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Last Updated: March 29, 2024

CYTOVENE Drug Patent Profile


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Which patents cover Cytovene, and what generic alternatives are available?

Cytovene is a drug marketed by Roche Palo and Cheplapharm and is included in two NDAs.

The generic ingredient in CYTOVENE is ganciclovir sodium. There are twenty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cytovene

A generic version of CYTOVENE was approved as ganciclovir sodium by HIKMA on July 16th, 2003.

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Summary for CYTOVENE
Drug patent expirations by year for CYTOVENE
Drug Prices for CYTOVENE

See drug prices for CYTOVENE

Recent Clinical Trials for CYTOVENE

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

SponsorPhase
National Heart, Lung, and Blood Institute (NHLBI)Phase 3
Fred Hutchinson Cancer Research CenterPhase 3
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1

See all CYTOVENE clinical trials

US Patents and Regulatory Information for CYTOVENE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-001 Dec 22, 1994 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 DISCN Yes No ⤷  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 CYTOVENE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-001 Dec 22, 1994 ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 ⤷  Try a Trial ⤷  Try a Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997 ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 ⤷  Try a Trial ⤷  Try a Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997 ⤷  Try a Trial ⤷  Try a Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-001 Dec 22, 1994 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for CYTOVENE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH.. Vitrasert Implant ganciclovir EMEA/H/C/000120
The Vitrasert implant is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) (See 4.4. Special warnings and special precautions for use).
Withdrawn no no no 1997-03-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for CYTOVENE

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

Country Patent Number Title Estimated Expiration
German Democratic Republic 213218 VERFAHREN ZUR HERSTELLUNG VON 9-(1,3-DIHYDROXY-2-PROPOXYMETHYL)-GUANINDERIVATEN ⤷  Try a Trial
Spain 8500276 ⤷  Try a Trial
Poland 242100 ⤷  Try a Trial
Spain 524899 ⤷  Try a Trial
Czechoslovakia 235043 METHOD OF 9-(L1,3-DIHYDROXY-2-PROPOXYMETHYL)P-GUANIN PREPARATION ⤷  Try a Trial
India 160603 A PROCESS FOR THE PREPARATION OF 9-(1,3-DIHYDROXY-2-PROPOXYMETHYL)GUANINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF ⤷  Try a Trial
India 156469 PROCESS FOR THE PREPARATION OF 9-(1,3-DIHYDROXY-2-PROPOXYMETHYL) GUANINE AND PHARMACEUTICALLY ACCEPTABLE SALT THEREFOR ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CYTOVENE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 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 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
>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.