Zyprexa 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'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's patents.
Latest Legal Activities on Zyprexa's Patents
Given below is the list of recent legal activities going on the following patents of Zyprexa.
| 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. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zyprexa, 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.
Exclusivity Information
Zyprexa holds 3 exclusivities. All of its exclusivities have expired in 2013. Details of Zyprexa'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 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's family patents as well as insights into ongoing legal events on those patents.
Zyprexa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zyprexa'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 Generic API suppliers:
Olanzapine is the generic name for the brand Zyprexa. 31 different companies have already filed for the generic of Zyprexa, 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's generic
How can I launch a generic of Zyprexa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zyprexa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zyprexa'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg | |||||
| 20 mg |
Alternative Brands for Zyprexa
Zyprexa which is used for treating treatment-resistant depression in adults., has several other brand drugs in the same treatment category and 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 | Treatment Area | ||
|---|---|---|---|---|
| Eli Lilly And Co |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Olanzapine. Given below is the list of those drugs and companies owning them.
| 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's active ingredient. Check the complete list of approved generic manufacturers for Zyprexa
About Zyprexa
Zyprexa is a drug owned by Cheplapharm Registration Gmbh. It is used for treating treatment-resistant depression in adults. Zyprexa uses Olanzapine as an active ingredient. Zyprexa was launched by Cheplapharm in 1996.
Approval Date:
Zyprexa was approved by FDA for market use on 30 September, 1996.
Active Ingredient:
Zyprexa uses Olanzapine as the active ingredient. Check out other Drugs and Companies using Olanzapine ingredient
Treatment:
Zyprexa is used for treating treatment-resistant depression in adults.
Dosage:
Zyprexa is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 7.5MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |
| 15MG | TABLET | Prescription | ORAL |
| 20MG | TABLET | Prescription | ORAL |
| 2.5MG | TABLET | Prescription | ORAL |
| 5MG | TABLET | Prescription | ORAL |