Fetzima is a drug owned by Abbvie Inc. It is protected by 3 US drug patents filed from 2013 to 2014 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 23, 2032. Details of Fetzima'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. | |||
| US8865937 | Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide |
May, 2032
(7 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8481598 | Stable dosage forms of levomilnacipran |
Mar, 2031
(5 years from now) | Active |
| USRE43879 | Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug |
Jan, 2026
(7 months from now) | Active |
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 Fetzima's patents.
Latest Legal Activities on Fetzima's Patents
Given below is the list of recent legal activities going on the following patents of Fetzima.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Mar, 2022 | US8865937 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Jan, 2021 | US8481598 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Apr, 2018 | US8865937 |
| Recordation of Patent Grant Mailed Critical | 21 Oct, 2014 | US8865937 |
| Patent Issue Date Used in PTA Calculation Critical | 21 Oct, 2014 | US8865937 |
| Email Notification Critical | 03 Oct, 2014 | US8865937 |
| Issue Notification Mailed Critical | 01 Oct, 2014 | US8865937 |
| Email Notification Critical | 22 Sep, 2014 | US8865937 |
| Mail Response to 312 Amendment (PTO-271) Critical | 22 Sep, 2014 | US8865937 |
| Dispatch to FDC | 19 Sep, 2014 | US8865937 |
FDA has granted several exclusivities to Fetzima. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Fetzima, 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 Fetzima.
Exclusivity Information
Fetzima holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Fetzima's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| NCE*(NCE*) | Jul 25, 2018 |
| M(M-249) | Oct 07, 2022 |
| M(M-304) | Mar 24, 2026 |
US patents provide insights into the exclusivity only within the United States, but Fetzima 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 Fetzima's family patents as well as insights into ongoing legal events on those patents.
Fetzima's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fetzima's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 23, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fetzima Generic API suppliers:
Levomilnacipran Hydrochloride is the generic name for the brand Fetzima. 4 different companies have already filed for the generic of Fetzima, with Amneal Pharms Co having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fetzima's generic
How can I launch a generic of Fetzima before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fetzima's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fetzima'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 Fetzima -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg, 40 mg, 80 mg and 120 mg | 25 Jul, 2017 | 6 | 04 Feb, 2019 | 02 Mar, 2031 | Eligible |
Alternative Brands for Fetzima
Fetzima which is used for treating Major Depressive Disorder (MDD)., 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 |
| |||
| Astrazeneca |
| |||
| Osmotica Pharm Us |
| |||
| Otsuka |
| |||
About Fetzima
Fetzima is a drug owned by Abbvie Inc. It is used for treating Major Depressive Disorder (MDD). Fetzima uses Levomilnacipran Hydrochloride as an active ingredient. Fetzima was launched by Abbvie in 2013.
Approval Date:
Fetzima was approved by FDA for market use on 25 July, 2013.
Active Ingredient:
Fetzima uses Levomilnacipran Hydrochloride as the active ingredient. Check out other Drugs and Companies using Levomilnacipran Hydrochloride ingredient
Treatment:
Fetzima is used for treating Major Depressive Disorder (MDD).
Dosage:
Fetzima is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 120MG BASE | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| EQ 80MG BASE | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| EQ 20MG BASE | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| EQ 40MG BASE | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |