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Acyclovir - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for acyclovir?

Acyclovir is the generic ingredient in six branded drugs marketed by Watson Labs, Valeant Bermuda, Amneal Pharms, Actavis Elizabeth, Mylan Pharms Inc, Apotex Inc, Mylan, Zydus Pharms Usa Inc, Teva Pharms, Hi Tech Pharma, Teva, Dava Pharms Inc, Fougera Pharms Inc, Chartwell Molecules, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Actavis Mid Atlantic, Cadila Pharms Ltd, Lek Pharm, Taro, 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-three NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are fifty-five drug master file entries for acyclovir. Sixty-five suppliers are listed for this compound.

Summary for Generic Name: acyclovir

Tradenames:6
Patents:7
Applicants:38
NDAs:63
Drug Master File Entries: see list55
Suppliers / Packagers: see list65
Bulk Api Vendors: see list112
Clinical Trials: see list21
Patent Applications: see list6,409
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:acyclovir at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
ACYCLOVIR SODIUM
acyclovir sodium
INJECTABLE;INJECTION074930-001May 13, 1998RXNoYes► Subscribe► Subscribe
Hetero Labs Ltd V
ACYCLOVIR
acyclovir
TABLET;ORAL203834-001Oct 29, 2013RXNoNo► Subscribe► Subscribe
Cipher Pharms Us
SITAVIG
acyclovir
TABLET;BUCCAL203791-001Apr 12, 2013RXYesYes8,592,434► SubscribeY ► Subscribe
Zydus Pharms Usa Inc
ACYCLOVIR
acyclovir
TABLET;ORAL204314-002Aug 19, 2014RXNoNo► Subscribe► Subscribe
Eurohlth Intl Sarl
ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE
acyclovir sodium
INJECTABLE;INJECTION074885-001Dec 19, 1997DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: acyclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Bermuda
ZOVIRAX
acyclovir
OINTMENT;TOPICAL018604-001Mar 29, 19824,199,574► Subscribe
Mylan Pharms Inc
ZOVIRAX
acyclovir
CAPSULE;ORAL018828-001Jan 25, 19854,199,574► Subscribe
Mylan Pharms Inc
ZOVIRAX
acyclovir
TABLET;ORAL020089-002Apr 30, 19914,199,574► Subscribe
Mylan Pharms Inc
ZOVIRAX
acyclovir
TABLET;ORAL020089-001Apr 30, 19914,199,574► Subscribe
Vib
ZOVIRAX
acyclovir
CREAM;TOPICAL021478-001Dec 30, 20024,963,555► Subscribe
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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► Subscribe
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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
Spain2335712► Subscribe
Canada2647123► Subscribe
Russian Federation2008139869► Subscribe
BrazilPI0709057► Subscribe
Malaysia150072► Subscribe
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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► SubscribePRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
C0038France► SubscribePRODUCT 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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