FDA Orange Book
Is there a generic for Doptelet?
Doptelet 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 (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 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
NDA 210238, 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 patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7638536 | July 28, 2027 | Drug substance, Drug product | None | 210238 |
Doptelet exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-246 | Orphan drug exclusivity | June 26, 2026 | 210238 |
| I-974 | New indication | July 24, 2028 | 210238 |
| ODE-548 | Orphan drug exclusivity | July 24, 2032 | 210238 |
Doptelet NDC codes
Questions
Is there a generic for Doptelet?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Doptelet (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?
The active ingredient in Doptelet is avatrombopag, per the FDA Orange Book.
When does the Doptelet patent expire?
The last patent listed for Doptelet 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.