VALGANCICLOVIR HYDROCHLORIDE - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for valganciclovir hydrochloride and what is the scope of patent protection?
Valganciclovir hydrochloride
is the generic ingredient in two branded drugs marketed by Cheplapharm, 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 seventeen NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Valganciclovir hydrochloride has thirty-six patent family members in thirty-one countries.
There are seventeen drug master file entries for valganciclovir hydrochloride. Twenty-four suppliers are listed for this compound.
Summary for VALGANCICLOVIR HYDROCHLORIDE
International Patents: | 36 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 13 |
NDAs: | 17 |
Drug Master File Entries: | 17 |
Finished Product Suppliers / Packagers: | 24 |
Raw Ingredient (Bulk) Api Vendors: | 82 |
Clinical Trials: | 109 |
Patent Applications: | 307 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VALGANCICLOVIR HYDROCHLORIDE |
What excipients (inactive ingredients) are in VALGANCICLOVIR HYDROCHLORIDE? | VALGANCICLOVIR HYDROCHLORIDE excipients list |
DailyMed Link: | VALGANCICLOVIR HYDROCHLORIDE at DailyMed |
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 |
Takeda | Phase 4 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd V | VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | TABLET;ORAL | 205166-001 | Mar 18, 2016 | AB | RX | 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 | |||
Dr Reddys | VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | TABLET;ORAL | 203511-001 | Nov 4, 2014 | 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 | |||
Msn | VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 210169-001 | Feb 17, 2022 | 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 |
Expired US Patents for VALGANCICLOVIR HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cheplapharm | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | VALCYTE | valganciclovir hydrochloride | TABLET;ORAL | 021304-001 | Mar 29, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VALGANCICLOVIR HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2101733 | PRÉPARATION EN POUDRE DU VALGANCICLOVIR (POWDER FORMULATION FOR VALGANCICLOVIR) | ⤷ Sign Up |
Taiwan | I341730 | ⤷ Sign Up | |
Brazil | PI0720118 | FORMULAÇÃO EM PÓ PARA VALGANCICLOVIR | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2008071573 | ⤷ Sign Up | |
Morocco | 31280 | تحضير مسحوق الفالجاسيكلوفير. | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VALGANCICLOVIR HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0694547 | 2002/028 | Ireland | ⤷ Sign Up | PRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013 |
0694547 | C300071 | Netherlands | ⤷ Sign Up | PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920 |
0694547 | SPC/GB02/027 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: 2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)-METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE HYDROCHLORIDE (VALGANCICLOVIR HYDROCHLORIDE); REGISTERED: NL RVG 25992 20010920; UK PL 00031/0599 20020425 |
0694547 | 03C0003 | France | ⤷ Sign Up | PRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.