FDA Orange Book
Is there a generic for Doptelet Sprinkle?
Doptelet Sprinkle contains avatrombopag. 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 Doptelet Sprinkle (avatrombopag). The Orange Book shows its last listed patent expires July 28, 2027 and its last listed exclusivity ends July 24, 2032.
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Doptelet Sprinkle products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| granule, oral | EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
NDA 219696, held by AKARX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Doptelet Sprinkle patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7638536 | July 28, 2027 | Drug substance, Drug product | None | 219696 |
Doptelet Sprinkle exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | July 24, 2028 | 219696 |
| ODE-548 | Orphan drug exclusivity | July 24, 2032 | 219696 |
Doptelet Sprinkle NDC codes
Questions
Is there a generic for Doptelet Sprinkle?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Doptelet Sprinkle (avatrombopag). The Orange Book shows its last listed patent expires July 28, 2027 and its last listed exclusivity ends July 24, 2032.
What is the generic name for Doptelet Sprinkle?
The active ingredient in Doptelet Sprinkle is avatrombopag, per the FDA Orange Book.
When does the Doptelet Sprinkle patent expire?
The last patent listed for Doptelet Sprinkle in the Orange Book expires July 28, 2027. 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.