FDA Orange Book · active-ingredient family
Motixafortide acetate
Motixafortide acetate: 1 brand, 0 generics; first approved Sep 08, 2023; on patent until Dec 29, 2041.
On patent2 exclusivity periods
Generic status & protection
Protected until Dec 29, 2041 (earliest listed patent expiry).
Earliest patent expiry Dec 29, 2041Latest exclusivity ends Sep 08, 2030
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
2
Next patent expiry
Dec 29, 2041
in 15 yr 8 mo
Originator applications
Brand (NDA) products
AYRMID PHARMANDA 2171592023
AYRMID PHARMANDA 2171592023
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 62MG BASE/VIAL | POWDER | SUBCUTANEOUS | Rx | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Hatch-Waxman
Marketing exclusivity
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Sep 08, 2028
in 2 yr 2 mo
- ODE-442Orphan-drug exclusivity (7 years)
Sep 08, 2030
in 4 yr 3 mo
Orange Book patent file
Listed patents
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12257285 | Dec 29, 2041 | in 15 yr 8 mo | Product |
| 12268725 | Dec 29, 2041 | in 15 yr 8 mo | Product |
FDA approval span
Approval history
First approval
Sep 08, 2023
2 yr 11 mo ago
Most recent approval
Sep 08, 2023
2 yr 11 mo ago
All 1 application were approved in 2023.
Brand (NDA) 1100%
Generic (ANDA) 00%
Motixafortide acetate — 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.
