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Last Updated: July 2, 2022

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, 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, Bausch, Fera Pharms Llc, Alembic Pharms Ltd, Amneal Pharms, Anda Repository, Cipla, Cosette Pharms, Fougera Pharms Inc, Glenmark Pharms Sa, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Solaris Pharma Corp, Taro, Torrent, Xiromed, Actavis Mid Atlantic, Akorn, Aurobindo Pharma Ltd, Heritage Pharms Inc, Novitium Pharma, Vistapharm, Epi Hlth, Apotex Inc, Carlsbad, Hetero Labs Ltd V, Square Pharms, Sun Pharm Inds Ltd, Zydus Pharms, Abbvie, Eurohlth Intl Sarl, Am Injectables, Apothecon, Chartwell Injectable, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Teva Parenteral, and Glaxosmithkline, and is included in ninety-one NDAs. There are four 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. Sixty suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for acyclovir

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Drug Sales Revenue Trends for acyclovir

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Recent Clinical Trials for acyclovir

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

SponsorPhase
Columbia UniversityPhase 1
BayerPhase 3
University of Alabama at BirminghamPhase 1

See all acyclovir clinical trials

Generic filers with tentative approvals for ACYCLOVIR
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing200MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing800MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing400MGTABLET;ORAL

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

Medical Subject Heading (MeSH) Categories for acyclovir

US Patents and Regulatory Information for acyclovir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline ZOVIRAX acyclovir sodium INJECTABLE;INJECTION 018603-001 Oct 22, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 206606-001 Jun 13, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Strides Pharma ACYCLOVIR acyclovir CAPSULE;ORAL 074833-001 Apr 22, 1997 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 075065-001 Feb 25, 1999 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Xiromed ACYCLOVIR acyclovir OINTMENT;TOPICAL 201501-001 Jan 29, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cipla ACYCLOVIR acyclovir OINTMENT;TOPICAL 211794-001 Jan 18, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cosette Pharms ACYCLOVIR acyclovir OINTMENT;TOPICAL 205591-001 Nov 13, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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

International Patents for acyclovir

Country Patent Number Title Estimated Expiration
Turkey 201810146 See Plans and Pricing
Japan 5242548 See Plans and Pricing
Denmark 1998750 See Plans and Pricing
European Patent Office 1837020 Vehicule bioadhesif pour les muqueuses pour delivrer lentement des principes actifs (Mucosal bioadhesive slow release carrier for delivering active principles) See Plans and Pricing
Malaysia 150072 MUCOSAL BIOADHESIVE SLOW RELEASE CARRIER FOR DELIVERING ACTIVE PRINCIPLES See Plans and Pricing
Hong Kong 1121692 MUCOSAL BIOADHESIVE SLOW RELEASE CARRIER FOR DELIVERING ACTIVE PRINCIPLES See Plans and Pricing
Portugal 2509586 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for acyclovir

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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Baxter
Harvard Business School
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Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.