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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Fuji
McKesson
Novartis
Mallinckrodt
Johnson and Johnson
Cantor Fitzgerald
Daiichi Sankyo
Cerilliant
Healthtrust

Generated: September 19, 2017

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 Watson Labs, Valeant Bermuda, Amneal Pharms, Actavis Elizabeth, Mylan Pharms Inc, Apotex Inc, Glenmark Pharms Ltd, Zydus Pharms Usa Inc, Teva Pharms, Hi Tech Pharma, Mylan, Teva, Dava Pharms Inc, Fougera Pharms Inc, Chartwell Molecules, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Tolmar, Actavis Mid Atlantic, Cadila Pharms Ltd, Lek Pharm, Carlsbad Technology, Taro, Roxane, Ranbaxy, VIB, Sun Pharm Inds Ltd, Carlsbad, Heritage Pharms Inc, Boscogen, Epi Hlth, Aurobindo Pharma Ltd, Glaxosmithkline, Eurohlth Intl Sarl, Abbvie, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Teva Parenteral, Hikma Pharms, Athenex Inc, and Apothecon, and is included in sixty-eight NDAs. There are six 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-six suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: acyclovir

Tradenames:6
Patents:6
Applicants:42
NDAs:68
Drug Master File Entries: see list55
Suppliers / Packagers: see list66
Bulk Api Vendors: see list112
Clinical Trials: see list96
Patent Applications: see list7,673
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:acyclovir at DailyMed

Tentative approvals for ACYCLOVIR

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe200MGCAPSULE;ORAL
► Subscribe► Subscribe800MGTABLET;ORAL
► Subscribe► Subscribe400MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva
ACYCLOVIR
acyclovir
TABLET;ORAL074556-002Apr 22, 1997ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa Inc
ACYCLOVIR
acyclovir
CAPSULE;ORAL204313-001Mar 25, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Lek Pharm
ACYCLOVIR
acyclovir
TABLET;ORAL074658-001Apr 22, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan
ACYCLOVIR
acyclovir
CAPSULE;ORAL074727-001Apr 22, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Valeant Bermuda
XERESE
acyclovir; hydrocortisone
CREAM;TOPICAL022436-001Jul 31, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Bermuda
ZOVIRAX
acyclovir
OINTMENT;TOPICAL018604-001Mar 29, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe
Dava Pharms Inc
ACYCLOVIR
acyclovir
CAPSULE;ORAL074833-001Apr 22, 1997ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Parenteral
ACYCLOVIR SODIUM
acyclovir sodium
INJECTABLE;INJECTION074969-001Aug 26, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
ACYCLOVIR
acyclovir
TABLET;ORAL075021-002Mar 18, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe
Carlsbad
ACYCLOVIR
acyclovir
TABLET;ORAL075382-002Apr 30, 1999ABRXNoNo► Subscribe► 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, 1982► Subscribe► Subscribe
Mylan Pharms Inc
ZOVIRAX
acyclovir
TABLET;ORAL020089-002Apr 30, 1991► Subscribe► Subscribe
Mylan Pharms Inc
ZOVIRAX
acyclovir
TABLET;ORAL020089-001Apr 30, 1991► Subscribe► Subscribe
Vib
ZOVIRAX
acyclovir
CREAM;TOPICAL021478-001Dec 30, 2002► Subscribe► Subscribe
Mylan Pharms Inc
ZOVIRAX
acyclovir
CAPSULE;ORAL018828-001Jan 25, 1985► Subscribe► 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
Portugal1998750► Subscribe
Russian Federation2008139869► Subscribe
Germany602007002996► Subscribe
European Patent Office1998750► Subscribe
Japan2009531411► Subscribe
European Patent Office1837020► Subscribe
Hong Kong1121692► Subscribe
BrazilPI0709057► Subscribe
Denmark1998750► Subscribe
Japan2013513575► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Farmers Insurance
Harvard Business School
Novartis
Express Scripts
Queensland Health
McKesson
Dow
Fuji

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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