VALGANCICLOVIR HYDROCHLORIDE Drug Patent Profile
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When do Valganciclovir Hydrochloride patents expire, and when can generic versions of Valganciclovir Hydrochloride launch?
Valganciclovir Hydrochloride is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Granules, Hetero Labs Ltd V, MSN, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Mylan, and Strides Pharma. and is included in fifteen NDAs.
The generic ingredient in VALGANCICLOVIR HYDROCHLORIDE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Valganciclovir Hydrochloride
A generic version of VALGANCICLOVIR HYDROCHLORIDE was approved as valganciclovir hydrochloride by DR REDDYS on November 4th, 2014.
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Summary for VALGANCICLOVIR HYDROCHLORIDE
![VALGANCICLOVIR HYDROCHLORIDE drug patent expirations Drug patent expirations by year for VALGANCICLOVIR HYDROCHLORIDE](/p/graph/s/t/VALGANCICLOVIR_HYDROCHLORIDE-patent-expirations.png)
Recent Clinical Trials for VALGANCICLOVIR HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Pennsylvania | Phase 2 |
Merck Sharp & Dohme LLC | Phase 2 |
MERCK SHARP & DOHME DE ESPAÑA S.A. | Phase 2 |
Pharmacology for VALGANCICLOVIR HYDROCHLORIDE
Drug Class | Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Nucleoside Analog Antiviral |
Mechanism of Action | DNA Polymerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for VALGANCICLOVIR HYDROCHLORIDE
Paragraph IV (Patent) Challenges for VALGANCICLOVIR HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
VALCYTE | for Oral Solution | valganciclovir hydrochloride | 50 mg/mL | 022257 | 1 | 2011-03-21 |
VALCYTE | Tablets | valganciclovir hydrochloride | 450 mg | 021304 | 1 | 2005-12-27 |
US Patents and Regulatory Information for VALGANCICLOVIR HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actavis Labs Fl Inc | VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 205220-001 | Jul 18, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Msn | VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 210169-001 | Feb 17, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma | VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 215124-001 | Nov 17, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys | VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | TABLET;ORAL | 206876-001 | Dec 12, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ajanta Pharma Ltd | VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | TABLET;ORAL | 212234-001 | Dec 26, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan | VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | TABLET;ORAL | 205151-001 | Mar 3, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ajanta Pharma Ltd | VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 212890-001 | Jan 13, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |