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Last Updated: May 28, 2024

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 Cheplapharm 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-four 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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical dosage forms comprising valganciclovir hydrochloride
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

International Patents for VALCYTE

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

Country Patent Number Title Estimated Expiration
Germany 69509173 ⤷  Sign Up
Ukraine 93599 ПОРОШКОПОДІБНИЙ ПРЕПАРАТ ВАЛГАНЦИКЛОВІРУ[Порошкообразный препарат валганцикловира (powder valgancyclovir preparation) ⤷  Sign Up
Norway 952977 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VALCYTE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0694547 SPC028/2002 Ireland ⤷  Sign Up SPC028/2002: 20040929, EXPIRES: 20160919
0694547 CA 2002 00021 Denmark ⤷  Sign Up
0694547 2002/028 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.