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Serving leading biopharmaceutical companies globally:

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Generated: December 14, 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, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Endo Pharms Inc, and Hetero Labs Ltd V, and is included in seven 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 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.

Pharmacology for valganciclovir hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Hoffmann La RocheVALCYTEvalganciclovir hydrochlorideFOR SOLUTION;ORAL022257-001Aug 28, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdVALGANCICLOVIR HYDROCHLORIDEvalganciclovir hydrochlorideTABLET;ORAL204750-001Mar 31, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis Labs Fl IncVALGANCICLOVIR HYDROCHLORIDEvalganciclovir hydrochlorideFOR SOLUTION;ORAL205220-001Jul 18, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Hoffmann La RocheVALCYTEvalganciclovir hydrochlorideTABLET;ORAL021304-001Mar 29, 2001ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdVALGANCICLOVIR HYDROCHLORIDEvalganciclovir hydrochlorideTABLET;ORAL203511-001Nov 4, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Hoffmann La RocheVALCYTEvalganciclovir hydrochlorideFOR SOLUTION;ORAL022257-001Aug 28, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Endo Pharms IncVALGANCICLOVIR HYDROCHLORIDEvalganciclovir hydrochlorideTABLET;ORAL200790-001Nov 4, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Hoffmann La RocheVALCYTEvalganciclovir hydrochlorideFOR SOLUTION;ORAL022257-001Aug 28, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Hetero Labs Ltd VVALGANCICLOVIR HYDROCHLORIDEvalganciclovir hydrochlorideTABLET;ORAL205166-001Mar 18, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► 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 RocheVALCYTEvalganciclovir hydrochlorideFOR SOLUTION;ORAL022257-001Aug 28, 2009► Subscribe► Subscribe
Hoffmann La RocheVALCYTEvalganciclovir hydrochlorideTABLET;ORAL021304-001Mar 29, 2001► Subscribe► Subscribe
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International Patent Family for Ingredient: valganciclovir hydrochloride

Country Document Number Estimated Expiration
Cyprus1113468► Subscribe
CroatiaP20121033► Subscribe
Israel198854► Subscribe
Slovenia2101733► Subscribe
Denmark2101733► Subscribe
Russian Federation2440118► Subscribe
Japan2010513237► Subscribe
Taiwan200840585► Subscribe
BrazilPI0720118► Subscribe
Portugal2101733► 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
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
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
00071Netherlands► SubscribePRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
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
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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
UBS
Daiichi Sankyo
Baxter
Fish and Richardson
Fuji
Cipla
Queensland Health
Chubb

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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