FDA Orange Book · active-ingredient family
Avatrombopag maleate
Avatrombopag maleate: 2 brands, 0 generics; first approved May 21, 2018; on patent until Jul 28, 2027.
On patent5 exclusivity periods
Generic status & protection
Protected until Jul 28, 2027 (earliest listed patent expiry).
Earliest patent expiry Jul 28, 2027Latest exclusivity ends Jul 24, 2032
Brands (NDA)
2
Generics (ANDA)
0
Listed patents
1
Next patent expiry
Jul 28, 2027
in 1 yr 1 mo
Originator applications
Brand (NDA) products
AKARX INCNDA 2196962025
AKARX INCNDA 2196962025
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 10MG BASE | GRANULE | ORAL | Rx | — |
AKARX INCNDA 2102382018
AKARX INCNDA 2102382018
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 20MG BASE | TABLET | ORAL | Rx | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Hatch-Waxman
Marketing exclusivity
Marketing exclusivity (5)
- NPNew product exclusivity (3 years)
Jul 24, 2028
in 2 yr 1 mo
- ODE-548Orphan-drug exclusivity (7 years)
Jul 24, 2032
in 6 yr 1 mo
- I-974New indication exclusivity (3 years)
Jul 24, 2028
in 2 yr 1 mo
- ODE-246Orphan-drug exclusivity (7 years)
Jun 26, 2026
17 d ago
- ODE-548Orphan-drug exclusivity (7 years)
Jul 24, 2032
in 6 yr 1 mo
Orange Book patent file
Listed patents
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7638536 | Jul 28, 2027 | in 1 yr 1 mo | SubstanceProduct |
FDA approval span
Approval history
First approval
May 21, 2018
8 yr 3 mo ago
Most recent approval
Jul 24, 2025
1 yr ago
Approvals span 2018–2025 across 2 FDA applications.
Brand (NDA) 2100%
Generic (ANDA) 00%
Avatrombopag maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
