Kytril is a drug owned by Hoffmann La Roche Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 14, 2016. Details of Kytril'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). | |||
| US5952340 | Use of granisetron for the treatment of postoperative nausea and vomiting |
Sep, 2016
(8 years ago) |
Expired
|
FDA has granted several exclusivities to Kytril. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kytril, 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 Kytril.
Exclusivity Information
Kytril holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Kytril's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-102) | Apr 29, 2014 |
US patents provide insights into the exclusivity only within the United States, but Kytril 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 Kytril's family patents as well as insights into ongoing legal events on those patents.
Kytril's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Kytril's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 14, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kytril Generic API suppliers:
Granisetron Hydrochloride is the generic name for the brand Kytril. 28 different companies have already filed for the generic of Kytril, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Kytril's generic
How can I launch a generic of Kytril before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Kytril's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kytril'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 Kytril -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.1 mg/mL, 1 mL single dose vial | 08 Mar, 2007 | 1 | |||
| 1 mg/mL, 1 mL vials | 01 Jun, 2004 | 1 | 31 Dec, 2007 | 04 May, 2019 | Eligible |
| 1 mg/mL, 4 mL multi-dose vials | 19 Jul, 2004 | 1 | 31 Dec, 2007 | 04 May, 2019 | Eligible |
About Kytril
Kytril is a drug owned by Hoffmann La Roche Inc. It is used for managing post-operative nausea and vomiting. Kytril uses Granisetron Hydrochloride as an active ingredient. Kytril was launched by Roche in 2004.
Approval Date:
Kytril was approved by FDA for market use on 17 September, 2004.
Active Ingredient:
Kytril uses Granisetron Hydrochloride as the active ingredient. Check out other Drugs and Companies using Granisetron Hydrochloride ingredient
Treatment:
Kytril is used for managing post-operative nausea and vomiting.
Dosage:
Kytril is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |
| EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |
| EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |