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Serving leading biopharmaceutical companies globally:

Healthtrust
US Department of Justice
US Army
Deloitte
Johnson and Johnson
Daiichi Sankyo
Novartis
Accenture
Harvard Business School
Colorcon

Generated: January 19, 2018

DrugPatentWatch Database Preview

Acyclovir - Generic Drug Details

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

Acyclovir
is the generic ingredient in six branded drugs marketed by Actavis Elizabeth, Apotex Inc, Boscogen, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Dava Pharms Inc, Heritage Pharms Inc, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Teva, Teva Pharms, Watson Labs, Zydus Pharms Usa Inc, Mylan Pharms Inc, VIB, Amneal Pharms, Fougera Pharms Inc, G And W Labs Inc, Glenmark Pharms Ltd, Taro, Tolmar, Valeant Bermuda, Actavis Mid Atlantic, Hi Tech Pharma, Epi Hlth, Carlsbad, Hetero Labs Ltd V, Sun Pharm Inds Ltd, Abbvie, Eurohlth Intl Sarl, Apothecon, Athenex Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hikma Pharms, Hospira, Mylan Labs Ltd, Teva Parenteral, and Glaxosmithkline, and is included in sixty-nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acyclovir has thirty-five patent family members in twenty-four countries.

There are fifty-five drug master file entries for acyclovir. Seventy suppliers are listed for this compound. There are three tentative approvals for this compound.
Tentative approvals for ACYCLOVIR
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe200MGCAPSULE;ORAL
➤ Subscribe➤ Subscribe800MGTABLET;ORAL
➤ Subscribe➤ Subscribe400MGTABLET;ORAL

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
Athenex Inc ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 074596-002 Apr 22, 1997 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc ACYCLOVIR acyclovir TABLET;ORAL 075211-001 Sep 28, 1998 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amneal Pharms ACYCLOVIR acyclovir OINTMENT;TOPICAL 204605-001 Jun 18, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Epi Hlth SITAVIG acyclovir TABLET;BUCCAL 203791-001 Apr 12, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mylan Pharms Inc ACYCLOVIR acyclovir OINTMENT;TOPICAL 202459-001 Apr 3, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Carlsbad ACYCLOVIR acyclovir TABLET;ORAL 075382-001 Apr 30, 1999 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Ranbaxy ACYCLOVIR acyclovir CAPSULE;ORAL 074975-001 Sep 30, 1998 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Cadila Pharms Ltd ACYCLOVIR acyclovir CAPSULE;ORAL 201445-001 Mar 6, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Eurohlth Intl Sarl ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE acyclovir sodium INJECTABLE;INJECTION 074885-002 Dec 19, 1997 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Parenteral ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 075627-001 Mar 28, 2001 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for acyclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Pharms Inc ZOVIRAX acyclovir TABLET;ORAL 020089-002 Apr 30, 1991 ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc ZOVIRAX acyclovir CAPSULE;ORAL 018828-001 Jan 25, 1985 ➤ Subscribe ➤ Subscribe
Vib ZOVIRAX acyclovir CREAM;TOPICAL 021478-001 Dec 30, 2002 ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc ZOVIRAX acyclovir TABLET;ORAL 020089-001 Apr 30, 1991 ➤ Subscribe ➤ Subscribe
Valeant Bermuda ZOVIRAX acyclovir OINTMENT;TOPICAL 018604-001 Mar 29, 1982 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for acyclovir

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,211,466 Mucosal bioadhesive slow release carrier for delivering active principles ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for acyclovir

Supplementary Protection Certificates for acyclovir

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB10/012 United Kingdom ➤ Subscribe PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
C0038 France ➤ Subscribe PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Fuji
Medtronic
Express Scripts
Johnson and Johnson
Teva
Dow
Boehringer Ingelheim

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 verifification 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.

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