oral | 1MG | Marketed (Rx) | None | 0 | None |
| granule, oral | 2MG | Marketed (Rx) | None | 0 | None |
| granule, oral | 5MG | Marketed (Rx) | None | 0 | None |
NDA 213876, held by ETON PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Alkindi Sprinkle patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9717740 | November 19, 2032 | Method of use | U-3075 | 213876 |
| 9675559 | January 10, 2033 | Method of use | U-3075 | 213876 |
| 9649280 | May 12, 2034 | Drug product | U-3075 | 213876 |
Alkindi Sprinkle NDC codes
Questions
Is there a generic for Alkindi Sprinkle?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Alkindi Sprinkle (hydrocortisone). The Orange Book shows its last listed patent expires May 12, 2034.
What is the generic name for Alkindi Sprinkle?
The active ingredient in Alkindi Sprinkle is hydrocortisone, per the FDA Orange Book.
When does the Alkindi Sprinkle patent expire?
The last patent listed for Alkindi Sprinkle in the Orange Book expires May 12, 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.