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Last Updated: April 14, 2021

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VALCYTE Drug Profile

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When do Valcyte patents expire, and when can generic versions of Valcyte launch?

Valcyte is a drug marketed by Hoffmann La Roche and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-six patent family members in thirty-one countries.

The generic ingredient in VALCYTE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

Drug patent expirations by year for VALCYTE
Drug Prices for VALCYTE

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Recent Clinical Trials for VALCYTE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Karolinska University HospitalPhase 2
Cecilia Soderberg-NauclerPhase 2
Karolinska InstitutetPhase 2

See all VALCYTE clinical trials

Paragraph IV (Patent) Challenges for VALCYTE
Tradename Dosage Ingredient NDA Submissiondate
VALCYTE FOR SOLUTION;ORAL valganciclovir hydrochloride 022257 2011-03-21
VALCYTE TABLET;ORAL valganciclovir hydrochloride 021304 2005-12-27

US Patents and Regulatory Information for VALCYTE

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;ORAL 022257-001 Aug 28, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hoffmann La Roche VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304-001 Mar 29, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for VALCYTE

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

Supplementary Protection Certificates for VALCYTE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0694547 03C0003 France   Start Trial 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
0694547 C300071 Netherlands   Start Trial PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
0694547 SPC/GB02/027 United Kingdom   Start Trial 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
0694547 SPC028/2002 Ireland   Start Trial SPC028/2002: 20040929, EXPIRES: 20160919
0694547 0290023-1 Sweden   Start Trial PRODUCT NAME:VALGANCIKLOVIR
0694547 2002/028 Ireland   Start Trial 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
0694547 CA 2002 00021 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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