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Last Updated: January 19, 2020

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GANCICLOVIR Drug Profile

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Which patents cover Ganciclovir, and what generic alternatives are available?

Ganciclovir is a drug marketed by Ranbaxy Labs Ltd, 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 nine NDAs.

The generic ingredient in GANCICLOVIR is ganciclovir sodium. There are twenty-seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Ganciclovir

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A generic version of GANCICLOVIR was approved as ganciclovir sodium by FRESENIUS KABI USA on January 19th, 2020.

Drug patent expirations by year for GANCICLOVIR
Drug Prices for GANCICLOVIR

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Recent Clinical Trials for GANCICLOVIR

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

SponsorPhase
Horizon 2020 - European CommissionPhase 1/Phase 2
MolMed S.p.A.Phase 1/Phase 2
Maimónides Biomedical Research Institute of CórdobaPhase 3

See all GANCICLOVIR clinical trials

Recent Litigation for GANCICLOVIR

Identify potential future generic entrants

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

See all GANCICLOVIR litigation

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 076457-001 Jun 27, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204560-001 Nov 17, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 090658-001 Jun 21, 2010 AP RX No No   Start Trial   Start Trial   Start Trial
Par Sterile Products GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204950-001 Dec 6, 2016 AP RX 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

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Serving leading biopharmaceutical companies globally:

Dow
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McKinsey
Colorcon
Medtronic

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