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Last Updated: July 26, 2021

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Details for Patent: 8,889,109


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Which drugs does patent 8,889,109 protect, and when does it expire?

Patent 8,889,109 protects VALCYTE and is included in one NDA.

This patent has thirty-six patent family members in thirty-one countries.

Summary for Patent: 8,889,109
Title:Pharmaceutical dosage forms comprising valganciclovir hydrochloride
Abstract: The present invention provides novel solid pharmaceutical dosage forms for oral administration, after being constituted in water. The solid dosage forms comprise a therapeutically effective amount of valganciclovir hydrochloride and a non-hygroscopic organic acid present in an amount sufficient to stabilize the valganciclovir hydrochloride in a predetermined amount of water. The present invention also provides novel liquid pharmaceutical dosage forms for oral administration after constituting the solid pharmaceutical dosage form with water. A non-hygroscopic bulking agent may optionally be included in the above dosage form. These novel pharmaceutical dosage forms are useful in the treatment or control of viruses such as herpes simplex virus and cytomegalovirus. The present invention also provides a method for treating these diseases employing the solid and liquid pharmaceutical dosage forms and a method for preparing these pharmaceutical dosage forms.
Inventor(s): Bachynsky; Maria Oksana (Nutley, NJ), Infeld; Martin Howard (Upper Montclair, NJ), Shah; Navnit Hargovindas (Clifton, NJ)
Assignee: Hoffman-La Roche Inc. (Nutley, NJ)
Application Number:13/759,348
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,889,109
Patent Claim Types:
see list of patent claims
Composition; Dosage form;

Drugs Protected by US Patent 8,889,109

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Hoffmann La Roche VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257-001 Aug 28, 2009 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,889,109

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 065541 ⤷  Free Forever Trial
Australia 2007332640 ⤷  Free Forever Trial
Brazil PI0720118 ⤷  Free Forever Trial
Canada 2671470 ⤷  Free Forever Trial
Chile 2007003564 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Baxter
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McKesson
AstraZeneca

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