Drybench Patent.
BALOXAVIR MARBOXIL, NDA 210854
The patents and exclusivities FDA's Orange Book lists for NDA 210854 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.
FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.
- Orange Book captured
- 14 October 2026
- Paragraph IV list captured
- 17 October 2026
- Last checked
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.
Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.
Listed protection
Listed dates run from 19 Dec 2027 to 9 Oct 2039, each by its own rule; no one date stands for this product.
- Earliest listed date
- 19 Dec 2027M-187 exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 914–916
- Latest listed date
- 9 Oct 2039US 12,064,438, product patentRule R1 · Products 001, 002, 003 · patent.txt lines 12,189, 12,200, 12,211
- Latest substance patent
- 9 Aug 2037US 10,759,814, substance and product patentRule R1 · Products 001, 002, 003 · patent.txt lines 12,185, 12,196, 12,207
- Latest listed patent
- 9 Oct 2039US 12,064,438, product patentRule R1 · Products 001, 002, 003 · patent.txt lines 12,189, 12,200, 12,211
- Latest exclusivity
- 19 Dec 2027M-187 exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 914–916
12 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 210854, as listed. The sections below name products by these numbers.
Product 001 · XOFLUZA
- Dosage form; route
- TABLET;ORAL
- Strength
- 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
- Approval date as listed
- 24 Oct 2018
- Type as listed
- DISCN
- Applicant as listed
- GENENTECH INC
Product 002 · XOFLUZA
- Dosage form; route
- TABLET;ORAL
- Strength
- 40MG
- Approval date as listed
- 24 Oct 2018
- Type as listed
- RX
- Applicant as listed
- GENENTECH INC
Product 003 · XOFLUZA
- Dosage form; route
- TABLET;ORAL
- Strength
- 80MG
- Approval date as listed
- 18 Mar 2021
- Type as listed
- RX
- Applicant as listed
- GENENTECH INC
Listed patents
Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.
11 entries from 33 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 9,815,835, product patent
patent.txt lines 12,192, 12,203, 12,214- Expiry as listed
- 14 Jun 2030
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 8,927,710, product patent
patent.txt lines 12,190, 12,201, 12,212- Expiry as listed
- 5 May 2031
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 8,987,441, substance and product patent
patent.txt lines 12,191, 12,202, 12,213- Expiry as listed
- 24 Oct 2032
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003
US 10,392,406, substance patent
patent.txt lines 12,182, 12,193, 12,204- Expiry as listed
- 27 Apr 2036
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002, 003
US 10,633,397, use patent
patent.txt lines 12,183, 12,194, 12,205- Expiry as listed
- 27 Apr 2036
- Rule
- R1
- Flags
- use code U-2816
- Product numbers
- 001, 002, 003
US 10,633,397, use patent
patent.txt lines 12,184, 12,195, 12,206- Expiry as listed
- 27 Apr 2036
- Rule
- R1
- Flags
- use code U-3000
- Product numbers
- 001, 002, 003
US 10,759,814, substance and product patent
patent.txt lines 12,185, 12,196, 12,207- Expiry as listed
- 9 Aug 2037
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003
US 11,306,106, use patent
patent.txt lines 12,187, 12,198, 12,209- Expiry as listed
- 9 Aug 2037
- Rule
- R1
- Flags
- use code U-2816
- Product numbers
- 001, 002, 003
US 11,306,106, use patent
patent.txt lines 12,188, 12,199, 12,210- Expiry as listed
- 9 Aug 2037
- Rule
- R1
- Flags
- use code U-3000
- Product numbers
- 001, 002, 003
US 11,261,198, product patent
patent.txt lines 12,186, 12,197, 12,208- Expiry as listed
- 25 Sep 2038
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 12,064,438, product patent
patent.txt lines 12,189, 12,200, 12,211- Expiry as listed
- 9 Oct 2039
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
Listed exclusivities
Each exclusivity FDA lists for NDA 210854, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
M-187 exclusivity
exclusivity.txt lines 914–916- Date
- 19 Dec 2027
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
Paragraph IV list rows giving NDA 210854
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 210854, each cell as listed.
FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.
The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.
Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.
Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 210854
Baloxavir Marboxil · Tablets · 40 mg and 80 mg
RLD/NDA as listed: Xofluza 210854- First PIV submission
- 24 Oct 2022
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 15 Jul 2026
- First applicant approval
- 17 Jun 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 25 Sep 2038
Notes from the trace
- R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.
Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week