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
(2 years from now) | Active |
| US8889109 | Pharmaceutical dosage forms comprising valganciclovir hydrochloride |
Dec, 2027
(2 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
(10 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.
Latest 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 |
|---|---|---|
 | ||
| Email Notification Critical | 30 Aug, 2022 | US9642911 |
| Change in Power of Attorney (May Include Associate POA) Critical | 30 Aug, 2022 | US9642911 |
| Correspondence Address Change Critical | 26 Aug, 2022 | US9642911 |
| Change in Power of Attorney (May Include Associate POA) Critical | 25 Aug, 2022 | US8889109 |
| Correspondence Address Change Critical | 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 Critical | 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 |
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
Explore Our Curated Drug Screens
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. 14 different companies have already filed for the generic of Valcyte, with Hetero Labs Ltd V 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 - for solution form for oral use, tablet 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 |