➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Harvard Business School
Baxter
Merck
Mallinckrodt

Last Updated: July 30, 2021

DrugPatentWatch Database Preview

ACYCLOVIR - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

What are the generic 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, Dava Pharms Inc, Heritage Pharms Inc, Ivax Sub Teva Pharms, Kenton, Lek Pharm, Mylan, Ranbaxy, Roxane, Teva, Teva Pharms, Watson Labs, Yiling, Amneal, Perrigo Uk Finco, Bausch, Fera Pharms Llc, Alembic Pharms Ltd, Amneal Pharms, Anda Repository, Cipla, Cosette, Fougera Pharms Inc, Glenmark Pharms Sa, Macleods Pharms Ltd, Mylan Pharms Inc, Solaris Pharma Corp, Taro, Torrent, Xiromed, Actavis Mid Atlantic, Akorn, Novitium Pharma, Vistapharm, Epi Hlth, Apotex Inc, Carlsbad, Hetero Labs Ltd V, Square Pharms Ltd, Sun Pharm Inds Ltd, Zydus Pharms, Abbvie, Eurohlth Intl Sarl, Apothecon, Athenex Inc, Aurobindo Pharma Ltd, Exela Pharma, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Teva Parenteral, and Glaxosmithkline, and is included in eighty-nine 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

See drug prices for ACYCLOVIR

Drug Sales Revenue Trends for ACYCLOVIR

See drug sales revenues for ACYCLOVIR

Recent Clinical Trials for ACYCLOVIR

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

SponsorPhase
University of Alabama at BirminghamPhase 1
Dr. Amr Arafa AlbadryN/A
Tanta UniversityN/A

See all ACYCLOVIR clinical trials

Generic filers with tentative approvals for ACYCLOVIR
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial200MGCAPSULE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial800MGTABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial400MGTABLET;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
Watson Labs ACYCLOVIR acyclovir CAPSULE;ORAL 075101-001 Apr 15, 1998 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Apotex Inc ACYCLOVIR acyclovir TABLET;ORAL 077309-001 Sep 29, 2005 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Pharms Inc ACYCLOVIR acyclovir OINTMENT;TOPICAL 202459-001 Apr 3, 2013 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hetero Labs Ltd V ACYCLOVIR acyclovir TABLET;ORAL 203834-002 Oct 29, 2013 AB RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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

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

Supplementary Protection Certificates for ACYCLOVIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0809498 SPC/GB10/012 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0809498 10C0038 France ⤷  Free Forever Trial 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Harvard Business School
Baxter
Merck
Mallinckrodt

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.