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XOFLUZA

NDA

BALOXAVIR MARBOXIL | N214410 | GENENTECH INC

3 strengths9 unique patents1 unique exclusivity

Patent Timeline

9 unique patents, 1 exclusivity by expiration date

Active (9)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

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

Apr. 21, 2041

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

9 trials from ClinicalTrials.gov — 1 recruiting, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
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
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
A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza NCT02954354	Phase 3	Completed	Shionogi	1,436	2016-12-08 → 2017-04-24
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms NCT03629184	Phase 3	Completed	Hoffmann-La Roche	173	2018-11-20 → 2019-04-03
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

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

API Supply Chain5 active DMFs

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

CHANGZHOU PHARMACEUTICAL FACTORYBALOXAVIR MARBOXIL

DMF 366572021

MSN LABORATORIES PRIVATE LTDBALOXAVIR MARBOXIL

DMF 367622022

PORTON PHARMA SOLUTIONS LTDBALOXAVIR MARBOXIL

DMF 404552024

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDBALOXAVIR MARBOXIL

DMF 417942025

SUZHOU RYWAY BIOTECH CO LTDBALOXAVIR MARBOXIL

DMF 424272025

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jun 2, 2025	SUPPL -8	View Letter (PDF)
Dec 20, 2024	SUPPL -7	View Letter (PDF)
Mar 4, 2024	SUPPL -6	View Letter (PDF)
Jun 16, 2023	SUPPL -5	View Letter (PDF)
Aug 12, 2022	ORIG -2	View Letter (PDF)
Sep 28, 2021	SUPPL -1	View Letter (PDF)
Dec 21, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2MG/ML

RLD

9 patents1 exclusivity▴

FOR SUSPENSION;ORAL | Approved: Nov 23, 2020

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	—	—	—		—
11925648	Apr 21, 2041	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
M-187	Dec 19, 2027	Active

#002 — 30MG/PACKET

RLD

9 patents1 exclusivity▾

FOR SUSPENSION;ORAL | Approved: May 30, 2025

#003 — 40MG/PACKET

RLD

9 patents1 exclusivity▾

FOR SUSPENSION;ORAL | Approved: May 30, 2025