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Last Updated: September 27, 2020

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Ganciclovir - Generic Drug Details

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What are the generic drug sources for ganciclovir and what is the scope of patent protection?

Ganciclovir is the generic ingredient in six branded drugs marketed by Roche Palo, Ranbaxy Labs Ltd, Bausch And Lomb, Exela Pharma, Cheplapharm, Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hainan Poly Pharm, Mylan Labs Ltd, Par Sterile Products, Pharmascience Inc, and West-ward Pharms Int, and is included in fourteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for ganciclovir. Two suppliers are listed for this compound.

Drug Prices for ganciclovir

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Recent Clinical Trials for ganciclovir

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

SponsorPhase
Peking University People's HospitalPhase 1/Phase 2
Horizon 2020 - European CommissionPhase 1/Phase 2
MolMed S.p.A.Phase 1/Phase 2

See all ganciclovir clinical trials

Medical Subject Heading (MeSH) Categories for ganciclovir
Paragraph IV (Patent) Challenges for GANCICLOVIR
Tradename Dosage Ingredient NDA Submissiondate
CYTOVENE CAPSULE;ORAL ganciclovir 020460

US Patents and Regulatory Information for ganciclovir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204560-001 Nov 17, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Exela Pharma GANZYK-RTU ganciclovir SOLUTION;INTRAVENOUS 209347-001 Feb 17, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Custopharm Inc GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 212001-001 Jun 20, 2019 DISCN No 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
>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 ganciclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-001 Dec 22, 1994   Start Trial   Start Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997   Start Trial   Start Trial
Bausch And Lomb VITRASERT ganciclovir IMPLANT;IMPLANTATION 020569-001 Mar 4, 1996   Start Trial   Start Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997   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:

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Boehringer Ingelheim

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