VALCYTE Drug Patent Profile
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Which patents cover Valcyte, and when can generic versions of Valcyte launch?
Valcyte is a drug marketed by Cheplapharm and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.
This drug has thirty-six patent family members in thirty-one countries.
The generic ingredient in VALCYTE 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 Valcyte
A generic version of VALCYTE was approved as valganciclovir hydrochloride by DR REDDYS on November 4th, 2014.
Summary for VALCYTE
International Patents: | 36 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 82 |
Clinical Trials: | 41 |
Patent Applications: | 222 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for VALCYTE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VALCYTE |
What excipients (inactive ingredients) are in VALCYTE? | VALCYTE excipients list |
DailyMed Link: | VALCYTE at DailyMed |
Recent Clinical Trials for VALCYTE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Viracta Therapeutics, Inc. | Phase 1/Phase 2 |
Karolinska Institutet | Phase 2 |
Cecilia Soderberg-Naucler | Phase 2 |
Pharmacology for VALCYTE
Drug Class | Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Nucleoside Analog Antiviral |
Mechanism of Action | DNA Polymerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for VALCYTE
Paragraph IV (Patent) Challenges for VALCYTE
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 VALCYTE
VALCYTE is protected by two US patents.
Patents protecting VALCYTE
Pharmaceutical dosage forms comprising valganciclovir hydrochloride
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical dosage forms comprising valganciclovir hydrochloride
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Cheplapharm | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Cheplapharm | VALCYTE | valganciclovir hydrochloride | TABLET;ORAL | 021304-001 | Mar 29, 2001 | AB | RX | Yes | Yes | ⤷ 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 VALCYTE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cheplapharm | VALCYTE | valganciclovir hydrochloride | TABLET;ORAL | 021304-001 | Mar 29, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VALCYTE
See the table below for patents covering VALCYTE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | 9502238 | ⤷ Sign Up | |
Japan | H0841061 | 2-(2-AMINO-1,6-DIHYDRO-6-OXOPURIN-9-YL)METHOXY-1, 3-PROPANEDIOL DERIVATIVE | ⤷ Sign Up |
Norway | 2003001 | ⤷ Sign Up | |
Czech Republic | 290511 | 2-(2-Amino-1,6-dihydro-6-oxopurin-9-yl)methoxy-3-hydroxy-1-propanyl-L-valinát a jeho pouľití, meziprodukt a farmaceutická kompozice (2-(2-Amino-1,6-dihydro-6-oxopurin-9-yl)methoxy-3-hydroxy-1-propanyl-L-valinate and its use, intermediate and pharmaceutical composition) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VALCYTE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0694547 | 91136 | Luxembourg | ⤷ Sign Up | 91136, EXPIRES: 20160920 |
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 | 0290023-1 | Sweden | ⤷ Sign Up | PRODUCT NAME:VALGANCIKLOVIR |
0694547 | CA 2002 00021 | Denmark | ⤷ Sign Up | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |