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Acyclovir - Generic Drug Details

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Acyclovir is the generic ingredient in six branded drugs marketed by Watson Labs, Valeant Bermuda, Amneal Pharms, Actavis Elizabeth, Delcor Asset, Apotex Inc, Mylan, Zydus Pharms Usa Inc, Teva Pharms, Hi Tech Pharma, Teva, Delcor Asset Corp, Dava Pharms Inc, Fougera Pharms Inc, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Actavis Mid Atlantic, Cadila Pharms Ltd, Lek Pharm, Mylan Pharms Inc, Roxane, Ranbaxy, VIB, Sun Pharm Inds Ltd, Carlsbad, Heritage Pharms Inc, Stason, Cipher Pharms Us, Aurobindo Pharma Ltd, Glaxosmithkline, Eurohlth Intl Sarl, Abbvie, Fresenius Kabi Usa, Hospira, Teva Parenteral, Hikma Pharms Llc, Amphastar Pharms Inc, and Apothecon, and is included in sixty-two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-two patent family members in twenty-four countries.

There are fifty-four drug master file entries for acyclovir. Fifty-eight suppliers are listed for this compound.

Summary for Generic Name: acyclovir

Tradenames:6
Patents:6
Applicants:38
NDAs:62
Drug Master File Entries: see list54
Suppliers / Packaging: see list58
Therapeutic Class:Antivirals
Drug Prices:see low prices

Clinical Trials for: acyclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipher Pharms Us
SITAVIG
acyclovir
TABLET;BUCCAL203791-001Apr 12, 2013RXYesApr 12, 2016
Hospira
ACYCLOVIR SODIUM
acyclovir sodium
INJECTABLE;INJECTION075065-001Feb 25, 1999DISCNNo
Dava Pharms Inc
ACYCLOVIR
acyclovir
TABLET;ORAL074834-001Apr 24, 1997DISCNNo
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Expired Orange Book Patents for Generic Ingredient: acyclovir

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vib
ZOVIRAX
acyclovir
CREAM;TOPICAL021478-001Dec 30, 20024,963,555<disabled>
Valeant Bermuda
ZOVIRAX
acyclovir
OINTMENT;TOPICAL018604-001Mar 29, 19824,199,574<disabled>
Delcor Asset Corp
ZOVIRAX
acyclovir
TABLET;ORAL020089-002Apr 30, 19914,199,574<disabled>
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Non-Orange Book Patents for Generic Ingredient: 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
8,211,466Mucosal bioadhesive slow release carrier for delivering active principles<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: acyclovir

Country Document Number Estimated Expiration
Serbia51342<disabled in preview>
European Patent Office1998750<disabled in preview>
European Patent Office2509586<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ACYCLOVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB10/012United Kingdom<disabled>PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
C0038France<disabled>PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
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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 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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