Seroquel Xr is a drug owned by Astrazeneca Uk Ltd. 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 28, 2017. Details of Seroquel Xr'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). | |||
|
US5948437 (Pediatric) | Pharmaceutical compositions using thiazepine |
Nov, 2017
(7 years ago) |
Expired
|
| US5948437 | Pharmaceutical compositions using thiazepine |
May, 2017
(7 years ago) |
Expired
|
FDA has granted several exclusivities to Seroquel Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Seroquel Xr, 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 Seroquel Xr.
Exclusivity Information
Seroquel Xr holds 6 exclusivities. All of its exclusivities have expired in 2012. Details of Seroquel Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-117) | Oct 08, 2011 |
| New Indication(I-574) | Oct 08, 2011 |
| New Indication(I-575) | Oct 08, 2011 |
| New Indication(I-576) | Oct 08, 2011 |
| Pediatric Exclusivity(PED) | Apr 08, 2012 |
| New Indication(I-618) | Dec 02, 2012 |
US patents provide insights into the exclusivity only within the United States, but Seroquel Xr 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 Seroquel Xr's family patents as well as insights into ongoing legal events on those patents.
Seroquel Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Seroquel Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 28, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Seroquel Xr Generic API suppliers:
Quetiapine Fumarate is the generic name for the brand Seroquel Xr. 28 different companies have already filed for the generic of Seroquel Xr, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Seroquel Xr's generic
How can I launch a generic of Seroquel Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Seroquel Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Seroquel Xr'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 Seroquel Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 400 mg | 18 Jun, 2008 | 1 | 01 Nov, 2016 | 28 May, 2017 | Eligible |
| 150 mg | 17 Nov, 2008 | 1 | 09 May, 2017 | 28 May, 2017 | Eligible |
| 200 mg and 300 mg | 12 Jun, 2008 | 1 | 09 May, 2017 | 28 May, 2017 | Eligible |
| 50 mg | 17 Oct, 2008 | 1 | 09 May, 2017 | 28 May, 2017 | Eligible |
Alternative Brands for Seroquel Xr
Seroquel Xr which is used for treating major depressive disorder (MDD) and schizophrenia., has several other brand drugs in the same treatment category . 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 | ||||
|---|---|---|---|---|---|---|
| Abbvie |
| |||||
| Intra-cellular |
| |||||
| Osmotica Pharm Us |
| |||||
| Otsuka |
| |||||
| Otsuka Pharm Co Ltd |
| |||||
About Seroquel Xr
Seroquel Xr is a drug owned by Astrazeneca Uk Ltd. It is used for treating major depressive disorder (MDD) and schizophrenia. Seroquel Xr uses Quetiapine Fumarate as an active ingredient. Seroquel Xr was launched by Astrazeneca in 2007.
Approval Date:
Seroquel Xr was approved by FDA for market use on 17 May, 2007.
Active Ingredient:
Seroquel Xr uses Quetiapine Fumarate as the active ingredient. Check out other Drugs and Companies using Quetiapine Fumarate ingredient
Treatment:
Seroquel Xr is used for treating major depressive disorder (MDD) and schizophrenia.
Dosage:
Seroquel Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 200MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 300MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 400MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 150MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |