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Serving leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
Cerilliant
Boehringer Ingelheim
Argus Health
Healthtrust
Colorcon
AstraZeneca
Medtronic
Deloitte

Generated: November 19, 2017

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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-five patent family members in twenty-four countries and two supplementary protection certificates in two countries.

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

Tentative approvals for ACYCLOVIR

Applicant Application No. Strength Dosage Form
u► Subscribe200MGCAPSULE;ORAL
u► Subscribe800MGTABLET;ORAL
u► Subscribe400MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan
ACYCLOVIR
acyclovir
TABLET;ORAL074976-001Apr 13, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe
Apothecon
ACYCLOVIR SODIUM
acyclovir sodium
INJECTABLE;INJECTION074897-001Feb 27, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva Parenteral
ACYCLOVIR SODIUM
acyclovir sodium
INJECTABLE;INJECTION074969-001Aug 26, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Dava Pharms Inc
ACYCLOVIR
acyclovir
CAPSULE;ORAL074833-001Apr 22, 1997ABRXNoNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline
ZOVIRAX
acyclovir sodium
INJECTABLE;INJECTION018603-001Oct 22, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Apothecon
ACYCLOVIR SODIUM
acyclovir sodium
INJECTABLE;INJECTION074897-002Feb 27, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe
Epi Hlth
SITAVIG
acyclovir
TABLET;BUCCAL203791-001Apr 12, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan
ACYCLOVIR
acyclovir
TABLET;ORAL074976-002Apr 13, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
ACYCLOVIR
acyclovir
CAPSULE;ORAL074914-001Nov 26, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
ACYCLOVIR SODIUM
acyclovir sodium
INJECTABLE;INJECTION203927-001Mar 29, 2017APRXNoNo► 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;ORAL020089-001Apr 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
Mylan Pharms Inc
ZOVIRAX
acyclovir
TABLET;ORAL020089-002Apr 30, 1991► 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
European Patent Office1998750► Subscribe
BrazilPI0709057► Subscribe
European Patent Office2335690► Subscribe
World Intellectual Property Organization (WIPO)2007110778► Subscribe
Germany602007002996► Subscribe
Spain2335712► Subscribe
Denmark1998750► Subscribe
Israel193987► Subscribe
New Zealand571156► 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 leading biopharmaceutical companies globally:

Citi
Novartis
Deloitte
AstraZeneca
US Department of Justice
Merck
Mallinckrodt
Harvard Business School
Julphar
Dow

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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