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RELENZA

NDA

ZANAMIVIR | N021036 | GLAXOSMITHKLINE

1 strength0 unique patents0 unique exclusivities

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

15 trials from ClinicalTrials.gov, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza NCT01231620	Phase 3	Completed	GlaxoSmithKline	626	2011-01-15 → 2015-03-18
Pharmacokinetic Study of Oseltamivir and Intravenous Zanamivir in Healthy Adults NCT00921726	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	17	2009-07 → 2009-10
TCAD vs. Monotherapy for Influenza A in Immunocompromised Patients NCT00867139	Phase 1/2	Completed	Fred Hutchinson Cancer Center	7	2009-03 → 2010-01
Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China NCT01459081	Phase 3	Completed	Jiangsu Simcere Pharmaceutical Co., Ltd.	298	2011-10 → 2012-12
Long Term Influenza Prophylaxis With Inhaled Zanamivir or Oral Oseltamivir NCT00980109	Phase 4	Completed	University of Oxford	390	2009-09 → 2010-09
Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo Via Devices Administered Twice Daily for 5 Days NCT00989404	Phase 1	Completed	GlaxoSmithKline	18	2009-10-12 → 2009-12-07
A Study of Intravenous Zanamivir in the Treatment of Hospitalized Patients With Influenza Infection NCT01527110	Phase 3	Completed	GlaxoSmithKline	21	2012-01-01 → 2013-03-29
Zanamivir Versus Trivalent Split Virus Influenza Vaccine NCT00784784	Phase 3	Completed	Mount Sinai Hospital, Canada	64	2008-11 → 2009-06
Pharmacokinetics of Zanamivir After Single and Repeated Dose Infusion Administration in Healthy Chinese Adults NCT02377401	Phase 1	Completed	GlaxoSmithKline	24	2015-04-28 → 2015-06-19
A Study to Evaluate the Effect of Intravenous Zanamivir on Cardiac Conduction in Healthy Volunteers NCT01353729	Phase 1	Completed	GlaxoSmithKline	40	2011-05-19 → 2011-08-02

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$43.36

Highest Price

$57.53

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00173-0681-01RELENZA DISKHALER INH PWDR 5MG	$57.53	FSS	GlaxoSmithKline	07/31/2027
00173-0681-01RELENZA DISKHALER INH PWDR 5MG	$43.36	Big4	GlaxoSmithKline	07/31/2027

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

Medicare Part D Spending

CMS annual spending data for Relenza (2024)

Total Spending

$13K

Total Claims

194

Beneficiaries

114

Avg Cost/Unit

$2.89

Spending Trend

$24K(2019)→$32K(2020)→$12K(2021)→$16K(2022)→$13K(2023)→$13K(2024)

YoY Change:-9.3%

5yr CAGR:-1.2%

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

Approval Letters

21 letters from Drugs@FDA

Date	Submission	Document
Oct 25, 2023	SUPPL -34	View Letter (PDF)
Oct 21, 2021	SUPPL -32	View Letter (PDF)
Jun 27, 2018	SUPPL -30	View Letter (PDF)
Dec 22, 2011	SUPPL -27	View Letter (PDF)
Dec 15, 2010	SUPPL -25	View Letter (PDF)
May 7, 2010	SUPPL -24	View Letter (PDF)
Mar 29, 2010	SUPPL -19	View Letter (PDF)
Oct 16, 2009	SUPPL -10	View Letter (PDF)
Oct 16, 2009	SUPPL -15	View Letter (PDF)
Oct 16, 2009	SUPPL -7	View Letter (PDF)
Oct 16, 2009	SUPPL -14	View Letter (PDF)
Oct 16, 2009	SUPPL -18	View Letter (PDF)
Oct 7, 2008	SUPPL -17	View Letter (PDF)
Feb 25, 2008	SUPPL -16	View Letter (PDF)
Sep 11, 2007	SUPPL -12	View Letter (PDF)
Mar 15, 2007	SUPPL -13	View Letter (PDF)
Apr 5, 2006	SUPPL -8	View Letter (PDF)
Jun 15, 2004	SUPPL -5	View Letter (PDF)
Aug 15, 2003	SUPPL -6	View Letter (PDF)
Apr 26, 2000	SUPPL -1	View Letter (PDF)
Jul 26, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG

RLD

0 patents0 exclusivities▴

POWDER;INHALATION | Approved: Jul 26, 1999

No patent or exclusivity listings for this strength.