Valcyte Patent Expiration

Valcyte is a drug owned by Cheplapharm Arzneimittel Gmbh. It is protected by 4 US drug patents filed from 2013 to 2018. Out of these, 2 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 11, 2027. Details of Valcyte's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9642911 Pharmaceutical dosage forms comprising valganciclovir hydrochloride
Dec, 2027

(3 years from now)

Active
US8889109 Pharmaceutical dosage forms comprising valganciclovir hydrochloride
Dec, 2027

(3 years from now)

Active
US6083953

(Pediatric)

2- (2-amino-1,6-dihydro-6-oxo-purin-9-yl) methoxy-1,3- propanediol derivative
Sep, 2015

(9 years ago)

Expired
US6083953 2- (2-amino-1,6-dihydro-6-oxo-purin-9-yl) methoxy-1,3- propanediol derivative
Mar, 2015

(9 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Valcyte's patents.

Given below is the list of recent legal activities going on the following patents of Valcyte.

Activity Date Patent Number
Patent litigations
Email Notification 30 Aug, 2022 US9642911
Change in Power of Attorney (May Include Associate POA) 30 Aug, 2022 US9642911
Correspondence Address Change 26 Aug, 2022 US9642911
Change in Power of Attorney (May Include Associate POA) 25 Aug, 2022 US8889109
Correspondence Address Change 24 Aug, 2022 US8889109
Payment of Maintenance Fee, 8th Year, Large Entity 12 Apr, 2022 US8889109
Payment of Maintenance Fee, 4th Year, Large Entity 28 Sep, 2020 US9642911
Surcharge for Late Payment, Large Entity 21 Aug, 2018 US8889109
Payment of Maintenance Fee, 4th Year, Large Entity 21 Aug, 2018 US8889109
Maintenance Fee Reminder Mailed 02 Jul, 2018 US8889109


FDA has granted several exclusivities to Valcyte. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Valcyte, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Valcyte.

Exclusivity Information

Valcyte holds 6 exclusivities. All of its exclusivities have expired in 2018. Details of Valcyte's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-604) Aug 28, 2012
New Dosage Form(NDF) Aug 28, 2012
Pediatric Exclusivity(PED) Feb 28, 2013
New Dosing Schedule(D-125) Aug 05, 2013
New Dosing Schedule(D-148) Apr 23, 2018
New Patient Population(NPP) Apr 23, 2018

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US patents provide insights into the exclusivity only within the United States, but Valcyte is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Valcyte's family patents as well as insights into ongoing legal events on those patents.

Valcyte's Family Patents

Valcyte has patent protection in a total of 31 countries. It's US patent count contributes only to 20.5% of its total global patent coverage. 5 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Valcyte.

Family Patents

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Generic Launch

Generic Release Date:

Valcyte's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 11, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Valcyte Generic API suppliers:

Valganciclovir Hydrochloride is the generic name for the brand Valcyte. 13 different companies have already filed for the generic of Valcyte, with Ajanta Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Valcyte's generic

How can I launch a generic of Valcyte before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Valcyte's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Valcyte's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Valcyte -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
50 mg/mL 21 Mar, 2011 1 29 Mar, 2015 Extinguished
450 mg 27 Dec, 2005 1 28 Jul, 2014 Extinguished





About Valcyte

Valcyte is a drug owned by Cheplapharm Arzneimittel Gmbh. It is used for preventing CMV disease in high-risk kidney, heart, and kidney-pancreas transplant patients. Valcyte uses Valganciclovir Hydrochloride as an active ingredient. Valcyte was launched by Cheplapharm in 2009.

Approval Date:

Valcyte was approved by FDA for market use on 28 August, 2009.

Active Ingredient:

Valcyte uses Valganciclovir Hydrochloride as the active ingredient. Check out other Drugs and Companies using Valganciclovir Hydrochloride ingredient

Treatment:

Valcyte is used for preventing CMV disease in high-risk kidney, heart, and kidney-pancreas transplant patients.

Dosage:

Valcyte is available in the following dosage forms - tablet form for oral use, for solution form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
50MG/ML FOR SOLUTION Prescription ORAL
EQ 450MG BASE TABLET Prescription ORAL