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Serving leading biopharmaceutical companies globally:

UBS
Accenture
Novartis
Healthtrust
Medtronic
Deloitte
Cerilliant
McKesson
QuintilesIMS
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Generated: February 23, 2018

DrugPatentWatch Database Preview

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, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Endo Pharms Inc, and Hetero Labs Ltd V, and is included in eight NDAs. There are two patents 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.

There are fifteen drug master file entries for valganciclovir hydrochloride. Eleven suppliers are listed for this compound.
Summary for valganciclovir hydrochloride
Pharmacology for valganciclovir hydrochloride

US Patents and Regulatory Information for valganciclovir hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Fl Inc VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride FOR SOLUTION;ORAL 205220-001 Jul 18, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 204750-001 Mar 31, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Dr Reddys Labs Ltd VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 206876-001 Dec 12, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hetero Labs Ltd V VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 205166-001 Mar 18, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hoffmann La Roche VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304-001 Mar 29, 2001 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Endo Pharms Inc VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 200790-001 Nov 4, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Dr Reddys Labs Ltd VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 203511-001 Nov 4, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for valganciclovir hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304-001 Mar 29, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for valganciclovir hydrochloride

Supplementary Protection Certificates for valganciclovir hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0003 France ➤ Sign Up PRODUCT 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
C/GB02/027 United Kingdom ➤ Sign Up PRODUCT 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
02/028 Ireland ➤ Sign Up PRODUCT 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
00071 Netherlands ➤ Sign Up PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Covington
Express Scripts
Dow
Harvard Business School
Accenture
US Department of Justice
Medtronic
Deloitte

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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