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
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 150 |
| Clinical Trials: | 10 |
| Drug Prices: | Drug price information for CYTOVENE |
| What excipients (inactive ingredients) are in CYTOVENE? | CYTOVENE excipients list |
| DailyMed Link: | CYTOVENE at DailyMed |
Recent Clinical Trials for CYTOVENE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fred Hutchinson Cancer Research Center | Phase 3 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Roche Palo | CYTOVENE | ganciclovir | CAPSULE;ORAL | 020460-002 | Dec 12, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cheplapharm | CYTOVENE | ganciclovir sodium | INJECTABLE;INJECTION | 019661-001 | Jun 23, 1989 | DISCN | Yes | No | ⤷ 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
| Roche Palo | CYTOVENE | ganciclovir | CAPSULE;ORAL | 020460-001 | Dec 22, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Roche Palo | CYTOVENE | ganciclovir | CAPSULE;ORAL | 020460-002 | Dec 12, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Roche Palo | CYTOVENE | ganciclovir | CAPSULE;ORAL | 020460-002 | Dec 12, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Roche Palo | CYTOVENE | ganciclovir | CAPSULE;ORAL | 020460-002 | Dec 12, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Cheplapharm | CYTOVENE | ganciclovir sodium | INJECTABLE;INJECTION | 019661-001 | Jun 23, 1989 | ⤷ Sign Up | ⤷ Sign Up |
| Cheplapharm | CYTOVENE | ganciclovir sodium | INJECTABLE;INJECTION | 019661-001 | Jun 23, 1989 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Czechoslovakia | 235042 | METHOD OF 9-(L1,3- DIHYDROXY-2-PROPOMETHYL ) P-GUANIN PREPARATION | ⤷ Sign Up |
| Hungary | 186514 | PROCESS FOR PRODUCING 6-BRACKET-1,3-DIHYDROXY-2-PROPOXY-METHYL-BRACKET CLOSED-GUANINE | ⤷ Sign Up |
| Hong Kong | 67088 | 9-(1,3-DIHYDROXY-2-PROPOXYMETHYL)-GUANINE AS ANTIVIRAL AGENT | ⤷ Sign Up |
| Japan | H046195 | ⤷ Sign Up | |
| Czechoslovakia | 235018 | METHOD OF 9-/6 1,3-HYDROXY-2-PROPOXYMETHYL/P-GUANINE PREPARATION | ⤷ Sign Up |
| Norway | 161740 | ⤷ Sign Up | |
| Hungary | 188000 | PROCESS FOR PRODUCTION OF N-2 SUBSTITUATED 9-/1,3 DIHYDROXI-2-PROPOXI-METHIL/-GUANINS | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CYTOVENE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0694547 | C300071 | Netherlands | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | 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 |
| 0694547 | SPC/GB02/027 | United Kingdom | ⤷ Sign Up | 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 |
| >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.
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