Pristiq is a drug owned by Pf Prism Cv. It is protected by 2 US drug patents filed from 2013 to 2015. Out of these, 1 drug patents are active and 1 has expired. Pristiq's patents have been open to challenges since 01 March, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 05, 2027. Details of Pristiq's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8269040 | Derivatives of venlafaxine and methods of preparing and using the same |
Jul, 2027
(2 years from now) | Active |
| US6673838 | Succinate salt of O-desmethyl-venlafaxine |
Mar, 2022
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6673838 | Succinate salt of O-desmethyl-venlafaxine |
Feb, 2022
(2 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 Pristiq's patents.
Latest Legal Activities on Pristiq's Patents
Given below is the list of recent legal activities going on the following patents of Pristiq.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Feb, 2024 | US8269040 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Feb, 2020 | US8269040 (Litigated) |
| Patent Term Extension Certificate Critical | 26 Mar, 2014 | US6673838 (Litigated) |
| Notice of Final Determination -Eligible | 25 Sep, 2013 | US6673838 (Litigated) |
| Email Notification Critical | 17 Oct, 2012 | US6673838 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 17 Oct, 2012 | US6673838 (Litigated) |
| Resp. to req. for info. sent under 37 CFR 1.750 | 27 Sep, 2012 | US6673838 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 18 Sep, 2012 | US8269040 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 18 Sep, 2012 | US8269040 (Litigated) |
| Email Notification Critical | 30 Aug, 2012 | US8269040 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Pristiq and ongoing litigations to help you estimate the early arrival of Pristiq generic.
Pristiq's Litigations
Pristiq been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 28, 2010, against patent number US6673838. The petitioner , challenged the validity of this patent, with Anthony F. Hadfield et al as the respondent. Click below to track the latest information on how companies are challenging Pristiq's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6673838 | May, 2010 |
Decision
(28 May, 2010) | Anthony F. Hadfield et al | |
FDA has granted some exclusivities to Pristiq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pristiq, 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 Pristiq.
Exclusivity Information
Pristiq holds 3 exclusivities. All of its exclusivities have expired in 2021. Details of Pristiq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 01, 2013 |
| New Indication(I-675) | Feb 14, 2016 |
| M(M-222) | Feb 06, 2021 |
Several oppositions have been filed on Pristiq's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Pristiq's generic, the next section provides detailed information on ongoing and past EP oppositions related to Pristiq patents.
Pristiq's Oppositions Filed in EPO
Pristiq has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 08, 2008, by Sepracor Inc. This opposition was filed on patent number EP02718949A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP04010248A | Mar, 2009 | Lammert, Roland, Dr. | Revoked |
| EP04010248A | Mar, 2009 | Wyeth | Revoked |
| EP04010248A | Mar, 2009 | RANBAXY PHARMACEUTICALS INC. | Revoked |
| EP02718949A | May, 2008 | EGIS Gyógyszergyár Nyrt | Patent maintained as amended |
| EP02718949A | May, 2008 | Lammert, Roland, Dr. | Patent maintained as amended |
| EP02718949A | May, 2008 | SEPRACOR Inc | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Pristiq 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 Pristiq's family patents as well as insights into ongoing legal events on those patents.
Pristiq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pristiq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 05, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pristiq Generic API suppliers:
Desvenlafaxine Succinate is the generic name for the brand Pristiq. 9 different companies have already filed for the generic of Pristiq, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Pristiq's generic
How can I launch a generic of Pristiq before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Pristiq's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pristiq'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 Pristiq -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg and 100 mg | 29 Feb, 2012 | 12 | 29 Jun, 2015 | 11 Feb, 2022 | Eligible |
| 25 mg | 08 May, 2015 | 1 | 29 Jul, 2016 | 05 Jul, 2027 | Eligible |
About Pristiq
Pristiq is a drug owned by Pf Prism Cv. It is used for treating depression, including maintenance treatment of major depressive disorder. Pristiq uses Desvenlafaxine Succinate as an active ingredient. Pristiq was launched by Pf Prism Cv in 2014.
Approval Date:
Pristiq was approved by FDA for market use on 20 August, 2014.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Pristiq is 20 August, 2014, its NCE-1 date is estimated to be 01 March, 2012.
Active Ingredient:
Pristiq uses Desvenlafaxine Succinate as the active ingredient. Check out other Drugs and Companies using Desvenlafaxine Succinate ingredient
Treatment:
Pristiq is used for treating depression, including maintenance treatment of major depressive disorder.
Dosage:
Pristiq is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 25MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 50MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 100MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |