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Last Updated: January 15, 2021

DrugPatentWatch Database Preview

GANCICLOVIR - Generic Drug Details

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What are the generic drug sources for ganciclovir and what is the scope of freedom to operate?

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

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

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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
Ranbaxy Labs Ltd GANCICLOVIR ganciclovir CAPSULE;ORAL 076457-002 Jun 27, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Bausch And Lomb ZIRGAN ganciclovir GEL;OPHTHALMIC 022211-001 Sep 15, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Hainan Poly Pharm GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204204-001 Nov 8, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 076222-001 Jul 16, 2003 DISCN No 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
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
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:

Baxter
Mallinckrodt
Merck
Express Scripts
McKinsey
Colorcon

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