VALCYTE Drug Patent Profile

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When do Valcyte patents expire, 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 4^th, 2014.

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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:	218
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

Drug patent expirations by year for VALCYTE

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

See all VALCYTE clinical trials

Pharmacology for VALCYTE

Drug Class	Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Nucleoside Analog Antiviral
Mechanism of Action	DNA Polymerase Inhibitors

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

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Glossary

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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

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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 VALCYTE

See the table below for patents covering VALCYTE around the world.

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Country	Patent Number	Title	Estimated Expiration
Cyprus	2180	2-(2Amino-1,6-dihydro-6-oxo-purin-9-yl) methoxy-1,3-propanediol derivative	⤷ Sign Up
Israel	198854	צורה רוקחי מוצקה למתן פומי המכילה ולגנציקלוויר וחומצה פומרית (Solid pharmaceutical dosage form for oral administration comprising valganciclovir and fumaric acid)	⤷ Sign Up
Mexico	2009005921	FORMULACION EN POLVO DEL VALGANCICLOVIR. (POWDER FORMULATION FOR VALGANCICLOVIR.)	⤷ Sign Up
Uruguay	24006	DERIVADO DEL 2-(2-AMINO -1,6-DIHIDRO-6-OXO-PURIN-9-IL)METOXIL-1,3-PROPANODIOL.	⤷ 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

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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	91136	Luxembourg	⤷ Sign Up	91136, EXPIRES: 20160920
0694547	0290023-1	Sweden	⤷ Sign Up	PRODUCT NAME:VALGANCIKLOVIR
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description