Zoloft is a drug owned by Viatris Specialty Llc. It is protected by 6 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 Apr 11, 2020. Details of Zoloft'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). | |||
|
US6727283 (Pediatric) | Sertraline oral concentrate |
Apr, 2020
(4 years ago) |
Expired
|
|
US7067555 (Pediatric) | Sertraline oral concentrate |
Apr, 2020
(4 years ago) |
Expired
|
| US7067555 | Sertraline oral concentrate |
Oct, 2019
(5 years ago) |
Expired
|
| US6727283 | Sertraline oral concentrate |
Oct, 2019
(5 years ago) |
Expired
|
|
US5248699 (Pediatric) | Sertraline polymorph |
Feb, 2013
(11 years ago) |
Expired
|
| US5248699 | Sertraline polymorph |
Aug, 2012
(12 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 Zoloft's patents.
Latest Legal Activities on Zoloft's Patents
Given below is the list of recent legal activities going on the following patents of Zoloft.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Nov, 2017 | US7067555 |
| Patent Issue Date Used in PTA Calculation Critical | 27 Jun, 2006 | US7067555 |
| Recordation of Patent Grant Mailed Critical | 27 Jun, 2006 | US7067555 |
| Issue Notification Mailed Critical | 07 Jun, 2006 | US7067555 |
| Dispatch to FDC | 01 Jun, 2006 | US7067555 |
| Application Is Considered Ready for Issue Critical | 04 May, 2006 | US7067555 |
| Mail Examiner's Amendment | 17 Apr, 2006 | US7067555 |
| Pubs Case Remand to TC Critical | 13 Jan, 2006 | US7067555 |
| Issue Fee Payment Received Critical | 07 Nov, 2005 | US7067555 |
| Issue Fee Payment Verified Critical | 07 Nov, 2005 | US7067555 |
US patents provide insights into the exclusivity only within the United States, but Zoloft 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 Zoloft's family patents as well as insights into ongoing legal events on those patents.
Zoloft's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zoloft's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 11, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zoloft Generic API suppliers:
Sertraline Hydrochloride is the generic name for the brand Zoloft. 24 different companies have already filed for the generic of Zoloft, with Heritage Pharma Avet having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zoloft's generic
How can I launch a generic of Zoloft before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zoloft's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zoloft'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 Zoloft -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg/mL | 09 Dec, 2003 | 1 | 30 Jun, 2006 | 11 Oct, 2019 | Eligible |
| 25 mg, 50 mg and 100 mg | |||||
| 150 mg and 200 mg | 09 Nov, 2005 | 1 | 06 Feb, 2007 | 13 Aug, 2012 | Eligible |
About Zoloft
Zoloft is a drug owned by Viatris Specialty Llc. It is used for treating disorders of the serotonergic system such as depression and anxiety-related disorders. Zoloft uses Sertraline Hydrochloride as an active ingredient. Zoloft was launched by Viatris in 1999.
Approval Date:
Zoloft was approved by FDA for market use on 07 December, 1999.
Active Ingredient:
Zoloft uses Sertraline Hydrochloride as the active ingredient. Check out other Drugs and Companies using Sertraline Hydrochloride ingredient
Treatment:
Zoloft is used for treating disorders of the serotonergic system such as depression and anxiety-related disorders.
Dosage:
Zoloft is available in the following dosage forms - tablet form for oral use, concentrate form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE/ML | CONCENTRATE | Prescription | ORAL |
| EQ 100MG BASE | TABLET | Prescription | ORAL |
| EQ 50MG BASE | TABLET | Prescription | ORAL |
| EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 25MG BASE | TABLET | Prescription | ORAL |