Ganzyk-rtu is a drug owned by Exela Pharma Sciences Llc. It is protected by 1 US drug patent filed in 2017 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 02, 2034. Details of Ganzyk-rtu'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). | |||
| US9486530 | Ganciclovir compositions and related methods |
Sep, 2034
(7 years from now) | Active |
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 Ganzyk-rtu's patents.
Latest Legal Activities on Ganzyk-rtu's Patents
Given below is the list of recent legal activities going on the following patents of Ganzyk-rtu.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 7.5 yr surcharge - late pmt w/in 6 mo, Small Entity | 08 Nov, 2024 | US9486530 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 08 Nov, 2024 | US9486530 |
| Maintenance Fee Reminder Mailed
Critical | 01 Jul, 2024 | US9486530 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 24 Apr, 2020 | US9486530 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 21 Nov, 2018 | US9486530 |
| Email Notification
Critical | 21 Nov, 2018 | US9486530 |
| Recordation of Patent Grant Mailed
Critical | 08 Nov, 2016 | US9486530 |
| Application ready for PDX access by participating foreign offices
Critical | 08 Nov, 2016 | US9486530 |
| Patent Issue Date Used in PTA Calculation
Critical | 08 Nov, 2016 | US9486530 |
| Email Notification
Critical | 20 Oct, 2016 | US9486530 |
US patents provide insights into the exclusivity only within the United States, but
Ganzyk-rtu 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 Ganzyk-rtu's family patents as well as insights into
ongoing legal events
on those patents.
Ganzyk-rtu's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Ganzyk-rtu:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Ganzyk-rtu's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 02, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ganzyk-rtu Generic API suppliers:
Ganciclovir is the generic name for the brand Ganzyk-rtu. 1 company has already filed for the generic of Ganzyk-rtu. Check out the entire list of companies who have already received approval for Ganzyk-rtu's generic
Alternative Brands for Ganzyk-rtu
There are several other brand drugs using the same active ingredient (Ganciclovir) as Ganzyk-rtu. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Cheplapharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ganciclovir, Ganzyk-rtu's active ingredient. Check the complete list of approved generic manufacturers for Ganzyk-rtu
About Ganzyk-rtu
Ganzyk-Rtu is a drug owned by Exela Pharma Sciences Llc. Ganzyk-Rtu uses Ganciclovir as an active ingredient. Ganzyk-Rtu was launched by Exela in 2017.
Approval Date:
Ganzyk-rtu was approved by FDA for market use on 17 February, 2017.
Active Ingredient:
Ganzyk-rtu uses Ganciclovir as the active ingredient. Check out other Drugs and Companies using Ganciclovir ingredient
Dosage:
Ganzyk-rtu is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG/250ML (2MG/ML) | SOLUTION | Discontinued | INTRAVENOUS |