Zyprexa Zydis is a drug owned by Cheplapharm Registration Gmbh. 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 Nov 01, 2017. Details of Zyprexa Zydis'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). | |||
| US6960577 | Combination therapy for treatment of refractory depression |
Nov, 2017
(7 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 Zyprexa Zydis's patents.
Latest Legal Activities on Zyprexa Zydis's Patents
Given below is the list of recent legal activities going on the following patents of Zyprexa Zydis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation Critical | 01 Nov, 2005 | US6960577 |
| Recordation of Patent Grant Mailed Critical | 01 Nov, 2005 | US6960577 |
| Issue Notification Mailed Critical | 12 Oct, 2005 | US6960577 |
| Receipt into Pubs | 06 Oct, 2005 | US6960577 |
| Dispatch to FDC | 05 Oct, 2005 | US6960577 |
| Application Is Considered Ready for Issue Critical | 13 Aug, 2005 | US6960577 |
| Issue Fee Payment Verified Critical | 05 Jul, 2005 | US6960577 |
| Issue Fee Payment Received Critical | 05 Jul, 2005 | US6960577 |
| Mail Examiner's Amendment | 02 Jun, 2005 | US6960577 |
| Mail Notice of Allowance Critical | 02 Jun, 2005 | US6960577 |
FDA has granted several exclusivities to Zyprexa Zydis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zyprexa Zydis, 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 Zyprexa Zydis.
Exclusivity Information
Zyprexa Zydis holds 3 exclusivities. All of its exclusivities have expired in 2013. Details of Zyprexa Zydis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-591) | Mar 19, 2012 |
| New Patient Population(NPP) | Dec 04, 2012 |
| Pediatric Exclusivity(PED) | Jun 04, 2013 |
US patents provide insights into the exclusivity only within the United States, but Zyprexa Zydis 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 Zyprexa Zydis's family patents as well as insights into ongoing legal events on those patents.
Zyprexa Zydis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zyprexa Zydis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 01, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zyprexa Zydis Generic API suppliers:
Olanzapine is the generic name for the brand Zyprexa Zydis. 31 different companies have already filed for the generic of Zyprexa Zydis, with Ajanta Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zyprexa Zydis's generic
How can I launch a generic of Zyprexa Zydis before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zyprexa Zydis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zyprexa Zydis'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 Zyprexa Zydis -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg, 10 mg, 15 mg and 20 mg |
Alternative Brands for Zyprexa Zydis
Zyprexa Zydis which is used for treating treatment-resistant depression in adults., has several other brand drugs using the same active ingredient (Olanzapine). 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 | ||
|---|---|---|---|
| Alkermes Inc |
| ||
| Cheplapharm |
| ||
| Lilly |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Olanzapine, Zyprexa Zydis's active ingredient. Check the complete list of approved generic manufacturers for Zyprexa Zydis
About Zyprexa Zydis
Zyprexa Zydis is a drug owned by Cheplapharm Registration Gmbh. It is used for treating treatment-resistant depression in adults. Zyprexa Zydis uses Olanzapine as an active ingredient. Zyprexa Zydis was launched by Cheplapharm in 2000.
Approval Date:
Zyprexa Zydis was approved by FDA for market use on 06 April, 2000.
Active Ingredient:
Zyprexa Zydis uses Olanzapine as the active ingredient. Check out other Drugs and Companies using Olanzapine ingredient
Treatment:
Zyprexa Zydis is used for treating treatment-resistant depression in adults.
Dosage:
Zyprexa Zydis is available in tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | TABLET, ORALLY DISINTEGRATING | Prescription | ORAL |
| 5MG | TABLET, ORALLY DISINTEGRATING | Prescription | ORAL |
| 10MG | TABLET, ORALLY DISINTEGRATING | Prescription | ORAL |
| 15MG | TABLET, ORALLY DISINTEGRATING | Prescription | ORAL |