FDA Orange Book
Is there a generic for Mulpleta?
Mulpleta contains lusutrombopag. 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 Mulpleta (lusutrombopag). The Orange Book shows its last listed patent expires September 29, 2031.
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Mulpleta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 3MG | Marketed (Rx) | None | 0 | None |
NDA 210923, held by VANCOCIN ITALIA SRL. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Mulpleta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8889722 | July 29, 2028 | Drug substance, Drug product | None | 210923 |
| 8530668 | January 21, 2030 | Drug substance, Drug product | None | 210923 |
| 9427402 | September 29, 2031 | Drug product | None | 210923 |
Mulpleta NDC codes
Questions
Is there a generic for Mulpleta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Mulpleta (lusutrombopag). The Orange Book shows its last listed patent expires September 29, 2031.
What is the generic name for Mulpleta?
The active ingredient in Mulpleta is lusutrombopag, per the FDA Orange Book.
When does the Mulpleta patent expire?
The last patent listed for Mulpleta in the Orange Book expires September 29, 2031. 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.