Symbyax 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 Nov 01, 2017. Details of Symbyax'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
|
| US5945416 | Method for treating pain |
Mar, 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 Symbyax's patents.
Latest Legal Activities on Symbyax's Patents
Given below is the list of recent legal activities going on the following patents of Symbyax.
| 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 Symbyax. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Symbyax, 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 Symbyax.
Exclusivity Information
Symbyax holds 3 exclusivities. All of its exclusivities have expired in 2017. Details of Symbyax's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-593) | Mar 19, 2012 |
| New Patient Population(NPP) | Jul 26, 2016 |
| M(M-142) | Oct 10, 2017 |
US patents provide insights into the exclusivity only within the United States, but Symbyax 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 Symbyax's family patents as well as insights into ongoing legal events on those patents.
Symbyax's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Symbyax'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)
Symbyax Generic API suppliers:
Fluoxetine Hydrochloride; Olanzapine is the generic name for the brand Symbyax. 3 different companies have already filed for the generic of Symbyax, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Symbyax's generic
How can I launch a generic of Symbyax before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Symbyax's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Symbyax'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 Symbyax -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 6 mg/25 mg 12 mg/25 mg 6 mg/50 mg 12 mg/50 mg | 10 Jan, 2005 | 1 | 20 Jun, 2012 | 01 Nov, 2017 | Extinguished |
About Symbyax
Symbyax is a drug owned by Eli Lilly And Co. It is used for acute treatment of treatment-resistant depression in adults. Symbyax uses Fluoxetine Hydrochloride; Olanzapine as an active ingredient. Symbyax was launched by Lilly in 2007.
Approval Date:
Symbyax was approved by FDA for market use on 09 April, 2007.
Active Ingredient:
Symbyax uses Fluoxetine Hydrochloride; Olanzapine as the active ingredient. Check out other Drugs and Companies using Fluoxetine Hydrochloride; Olanzapine ingredient
Treatment:
Symbyax is used for acute treatment of treatment-resistant depression in adults.
Dosage:
Symbyax is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 25MG BASE;EQ 3MG BASE | CAPSULE | Prescription | ORAL |
| EQ 25MG BASE;EQ 6MG BASE | CAPSULE | Prescription | ORAL |
| EQ 50MG BASE;EQ 12MG BASE | CAPSULE | Prescription | ORAL |
| EQ 50MG BASE;EQ 6MG BASE | CAPSULE | Prescription | ORAL |
| EQ 25MG BASE;EQ 12MG BASE | CAPSULE | Prescription | ORAL |