Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

CYTOVENE Drug Profile

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Which patents cover Cytovene, and when can generic versions of Cytovene launch?

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. Seven suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.

Drug patent expirations by year for CYTOVENE
Drug Prices for CYTOVENE

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Recent Clinical Trials for CYTOVENE

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SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1
Johns Hopkins Bloomberg School of Public HealthPhase 2/Phase 3
Baylor College of MedicinePhase 2/Phase 3

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Recent Litigation for CYTOVENE

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District Court Litigation
Case NameDate
ROCHE PALO ALTO LLC v. RANBAXY LABORATORIES LIMITED2006-04-28

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Paragraph IV (Patent) Challenges for CYTOVENE
Tradename Dosage Ingredient NDA Submissiondate
CYTOVENE CAPSULE;ORAL ganciclovir 020460

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

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Serving leading biopharmaceutical companies globally:

Moodys
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