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Last Updated: April 14, 2021

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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, 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, Mylan Pharms Inc, Solaris Pharma Corp, Taro, Torrent, Xiromed, Actavis Mid Atlantic, Akorn, Novitium Pharma, 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-seven 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
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
  Start Trial  Start Trial200MGCAPSULE;ORAL
  Start Trial  Start Trial800MGTABLET;ORAL
  Start Trial  Start 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
Bausch XERESE acyclovir; hydrocortisone CREAM;TOPICAL 022436-001 Jul 31, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Square Pharms Ltd ACYCLOVIR acyclovir TABLET;ORAL 209366-001 Oct 7, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan ACYCLOVIR acyclovir TABLET;ORAL 075211-002 Sep 28, 1998 DISCN No No   Start Trial   Start Trial   Start 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
Bausch ZOVIRAX acyclovir OINTMENT;TOPICAL 018604-001 Mar 29, 1982   Start Trial   Start Trial
Mylan ZOVIRAX acyclovir CAPSULE;ORAL 018828-001 Jan 25, 1985   Start Trial   Start Trial
Mylan ZOVIRAX acyclovir TABLET;ORAL 020089-002 Apr 30, 1991   Start Trial   Start 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   Start Trial PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0809498 10C0038 France   Start 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

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Serving leading biopharmaceutical companies globally:

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Baxter
Harvard Business School
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Dow

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