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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
Formulation / Manufacturing:see details

Clinical Trials for: acyclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc
ACYCLOVIR
acyclovir
CAPSULE;ORAL075677-001Sep 28, 2005RXNo<disabled><disabled>
Teva Pharms
ACYCLOVIR
acyclovir
CAPSULE;ORAL074914-001Nov 26, 1997DISCNNo<disabled><disabled>
Stason
ACYCLOVIR
acyclovir
CAPSULE;ORAL075090-001Jan 26, 1999RXNo<disabled><disabled>
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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>
Delcor Asset Corp
ZOVIRAX
acyclovir
CAPSULE;ORAL018828-001Jan 25, 19854,199,574<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
Japan5242548<disabled in preview>
European Patent Office1837020<disabled in preview>
European Patent Office2216017<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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