Acyclovir

Management of initial genital herpes. Sold as Zovirax, Avaclyr, Sitavig. Every FDA application for this active ingredient: 7 branded and 70 generic.

As of Nov 13, 2026, FDA lists 77 applications for Acyclovir (sold as Zovirax, Avaclyr, Sitavig), first approved Mar 29, 1982, with 5 new uses approved and 2 published complete response letters.

First approved: Mar 29, 1982
Applications: 77
New uses approved: 5
Complete response letters: 2
Medicare spending, 2024: $37.0M

Medicare Spending

CMS Part D and Part B, 2024, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2024	Change	Beneficiaries
Acyclovir	Part D	$36.8M	-26%	696,176
Zovirax	Part D	$170K	-5%	281
Acyclovir Sodium	Part D	$35K	-22%	87
Acyclovir Sodium	Part B	$29K	-4%	167

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Mar 29, 1982	ZoviraxNDA 18604 · New molecular entity	Bausch	17	Marketed
Jan 25, 1985	ZoviraxNDA 18828 · New dosage form	Pharmobedient	27	Discontinued
Dec 22, 1989	ZoviraxNDA 19909 · New dosage form	Pharmobedient	20	Discontinued
Apr 30, 1991	ZoviraxNDA 20089 · New dosage form	Pharmobedient	19	Discontinued
Apr 22, 1997	AcyclovirANDA 74556	Teva	11	Marketed
Apr 22, 1997	AcyclovirANDA 74578	Teva	8	Marketed
Apr 22, 1997	AcyclovirANDA 74674	Ivax Sub Teva Pharms	19	Discontinued
Apr 22, 1997	AcyclovirANDA 74727	Aurobindo Pharma USA	8	Discontinued
Apr 22, 1997	AcyclovirANDA 74828	Teva	4	Discontinued
Apr 22, 1997	AcyclovirANDA 74833	Strides Pharma Intl	1	Discontinued
Apr 22, 1997	AcyclovirANDA 74836	Ivax Sub Teva Pharms	19	Discontinued
Apr 22, 1997	AcyclovirANDA 74872	Chartwell Molecules	3	Discontinued
Apr 24, 1997	AcyclovirANDA 74834	Chartwell Molecules	3	Discontinued
Apr 28, 1997	AcyclovirANDA 74738	Actavis Mid Atlantic	10	Marketed
Jun 5, 1997	AcyclovirANDA 74870	Actavis Elizabeth	6	Discontinued
Aug 26, 1997	AcyclovirANDA 74906	Actavis Elizabeth	8	Discontinued
Oct 31, 1997	AcyclovirANDA 74889	Heritage	0	Marketed
Oct 31, 1997	AcyclovirANDA 74891	Heritage	0	Marketed
Nov 19, 1997	AcyclovirANDA 74946	Strides Pharma Intl	0	Discontinued
Nov 26, 1997	AcyclovirANDA 74914	Teva Pharms	1	Discontinued
Mar 18, 1998	AcyclovirANDA 75021	Teva Pharms	0	Discontinued
Apr 13, 1998	AcyclovirANDA 74976	Mylan	2	Discontinued
Apr 13, 1998	AcyclovirANDA 74977	Mylan	3	Discontinued
Apr 15, 1998	AcyclovirANDA 75101	Watson Labs	0	Discontinued
Sep 28, 1998	AcyclovirANDA 75211	Aurobindo Pharma USA	7	Marketed
Sep 30, 1998	AcyclovirANDA 74975	Ranbaxy	7	Discontinued
Sep 30, 1998	AcyclovirANDA 74980	Sun Pharm Inds Ltd	7	Discontinued
Jan 26, 1999	AcyclovirANDA 75090	Regcon Holdings	4	Marketed
Apr 30, 1999	AcyclovirANDA 75382	Carlsbad	4	Marketed
Dec 30, 2002	ZoviraxNDA 21478 · New dosage form	Bausch	4	Marketed
Jun 7, 2005	AcyclovirANDA 77026	Hikma	1	Discontinued
Sep 28, 2005	AcyclovirANDA 75677	Apotex	2	Marketed
Sep 29, 2005	AcyclovirANDA 77309	Apotex	1	Marketed
Apr 3, 2013	AcyclovirANDA 202459	Pharmobedient	2	Marketed
Apr 12, 2013	SitavigNDA 203791 · New dosage form	Ligand Pharms	1	Discontinued
Oct 29, 2013	AcyclovirANDA 203834	Hetero Labs Ltd V	0	Marketed
Nov 15, 2013	AcyclovirANDA 202168	Cadila Pharms Ltd	2	Marketed
Mar 6, 2014	AcyclovirANDA 201445	Cadila Pharms Ltd	0	Marketed
Jun 18, 2014	AcyclovirANDA 204605	Amneal Pharms	1	Marketed
Aug 19, 2014	AcyclovirANDA 204314	Zydus Pharms	0	Marketed
Mar 25, 2016	AcyclovirANDA 204313	Cadila	1	Marketed
May 11, 2016	AcyclovirANDA 206633	Fougera Pharms Inc	1	Marketed
Dec 21, 2016	AcyclovirANDA 205469	Sun Pharma Canada	0	Marketed
Jul 31, 2017	AcyclovirANDA 205510	Glenmark Speclt	0	Marketed
Jul 31, 2017	AcyclovirANDA 206437	Chartwell Molecular	0	Discontinued
Aug 16, 2017	AcyclovirANDA 206261	Carlsbad	0	Marketed
Nov 13, 2017	AcyclovirANDA 205591	Cosette Pharms Nc	0	Discontinued
Mar 7, 2018	AcyclovirANDA 210401	Pharmobedient	1	Marketed
Apr 6, 2018	AcyclovirANDA 209000	Alembic	1	Marketed
Jan 11, 2019	AcyclovirANDA 209971	Torrent	0	Marketed
Jan 18, 2019	AcyclovirANDA 211794	Cipla	0	Discontinued
Feb 4, 2019	AcyclovirANDA 208702	Padagis Israel	1	Marketed
Feb 20, 2019	AcyclovirANDA 205659	Padagis Israel	0	Discontinued
Mar 15, 2019	AcyclovirANDA 205974	Zydus Lifesciences	0	Marketed
Mar 29, 2019	AvaclyrNDA 202408 · New dosage form	Fera Pharms LLC	1	Discontinued
Sep 6, 2019	AcyclovirANDA 210774	Apotex	0	Discontinued
Oct 7, 2019	AcyclovirANDA 209366	Adaptis	0	Marketed
Jan 29, 2020	AcyclovirANDA 201501	Xiromed	0	Marketed
Apr 7, 2020	AcyclovirANDA 212495	Chartwell Rx	0	Marketed
Apr 23, 2020	AcyclovirANDA 212718	Chartwell Rx	1	Marketed
Jul 10, 2020	AcyclovirANDA 212252	Novitium Pharma	1	Marketed
Sep 14, 2020	AcyclovirANDA 212173	Pharmobedient	1	Marketed
Nov 9, 2020	AcyclovirANDA 208766	Amneal	1	Marketed
Jan 11, 2021	AcyclovirANDA 213951	Vistapharm LLC	1	Discontinued
May 19, 2021	AcyclovirANDA 212444	Macleods Pharms	1	Marketed
Nov 15, 2021	AcyclovirANDA 212202	Prinston	0	Discontinued
Mar 31, 2022	AcyclovirANDA 216331	Aurobindo Pharma	1	Marketed
Jul 1, 2022	AcyclovirANDA 215669	Hetero Labs Ltd Iii	1	Marketed
Aug 18, 2022	AcyclovirANDA 215724	Rubicon Research	1	Marketed
Feb 28, 2023	AcyclovirANDA 206770	Zydus Lifesciences	0	Marketed
Mar 9, 2023	AcyclovirANDA 217393	Msn	0	Marketed
Nov 21, 2023	AcyclovirANDA 212361	Alembic	0	Marketed
Jun 12, 2024	AcyclovirANDA 205470	Sun Pharma Canada	0	Marketed
May 2, 2025	AcyclovirANDA 212981	Cipla	0	Discontinued
—	AcyclovirANDA 74570	Roxane	0	Discontinued
—	AcyclovirANDA 74658	Lek Pharm	0	Discontinued
—	AcyclovirANDA 74750	Lek Pharm	0	Discontinued

Show all 77

Complete Response Letters

FDA's published letters for these applications

Letter	Product	Now
Jun 24, 2016	NDA 202408Labeling	Approved
Mar 31, 2014	NDA 202408Labeling	Approved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA