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Last Updated: May 20, 2022

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-one 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical dosage forms comprising valganciclovir hydrochloride
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hoffmann La Roche VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304-001 Mar 29, 2001 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 See Plans and Pricing See Plans and Pricing
>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
China 1045089 See Plans and Pricing
Japan H0841061 2-(2-AMINO-1,6-DIHYDRO-6-OXOPURIN-9-YL)METHOXY-1, 3-PROPANEDIOL DERIVATIVE See Plans and Pricing
Poland 2101733 See Plans and Pricing
Portugal 2101733 See Plans and Pricing
Ukraine 93599 ПОРОШКОПОДІБНИЙ ПРЕПАРАТ ВАЛГАНЦИКЛОВІРУ[Порошкообразный препарат валганцикловира (powder valgancyclovir preparation) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VALCYTE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0694547 0290023-1 Sweden See Plans and Pricing PRODUCT NAME:VALGANCIKLOVIR
0694547 03C0003 France See Plans and Pricing 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 91136 Luxembourg See Plans and Pricing 91136, EXPIRES: 20160920
0694547 SPC/GB02/027 United Kingdom See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Dow
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McKinsey
Mallinckrodt
Harvard Business School

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