Prescription medicine
Avatrombopag Brand names: Doptelet
Avatrombopag (Doptelet) 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 avatrombopag FDA label on DailyMed (effective August 13, 2025, AkaRx, Inc.); the NDA 210238 record on Drugs@FDA; every avatrombopag label on DailyMed.
Highlights of the record
FDA label of August 13, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDOPTELET 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.
Forms and strengths
- 10 mg
- 20 mg
Film-coated tablet; granule.
On the market
- Earliest approval on file
- May 21, 2018 Doptelet, Akarx Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 28, 2027 Doptelet 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
- 2,571 through July 30, 2026
What is avatrombopag used for?
From the label: indications and usageDOPTELET 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. ( 1.1 ) Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. […]
Source: FDA drug label (Doptelet Sprinkle), AkaRx, Inc., effective August 13, 2025 (SPL set e2d5960d-6c18-46cc-86bd-089222b09852), via openFDA; the full label on DailyMed
Is there a generic for avatrombopag (Doptelet)?
No generic avatrombopag is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Doptelet tablets: the compound patent runs to July 28, 2027. 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
- 2027 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 avatrombopag?
The FDA Adverse Event Reporting System holds 2,571 reports that list avatrombopag among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 172 are coded as a death and 521 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Avatrombopag side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other