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PlainMeds

Prescription medicine

Lusutrombopag Brand names: Mulpleta

Lusutrombopag (Mulpleta) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the lusutrombopag FDA label on DailyMed (effective December 9, 2025, VANCOCIN ITALIA SRL); the NDA 210923 record on Drugs@FDA; every lusutrombopag label on DailyMed.

Highlights of the record

FDA label of December 9, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

MULPLETA is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

Forms and strengths

  • 3 mg

Film-coated tablet.

On the market

Earliest approval on file
July 31, 2018 Mulpleta, Vancocin Italia; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
No generic approved
Labelers listed (NDC)
3 of which 0 under generic applications, 3 under brand applications, repackagers included
Last listed patent
September 29, 2031 Mulpleta tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
39 through July 30, 2026

What is lusutrombopag used for?

From the label: indications and usage

MULPLETA is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. MULPLETA is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

Source: FDA drug label (Mulpleta), VANCOCIN ITALIA SRL, effective December 9, 2025 (SPL set a390aec3-6e77-45f8-95d3-d4b8c2eeee40), via openFDA; the full label on DailyMed

Is there a generic for lusutrombopag (Mulpleta)?

No generic lusutrombopag is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 3 patents for Mulpleta tablets: the compound patent runs to January 21, 2030, and the last listed entry to September 29, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 2018 earliest approval on file
  • 2031 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for lusutrombopag?

The FDA Adverse Event Reporting System holds 39 reports that list lusutrombopag among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 8 are coded as a death and 7 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

  • Death (an outcome recorded in the report)3
  • Drug Ineffective (a use or a product term, not a reaction)3
  • Nausea3
  • Ascites2
  • Diarrhoea2
  • Headache (named in the label)2
  • Hospitalisation (an outcome recorded in the report)2
  • Mesenteric Vein Thrombosis2

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Lusutrombopag side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other