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Serving leading biopharmaceutical companies globally:

Medtronic
Citi
Chinese Patent Office
Julphar
Federal Trade Commission
Fuji
Farmers Insurance
AstraZeneca
Johnson and Johnson
Cipla

Generated: October 23, 2017

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Penciclovir - Generic Drug Details

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What are the generic drug sources for penciclovir and what is the scope of penciclovir freedom to operate?

Penciclovir
is the generic ingredient in one branded drug marketed by Mylan Pharms Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Penciclovir has one hundred and five patent family members in thirty-four countries and four supplementary protection certificates in two countries.

There are two drug master file entries for penciclovir. Four suppliers are listed for this compound.

Summary for Generic Name: penciclovir

US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list2
Suppliers / Packagers: see list4
Bulk Api Vendors: see list67
Clinical Trials: see list2
Patent Applications: see list4,703
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:penciclovir at DailyMed

Pharmacology for Ingredient: penciclovir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
DENAVIR
penciclovir
CREAM;TOPICAL020629-001Sep 24, 1996RXYesYes► Subscribe► Subscribe ► Subscribe
Mylan Pharms Inc
DENAVIR
penciclovir
CREAM;TOPICAL020629-001Sep 24, 1996RXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: penciclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Pharms Inc
DENAVIR
penciclovir
CREAM;TOPICAL020629-001Sep 24, 1996► Subscribe► Subscribe
Mylan Pharms Inc
DENAVIR
penciclovir
CREAM;TOPICAL020629-001Sep 24, 1996► Subscribe► Subscribe
Mylan Pharms Inc
DENAVIR
penciclovir
CREAM;TOPICAL020629-001Sep 24, 1996► Subscribe► Subscribe
Mylan Pharms Inc
DENAVIR
penciclovir
CREAM;TOPICAL020629-001Sep 24, 1996► Subscribe► Subscribe
Mylan Pharms Inc
DENAVIR
penciclovir
CREAM;TOPICAL020629-001Sep 24, 1996► Subscribe► Subscribe
Mylan Pharms Inc
DENAVIR
penciclovir
CREAM;TOPICAL020629-001Sep 24, 1996► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: penciclovir

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
5,075,445 Guanine derivatives► Subscribe
6,388,074 Process for the preparation of purine derivatives► Subscribe
5,886,215 2-acetoxymethyl-4-halo-butyl-1-yl acetates► Subscribe
5,250,688 Purine derivatives► Subscribe
6,187,922 Process for the preparation of purine derivatives► Subscribe
6,573,378 Antiviral guanine derivatives► Subscribe
5,246,937 Purine derivatives► Subscribe
5,684,153 Process for the preparation of purine derivatives► 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: penciclovir

Country Document Number Estimated Expiration
Hong Kong218996► Subscribe
Hong Kong128693► Subscribe
HungaryT62472► Subscribe
Singapore114493► Subscribe
United Kingdom8325271► Subscribe
Austria142880► Subscribe
World Intellectual Property Organization (WIPO)8705604► Subscribe
Spain535283► Subscribe
Spain8603887► Subscribe
HungaryT47576► 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: PENCICLOVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB94/002United Kingdom► SubscribeSPC/GB94/002: 20050910, EXPIRES: 20081209
C0015Belgium► SubscribePRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228
C0033Belgium► SubscribePRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: 981 IS 110 F 7; 19970206; FIRST REGISTRATION: GB 10592/0078 19960228
C/GB96/014United Kingdom► SubscribeSPC/GB96/014: 20040810, EXPIRES: 20090809
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Covington
Baxter
Dow
Farmers Insurance
Argus Health
Teva
Merck
Cantor Fitzgerald
Federal Trade Commission

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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