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XOFLUZA

NDA

BALOXAVIR MARBOXIL | N210854 | GENENTECH INC

3 strengths9 unique patents1 unique exclusivity

Patent Timeline

9 unique patents, 1 exclusivity by expiration date

Active (9)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

May. 5, 2031

Oct. 24, 2032

Jun. 14, 2030

Apr. 27, 2036

Apr. 27, 2036

Aug. 9, 2037

Sep. 25, 2038

Aug. 9, 2037

Oct. 9, 2039

M-187

Dec. 19, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Shionogi & Co., Ltd. et al v. Norwich Pharmaceuticals, Inc. et al 1:2023cv00161 baloxavir marboxil	D. Del.	2023-02-13	Terminated 2025-07-23	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

12 trials from ClinicalTrials.gov — 4 recruiting, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants NCT07827599	Phase 3	Recruiting	Hoffmann-La Roche	325	2026-10-16 → 2027-04-30
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts NCT06094010	Phase 3	Recruiting	Hoffmann-La Roche	1,100	2023-11-22 → 2027-06-30
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients NCT04712539	Phase 2	Recruiting	M.D. Anderson Cancer Center	60	2021-10-11 → 2028-02-28
Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants NCT03959332	N/A	Completed	Hoffmann-La Roche	32	2019-06-19 → 2019-07-11
Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households NCT03969212	Phase 3	Completed	Hoffmann-La Roche	4,138	2019-10-10 → 2024-05-10
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms NCT03653364	Phase 3	Completed	Hoffmann-La Roche	49	2019-01-23 → 2023-04-03
Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications NCT02949011	Phase 3	Completed	Shionogi	2,184	2017-01-11 → 2018-04-20
Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza NCT03684044	Phase 3	Completed	Hoffmann-La Roche	363	2019-01-08 → 2020-03-16
Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle NCT04141930	Phase 4	Completed	University of Washington	481	2019-11-01 → 2020-04-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$161.90

per ea

Lowest NADAC/Unit

$161.90

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50242086001XOFLUZA 40 MG TABLET	$161.90	EA	Brand	—	2026-10-21
50242087701XOFLUZA 80 MG TABLET	$161.90	EA	Brand	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$120.18

Highest Price

$166.28

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50242-0860-01XOFLUZA 40MG TAB	$120.30	Big4	Genentech USA, Inc.	09/14/2028
50242-0860-01XOFLUZA 40MG TAB	$166.28	FSS	Genentech USA, Inc.	09/14/2028
50242-0877-01XOFLUZA 80MG TAB	$120.18	Big4	Genentech USA, Inc.	09/14/2028
50242-0877-01XOFLUZA 80MG TAB	$166.28	FSS	Genentech USA, Inc.	09/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Xofluza (2024)

Total Spending

$1.2M

Total Claims

7,723

Beneficiaries

7,548

Avg Cost/Unit

$158.92

Spending Trend

$1.1M(2019)→$1.9M(2020)→$645K(2021)→$2.4M(2022)→$1.0M(2023)→$1.2M(2024)

YoY Change:-4.5%

5yr CAGR:+19.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDBALOXAVIR MARBOXIL

DMF 417942025

CHANGZHOU PHARMACEUTICAL FACTORYBALOXAVIR MARBOXIL

DMF 366572021

MSN LABORATORIES PRIVATE LTDBALOXAVIR MARBOXIL

DMF 367622022

PORTON PHARMA SOLUTIONS LTDBALOXAVIR MARBOXIL

DMF 404552024

SUZHOU RYWAY BIOTECH CO LTDBALOXAVIR MARBOXIL

DMF 424272025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Aug 11, 2026	SUPPL -24	View Letter (PDF)
Jun 2, 2025	SUPPL -23	View Letter (PDF)
Dec 20, 2024	SUPPL -21	View Letter (PDF)
Mar 4, 2024	SUPPL -20	View Letter (PDF)
Jun 16, 2023	SUPPL -18	View Letter (PDF)
Aug 12, 2022	SUPPL -9	View Letter (PDF)
Aug 12, 2022	SUPPL -5	View Letter (PDF)
Nov 25, 2020	SUPPL -4	View Letter (PDF)
Nov 25, 2020	SUPPL -10	View Letter (PDF)
Oct 17, 2019	SUPPL -1	View Letter (PDF)
Oct 25, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

9 patents1 exclusivity▴

TABLET;ORAL | Approved: Oct 24, 2018

Patents (9) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8927710	May 5, 2031	—	—	Yes	—	—
8987441	Oct 24, 2032	—	Yes	Yes	—	—
9815835	Jun 14, 2030	—	—	Yes	—	—
10392406	Apr 27, 2036	—	Yes	—	—	—
10633397	Apr 27, 2036	—	—	—		—
10759814	Aug 9, 2037	—	Yes	Yes	—	—
11261198	Sep 25, 2038	—	—	Yes	—	—
11306106	Aug 9, 2037	—	—	—		—
12064438	Oct 9, 2039	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
M-187	Dec 19, 2027	Active

#002 — 40MG

RLDAB

9 patents1 exclusivity▾

TABLET;ORAL | Approved: Oct 24, 2018

#003 — 80MG

RLDAB

9 patents1 exclusivity▾

TABLET;ORAL | Approved: Mar 18, 2021