Gemzar is a drug owned by Eli Lilly And Co. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 07, 2013. Details of Gemzar'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). | |||
|
US5464826 (Pediatric) | Method of treating tumors in mammals with 2',2'-difluoronucleosides |
May, 2013
(11 years ago) |
Expired
|
| US5464826 | Method of treating tumors in mammals with 2',2'-difluoronucleosides |
Nov, 2012
(12 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Gemzar 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 Gemzar's family patents as well as insights into ongoing legal events on those patents.
Gemzar's Family Patents
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Generic Launch
Generic Release Date:
Gemzar's generic launch date based on the expiry of its last outstanding patent is estimated to be May 07, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gemzar Generic API suppliers:
Gemcitabine Hydrochloride is the generic name for the brand Gemzar. 25 different companies have already filed for the generic of Gemzar, with Shilpa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Gemzar's generic
How can I launch a generic of Gemzar before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Gemzar's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Gemzar'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 Gemzar -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 mg/vial | 01 Nov, 2005 | 1 | 18 Dec, 2008 | 07 Nov, 2012 | Eligible |
| 1g/vial | 14 Nov, 2005 | 1 | 25 Jan, 2011 | 07 Nov, 2012 | Eligible |
Alternative Brands for Gemzar
Gemzar which is used for treating cancer in mammals., has several other brand drugs using the same active ingredient (Gemcitabine Hydrochloride). 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 | |
|---|---|---|
| Sun Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Gemcitabine Hydrochloride, Gemzar's active ingredient. Check the complete list of approved generic manufacturers for Gemzar
About Gemzar
Gemzar is a drug owned by Eli Lilly And Co. It is used for treating cancer in mammals. Gemzar uses Gemcitabine Hydrochloride as an active ingredient. Gemzar was launched by Lilly in 1996.
Approval Date:
Gemzar was approved by FDA for market use on 15 May, 1996.
Active Ingredient:
Gemzar uses Gemcitabine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Gemcitabine Hydrochloride ingredient
Treatment:
Gemzar is used for treating cancer in mammals.
Dosage:
Gemzar is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |
| EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |