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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Serving leading biopharmaceutical companies globally:

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AstraZeneca
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Moodys
Baxter

Last Updated: November 19, 2019

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Ganciclovir - Generic Drug Details

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What are the generic 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 Scs Llc, Cheplapharm, Custopharm Inc, Fresenius Kabi Usa, Hainan Poly Pharm, Luitpold, 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
Horizon 2020 - European CommissionPhase 1/Phase 2
MolMed S.p.A.Phase 1/Phase 2
Instituto de Salud Carlos IIIPhase 3

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Recent Litigation for ganciclovir

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District Court Litigation
Case NameDate
SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC.2015-01-16
Boston Scientific Corporation v. Johnson and Johnson Inc.2007-06-01
Abbott Laboratories v. Johnson and Johnson Inc.2007-05-15

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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
Luitpold GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 202624-001 Sep 18, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Ranbaxy Labs Ltd GANCICLOVIR ganciclovir CAPSULE;ORAL 076457-002 Jun 27, 2003 DISCN 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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
AstraZeneca
Johnson and Johnson
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