FDA Orange Book · active-ingredient family
Baloxavir marboxil
Baloxavir marboxil: 2 brands, 1 generic; first approved Oct 24, 2018; generic available.
Generic available6 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
2
Generics (ANDA)
1
Listed patents
10
Next patent expiry
Jun 14, 2030
in 3 yr 11 mo
Brand (NDA) products
Originator applications
- GENENTECH INCNDA 21441020203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML FOR SUSPENSION ORAL Rx — 30MG/PACKET FOR SUSPENSION ORAL Rx — 40MG/PACKET FOR SUSPENSION ORAL Rx — - XOFLUZARLDGENENTECH INCNDA 21085420183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB
Generic (ANDA) products (1)
Abbreviated applications
- BALOXAVIR MARBOXILNORWICHANDA 21744920262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- M-187New use / labeling-change exclusivity (3 years)
in 1 yr 5 mo
- M-187New use / labeling-change exclusivity (3 years)
in 1 yr 5 mo
- M-187New use / labeling-change exclusivity (3 years)
in 1 yr 5 mo
- M-187New use / labeling-change exclusivity (3 years)
in 1 yr 5 mo
- M-187New use / labeling-change exclusivity (3 years)
in 1 yr 5 mo
- M-187New use / labeling-change exclusivity (3 years)
in 1 yr 5 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9815835 | in 3 yr 11 mo | Product | |
| 8927710 | in 4 yr 10 mo | Product | |
| 8987441 | in 6 yr 4 mo | SubstanceProduct | |
| 10633397 | in 9 yr 10 mo | U-2816 | |
| 10392406 | in 9 yr 10 mo | Substance | |
| 11306106 | in 11 yr 2 mo | U-2816 | |
| 10759814 | in 11 yr 2 mo | SubstanceProduct | |
| 11261198 | in 12 yr 4 mo | Product | |
| 12064438 | in 13 yr 4 mo | Product | |
| 11925648 | in 14 yr 11 mo | Product |
Approval history
FDA approval span
First approval
7 yr 11 mo ago
Most recent approval
2 mo ago
Approvals span 2018–2026 across 3 FDA applications.
Brand (NDA) 267%
Generic (ANDA) 133%
Baloxavir marboxil: 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 BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
