Viewing data from:

ZOVIRAX

NDA

ACYCLOVIR SODIUM | N018603 | GLAXOSMITHKLINE

3 strengths0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

4 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Pitney, Hardin, Kipp & Szuch FDA-1996-P-0034 · 7 docket documents The law firm Pitney, Hardin, Kipp & Szuch filed this citizen petition pursuant to 21 CFR 314.93 requesting that the FDA permit the filing of an Abbreviated New Drug Application for Acyclovir Cream, 5%, which differs from the listed drug Zovirax Ointment, 5% only in dosage form, with the petitioner a	Other	2017-12-26	Granted	Pitney, Hardin, Kipp & Szuch
Citizen Petition from Yiling Pharmaceutical, Ltd FDA-2017-P-2043 · 6 docket documents Yiling Pharmaceutical Ltd filed this citizen petition under 21 CFR 10.25(a) and 10.30 requesting that the FDA select a different listed drug as the reference standard for ZOVIRAX (Acyclovir) Capsules 200mg for ANDA submissions, citing that the current reference standard from Mylan Pharmaceuticals In	505(q)	2017-04-03	Granted	Yiling Pharmaceutical, Ltd
Lachman Consultant Services, Inc. - Citizen Petition FDA-2013-P-1515 · 4 docket documents Lachman Consultant Services, Inc. filed this citizen petition on November 15, 2013, requesting that the FDA Commissioner determine whether ZOVIRAX (acyclovir sodium) for Injection, 1 g base per vial, NDA 18,603, held by GlaxoSmithKline, was voluntarily withdrawn from sale for safety or efficacy reas	505(q)	2013-12-11	Denied	—
Paddock Laboratories, Inc., (Winston & Strawn LLP) - Citizen Petition FDA-2011-P-0486 · 4 docket documents Paddock Laboratories, Inc. filed a citizen petition on June 10, 2011, seeking paragraph IV patent certifications for numerous generic drug products including abacavir sulfate, various combination antiretroviral therapies, acyclovir sodium, albuterol sulfate formulations, alendronate sodium, and many	Other	2011-07-19	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

71 trials from ClinicalTrials.gov — 1 recruiting, 60 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration NCT03178149	Phase 1	Recruiting	Astellas Institute for Regenerative Medicine	42	2018-07-13 → 2026-06-30
A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation NCT00723229	Phase 4	Completed	University of Washington	48	2008-08 → 2011-09
Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis NCT00361881	Phase 3	Completed	Medivir	1,443	2006-07 → 2007-12
Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia NCT00061945	Phase 1/2	Completed	National Cancer Institute (NCI)	302	2003-06 → 2012-10
Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores NCT02483182	Phase 2	Completed	Shulov Innovate for Science Ltd. 2012	210	2015-09 → 2018-06-24
Bioequivalence of Two Formulations of Acyclovir NCT02255734	Phase 4	Completed	Yung Shin Pharm. Ind. Co., Ltd.	14	2014-04
A Multicenter, Double Blind, Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4+ Counts Less Than 200 Cells/mm3 NCT00000712	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	400	— → 1994-11
Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection NCT00004644	Phase 1/2	Completed	National Center for Research Resources (NCRR)	25	1995-02
Phase 2 Trial of Carfilzomib for Metastatic Castration-resistant Prostate Cancer Following Treatment NCT02047253	Phase 2	Completed	University of Alabama at Birmingham	28	2014-04 → 2017-07-14
Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth NCT00004757	Phase 3	Completed	National Center for Research Resources (NCRR)	—	1992-08

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

Medicare Part D Spending

CMS annual spending data for Zovirax (2024)

Total Spending

$170K

Total Claims

600

Beneficiaries

281

Avg Cost/Unit

$28.57

Spending Trend

$4.8M(2019)→$1.8M(2020)→$584K(2021)→$237K(2022)→$179K(2023)→$170K(2024)

YoY Change:-7.5%

5yr CAGR:-32.5%

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

Medicare Part B Spending

CMS physician-administered drug spending for Acyclovir Sodium (2024)

Total Spending

$29K

Total Claims

477

Beneficiaries

167

ASP Price

$0.04

Spending Trend

$29K(2019)→$47K(2020)→$30K(2021)→$29K(2022)→$30K(2023)→$29K(2024)

YoY Change:-2.3%

5yr CAGR:-7.7%

HCPCS: J0133 — Injection, acyclovir, 5 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain3 active DMFs

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

EXCELLA GMBH AND CO KGACYCLOVIR SODIUM

DMF 109451994

SOLARA ACTIVE PHARMA SCIENCES LTDACYCLOVIR SODIUM

DMF 242892010

RAJASTHAN ANTIBIOTICS LTDACYCLOVIR SODIUM (STERILE)

DMF 408662024

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Feb 13, 2019	SUPPL -30	View Letter (PDF)
May 27, 2004	SUPPL -27	View Letter (PDF)
Jan 29, 2002	SUPPL -23	View Letter (PDF)
Jan 29, 2002	SUPPL -25	View Letter (PDF)
Jan 29, 2002	SUPPL -24	View Letter (PDF)
Jun 2, 1998	SUPPL -19	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 22, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 29, 1989

#003 — EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Aug 30, 1983