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Last Updated: June 9, 2023

VALCYTE Drug Patent 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. Twenty-two suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

Paragraph IV (Patent) Challenges for VALCYTE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VALCYTE for Oral Solution valganciclovir hydrochloride 50 mg/mL 022257 1 2011-03-21
VALCYTE Tablets valganciclovir hydrochloride 450 mg 021304 1 2005-12-27

US Patents and Regulatory Information for VALCYTE

VALCYTE is protected by two US patents.

Patents protecting VALCYTE

Pharmaceutical dosage forms comprising valganciclovir hydrochloride
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical dosage forms comprising valganciclovir hydrochloride
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

International Patents for VALCYTE

See the table below for patents covering VALCYTE around the world.

Country Patent Number Title Estimated Expiration
New Zealand 272652 MONO-L-VALINE GANCICLOVIR; 9-SUBSTITUTED PURINE INTERMEDIATE AND MEDICAMENTS ⤷  Try a Trial
Cyprus 2180 2-(2Amino-1,6-dihydro-6-oxo-purin-9-yl) methoxy-1,3-propanediol derivative ⤷  Try a Trial
Canada 2671470 PREPARATION EN POUDRE DU VALGANCICLOVIR (POWDER FORMULATION FOR VALGANCICLOVIR) ⤷  Try a Trial
Norway 312899 ⤷  Try a Trial
Greece 960300021 ⤷  Try a Trial
South Korea 20090086469 POWDER FORMULATION FOR VALGANCICLOVIR ⤷  Try a Trial
Malaysia 152540 POWDER FORMULATION FOR VALGANCICLOVIR ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VALCYTE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0694547 03C0003 France ⤷  Try a 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 0290023-1 Sweden ⤷  Try a Trial PRODUCT NAME:VALGANCIKLOVIR
0694547 2002/028 Ireland ⤷  Try a 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 SPC/GB02/027 United Kingdom ⤷  Try a 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 C300071 Netherlands ⤷  Try a 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 SPC028/2002 Ireland ⤷  Try a Trial SPC028/2002: 20040929, EXPIRES: 20160919
0694547 91136 Luxembourg ⤷  Try a Trial 91136, EXPIRES: 20160920
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Dow
Merck
McKinsey
Mallinckrodt
Harvard Business School

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 verification 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.