Valganciclovir hydrochloride - Generic Drug Details
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What are the generic sources for valganciclovir hydrochloride and what is the scope of freedom to operate?
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: | 103 |
Patent Applications: | 311 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Viracor Eurofins | Phase 2 |
NYU Langone Health | Phase 2 |
Trellis Bioscience LLC | Phase 1 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cheplapharm | VALCYTE | valganciclovir hydrochloride | TABLET;ORAL | 021304-001 | Mar 29, 2001 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Actavis Labs Fl Inc | VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 205220-001 | Jul 18, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Strides Pharma | VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | TABLET;ORAL | 200790-001 | Nov 4, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Cheplapharm | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Hetero Labs Ltd V | VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | TABLET;ORAL | 205166-001 | Mar 18, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 valganciclovir hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cheplapharm | VALCYTE | valganciclovir hydrochloride | TABLET;ORAL | 021304-001 | Mar 29, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
Cheplapharm | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for valganciclovir hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Serbia | 52457 | PRAŠKASTA FORMULACIJA ZA VALGANCIKLOVIR (POWDER FORMULATION FOR VALGANCICLOVIR) | ⤷ Try a Trial |
China | 101541310 | Powder formulation for valganciclovir | ⤷ Try a Trial |
Morocco | 31280 | تحضير مسحوق الفالجاسيكلوفير. | ⤷ Try a Trial |
Taiwan | I341730 | ⤷ Try a Trial | |
Croatia | P20121033 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for valganciclovir hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0694547 | 03C0003 | France | ⤷ Try a Trial | 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 |
0694547 | SPC/GB02/027 | United Kingdom | ⤷ Try a Trial | 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 | C300071 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920 |
0694547 | 2002/028 | Ireland | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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