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Last Updated: July 16, 2024

ACYCLOVIR - Generic Drug Details


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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, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Heritage Pharms, Indoco, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Strides Pharma, Teva, Teva Pharms, Watson Labs, Yiling, Alembic, Amneal, Padagis Israel, Zydus Lifesciences, Bausch, Fera Pharms Llc, 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, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, MSN, Novitium Pharma, Rubicon, Vistapharm Llc, Lnhc, 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, Hainan Poly, Hospira, Mylan Labs Ltd, Teva Parenteral, and Glaxosmithkline, and is included in ninety-seven 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. Sixty-nine 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
Rehab WeridaN/A
University Hospital, ToulousePhase 1
Ho Chi Minh City Hospital of Dermato-VenereologyN/A

See all ACYCLOVIR clinical trials

Generic filers with tentative approvals for ACYCLOVIR
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up200MGCAPSULE;ORAL
⤷  Sign Up⤷  Sign Up800MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up400MGTABLET;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
Mylan Labs Ltd ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 203927-002 Mar 29, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novitium Pharma ACYCLOVIR acyclovir SUSPENSION;ORAL 212252-001 Jul 10, 2020 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex ACYCLOVIR acyclovir CAPSULE;ORAL 075677-001 Sep 28, 2005 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cipla ACYCLOVIR acyclovir OINTMENT;TOPICAL 211794-001 Jan 18, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 206535-001 Aug 31, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ivax Sub Teva Pharms ACYCLOVIR acyclovir TABLET;ORAL 074836-001 Apr 22, 1997 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 020089-002 Apr 30, 1991 ⤷  Sign Up ⤷  Sign Up
Mylan ZOVIRAX acyclovir CAPSULE;ORAL 018828-001 Jan 25, 1985 ⤷  Sign Up ⤷  Sign Up
Bausch ZOVIRAX acyclovir OINTMENT;TOPICAL 018604-001 Mar 29, 1982 ⤷  Sign Up ⤷  Sign Up
Mylan ZOVIRAX acyclovir TABLET;ORAL 020089-001 Apr 30, 1991 ⤷  Sign Up ⤷  Sign Up
Bausch ZOVIRAX acyclovir CREAM;TOPICAL 021478-001 Dec 30, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ACYCLOVIR

Country Patent Number Title Estimated Expiration
Russian Federation 2420267 БИОАДГЕЗИВНЫЙ НОСИТЕЛЬ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ ДЛЯ СЛИЗИСТЫХ ОБОЛОЧЕК, ПРЕДНАЗНАЧЕННЫЙ ДЛЯ ДОСТАВКИ АКТИВНЫХ КОМПОНЕНТОВ (BIOADHESIVE CARRIER WITH DELAYED RELEASE FOR MUCOUS MEMBRANES, INTENDED FOR DELIVERY OF ACTIVE COMPONENTS) ⤷  Sign Up
European Patent Office 1998750 VEHICULE BIOADHESIF POUR LES MUQUEUSES POUR DELIVRER LENTEMENT DES PRINCIPES ACTIFS (MUCOSAL BIOADHESIVE SLOW RELEASE CARRIER FOR DELIVERING ACTIVE PRINCIPLES) ⤷  Sign Up
European Patent Office 1837020 Vehicule bioadhesif pour les muqueuses pour delivrer lentement des principes actifs (Mucosal bioadhesive slow release carrier for delivering active principles) ⤷  Sign Up
Portugal 1998750 ⤷  Sign Up
Japan 2013513575 ⤷  Sign Up
Austria E446743 ⤷  Sign Up
>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 ⤷  Sign Up PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0809498 10C0038 France ⤷  Sign Up 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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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.