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Last Updated: September 30, 2023

Acyclovir - Generic Drug Details

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What are the generic drug sources for acyclovir and what is the scope of freedom to operate?

Acyclovir is the generic ingredient in seven branded drugs marketed by Actavis Elizabeth, Apotex, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Heritage Pharms, Ivax Sub Teva Pharms, Kenton, Lek Pharm, Mylan, Ranbaxy, Roxane, Strides Pharma, Teva, Teva Pharms, Watson Labs, Yiling, Amneal, Padagis Israel, Zydus Lifesciences, Bausch, Fera Pharms Llc, Alembic, Amneal Pharms, Anda Repository, Chartwell Rx, Cipla, Cosette, Fougera Pharms Inc, Glenmark Pharms Sa, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Taro, Torrent, Xiromed, Actavis Mid Atlantic, Akorn, Aurobindo Pharma, Heritage Pharms Inc, Hetero Labs Ltd Iii, MSN, Novitium Pharma, Rubicon, Vistapharm, Epi Hlth, Apotex Inc, Carlsbad, Hetero Labs Ltd V, Square Pharms, Sun Pharm Inds Ltd, Zydus Pharms, Abbvie, Eurohlth Intl Sarl, Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Teva Parenteral, and Glaxosmithkline, and is included in ninety-five NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acyclovir has forty-six patent family members in twenty-nine countries.

There are fifty-six drug master file entries for acyclovir. Seventy-one suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for acyclovir

International Patents:	46
US Patents:	3
Tradenames:	7
Applicants:	66
NDAs:	95
Drug Master File Entries:	56
Finished Product Suppliers / Packagers:	71
Raw Ingredient (Bulk) Api Vendors:	184
Clinical Trials:	127
Patent Applications:	3,826
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for acyclovir
Drug Sales Revenues:	Drug sales revenues for acyclovir
What excipients (inactive ingredients) are in acyclovir?	acyclovir excipients list
DailyMed Link:	acyclovir at DailyMed

See drug prices for acyclovir

See drug sales revenues for acyclovir

Recent Clinical Trials for acyclovir

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rehab Werida	N/A
University Hospital, Toulouse	Phase 1
Ho Chi Minh City Hospital of Dermato-Venereology	N/A

See all acyclovir clinical trials

Generic filers with tentative approvals for ACYCLOVIR

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	200MG	CAPSULE;ORAL
⤷ Try a Trial	⤷ Try a Trial	800MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	400MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for acyclovir

Drug Class	Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	DNA Polymerase Inhibitors

Medical Subject Heading (MeSH) Categories for acyclovir

Antiviral Agents

US Patents and Regulatory Information for acyclovir

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fera Pharms Llc	AVACLYR	acyclovir	OINTMENT;OPHTHALMIC	202408-001	Mar 29, 2019		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	ACYCLOVIR	acyclovir	TABLET;ORAL	074976-001	Apr 13, 1998		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	075065-001	Feb 25, 1999		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lek Pharm	ACYCLOVIR	acyclovir	CAPSULE;ORAL	074750-001	Apr 22, 1997		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Pharms	ACYCLOVIR	acyclovir	TABLET;ORAL	075021-002	Mar 18, 1998		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for acyclovir

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	ZOVIRAX	acyclovir	CAPSULE;ORAL	018828-001	Jan 25, 1985	⤷ Try a Trial	⤷ Try a Trial
Mylan	ZOVIRAX	acyclovir	TABLET;ORAL	020089-001	Apr 30, 1991	⤷ Try a Trial	⤷ Try a Trial
Bausch	ZOVIRAX	acyclovir	OINTMENT;TOPICAL	018604-001	Mar 29, 1982	⤷ Try a Trial	⤷ Try a Trial
Mylan	ZOVIRAX	acyclovir	TABLET;ORAL	020089-002	Apr 30, 1991	⤷ Try a Trial	⤷ Try a Trial
Bausch	ZOVIRAX	acyclovir	CREAM;TOPICAL	021478-001	Dec 30, 2002	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for acyclovir

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Country	Patent Number	Title	Estimated Expiration
Japan	2013513575		⤷ Try a Trial
Serbia	51342		⤷ Try a Trial
Montenegro	01180		⤷ Try a Trial
Turkey	201810146		⤷ Try a Trial
Spain	2678122		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for acyclovir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0809498	10C0038	France	⤷ Try a Trial	PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
0809498	SPC/GB10/012	United Kingdom	⤷ Try a Trial	PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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