About avatrombopag
Avatrombopag manufacturers are currently limited to the originator, Sobi, which sells it as Doptelet. Avatrombopag is an oral thrombopoietin receptor agonist that raises platelet counts. It is used in adults with chronic liver disease before a procedure, and in adults and children with chronic immune thrombocytopenia (ITP). No generic is approved in the US or EU. Pharmaceutical companies can prepare avatrombopag tablet and API dossiers for launch after patent expiry.
Avatrombopag key facts
|
Property |
Avatrombopag |
|---|---|
|
INN |
Avatrombopag (as maleate) |
|
Molecular formula / weight |
C29H34Cl2N6O3S2 / 649.7 g/mol (base) |
|
ATC code |
B02BX08 |
|
Drug class |
Thrombopoietin (TPO) receptor agonist |
|
Brand names |
Doptelet; Doptelet Sprinkle (oral granules) |
|
Originator |
Discovered by Astellas; developed by AkaRx / Dova Pharmaceuticals; Dova acquired by Sobi in 2019 |
|
Dosage forms and strengths |
Film-coated tablets 20 mg; oral granules (Doptelet Sprinkle, US) |
|
Indications (US) |
Thrombocytopenia in adults with chronic liver disease scheduled for a procedure; chronic ITP in adults; persistent or chronic ITP in children aged 1 year and older |
|
First approval |
US FDA, May 2018 (chronic liver disease) |
|
Other US approvals |
Adult chronic ITP, June 2019; children aged 1 and older, July 2025 (with Doptelet Sprinkle) |
|
EU approval |
2019 (chronic liver disease); 2021 (chronic ITP) |
|
Generic status |
No generic approved in the US or EU |
Avatrombopag manufacturers and licensing history
Avatrombopag was discovered by Astellas and developed by AkaRx and Dova Pharmaceuticals. The FDA approved Doptelet in May 2018 for adults with chronic liver disease scheduled for a procedure. Sobi acquired Dova in 2019.
The FDA approved avatrombopag for adult chronic ITP in June 2019. On 25 July 2025, it extended approval to children aged 1 and older with persistent or chronic ITP, together with Doptelet Sprinkle oral granules for children aged 1 to under 6. The EU approved avatrombopag in 2019 for chronic liver disease and in 2021 for chronic ITP.
No generic avatrombopag is approved in the US or EU. Generic developers are preparing API and tablet dossiers ahead of patent expiry. Buyers should confirm the API's salt and crystal form, GMP status and freedom to operate before choosing a dossier partner.
Avatrombopag dosage forms and dossier types
Avatrombopag is approved as 20 mg tablets and, in the US, as oral granules for young children. Generic developers focus on the 20 mg tablet.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Avatrombopag tablets |
20 mg |
Future US ANDA; EU CTD |
Reference Doptelet |
|
Avatrombopag oral granules |
Per US label |
US NDA (originator) |
Doptelet Sprinkle, ages 1 to under 6 |
|
Avatrombopag maleate API |
Bulk |
US DMF; EU ASMF |
Salt and crystal form are critical |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
United States |
Future ANDA |
Patent and exclusivity status |
|
European Union |
Future EU CTD |
Data protection and SPC expiry |
|
Other markets |
CTD |
Check local patents and approvals |
Avatrombopag regulatory and patent status
The FDA approved avatrombopag in May 2018, for adult ITP in June 2019, and for children with ITP on 25 July 2025. The EU approved it in 2019 and 2021. Avatrombopag is protected by patents, and the 2025 paediatric approval may add exclusivity. No generic is approved in the US or EU, so check the FDA Orange Book and national registers before development.
Avatrombopag mechanism of action and therapeutic use
Avatrombopag activates the thrombopoietin receptor on bone marrow cells, which increases platelet production. It is used to raise platelet counts before procedures in adults with chronic liver disease, and for chronic ITP in adults and children who have not responded well to other treatment. Unlike some similar drugs, it has no food restrictions related to calcium or dairy.
Avatrombopag licensing and sourcing
Avatrombopag is currently available only from Sobi. Companies interested in this molecule usually prepare future generic dossiers or API supply. Current offers and supplier contacts are listed among the avatrombopag manufacturers on Pipelinepharma.
Frequently asked questions about avatrombopag
Who manufactures avatrombopag? Sobi is the only manufacturer in the US and EU and sells avatrombopag as Doptelet.
What is avatrombopag used for? Avatrombopag raises platelet counts in adults with chronic liver disease before a procedure, and treats chronic ITP in adults and children aged 1 and older.
Is there a generic version of avatrombopag? No. No generic avatrombopag is approved in the US or EU.
What forms and strengths of avatrombopag are available? Avatrombopag is available as 20 mg tablets and, in the US, as Doptelet Sprinkle oral granules for children aged 1 to under 6.
Can children take avatrombopag? Yes. In the US, avatrombopag was approved on 25 July 2025 for children aged 1 and older with persistent or chronic ITP.
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