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Generated: October 20, 2017

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Valganciclovir hydrochloride - Generic Drug Details

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What are the generic drug sources for valganciclovir hydrochloride and what is the scope of valganciclovir hydrochloride patent protection?

Valganciclovir hydrochloride
is the generic ingredient in two branded drugs marketed by Hoffmann La Roche, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Hetero Labs Ltd V, and Endo Pharms Inc, and is included in seven NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Valganciclovir hydrochloride has thirty-five patent family members in thirty countries and four supplementary protection certificates in four countries.

There are fifteen drug master file entries for valganciclovir hydrochloride. Ten suppliers are listed for this compound.

Summary for Generic Name: valganciclovir hydrochloride

US Patents:1
Tradenames:2
Applicants:6
NDAs:7
Drug Master File Entries: see list15
Suppliers / Packagers: see list10
Bulk Api Vendors: see list34
Clinical Trials: see list2,359
Patent Applications: see list201
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:valganciclovir hydrochloride at DailyMed

Pharmacology for Ingredient: valganciclovir hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
FOR SOLUTION;ORAL022257-001Aug 28, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe
Endo Pharms Inc
VALGANCICLOVIR HYDROCHLORIDE
valganciclovir hydrochloride
TABLET;ORAL200790-001Nov 4, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
TABLET;ORAL021304-001Mar 29, 2001ABRXYesYes► Subscribe► Subscribe► Subscribe
Actavis Labs Fl Inc
VALGANCICLOVIR HYDROCHLORIDE
valganciclovir hydrochloride
FOR SOLUTION;ORAL205220-001Jul 18, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Hetero Labs Ltd V
VALGANCICLOVIR HYDROCHLORIDE
valganciclovir hydrochloride
TABLET;ORAL205166-001Mar 18, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
VALGANCICLOVIR HYDROCHLORIDE
valganciclovir hydrochloride
TABLET;ORAL204750-001Mar 31, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
VALGANCICLOVIR HYDROCHLORIDE
valganciclovir hydrochloride
TABLET;ORAL203511-001Nov 4, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
FOR SOLUTION;ORAL022257-001Aug 28, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: valganciclovir hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
TABLET;ORAL021304-001Mar 29, 2001► Subscribe► Subscribe
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
FOR SOLUTION;ORAL022257-001Aug 28, 2009► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: valganciclovir hydrochloride

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
8,889,109Pharmaceutical dosage forms comprising valganciclovir hydrochloride► 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: valganciclovir hydrochloride

Country Document Number Estimated Expiration
Cyprus1113468► Subscribe
Chile2007003564► Subscribe
Colombia6220902► Subscribe
TaiwanI341730► Subscribe
Argentina065541► Subscribe
BrazilPI0720118► Subscribe
Israel198854► Subscribe
Portugal2101733► Subscribe
New Zealand577179► Subscribe
Taiwan200840585► 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: VALGANCICLOVIR HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/027United Kingdom► SubscribePRODUCT NAME: 2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)-METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE HYDROCHLORIDE (VALGANCICLOVIR HYDROCHLORIDE); REGISTERED: NL RVG 25992 20010920; UK PL 00031/0599 20020425
02/028Ireland► SubscribePRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013
C0003France► SubscribePRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920
00071Netherlands► SubscribePRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Novartis
Moodys
Mallinckrodt
Boehringer Ingelheim
Daiichi Sankyo
Fish and Richardson
Fuji
Cerilliant
UBS

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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