Prozac is a drug owned by Eli Lilly And Co. It is protected by 1 US drug patent 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 Prozac'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6960577 | Combination therapy for treatment of refractory depression |
Nov, 2017
(6 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 Prozac's patents.
Latest Legal Activities on Prozac's Patents
Given below is the list of recent legal activities going on the following patents of Prozac.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation | 01 Nov, 2005 | US6960577 |
| Recordation of Patent Grant Mailed | 01 Nov, 2005 | US6960577 |
| Issue Notification Mailed | 12 Oct, 2005 | US6960577 |
| Receipt into Pubs | 06 Oct, 2005 | US6960577 |
| Dispatch to FDC | 05 Oct, 2005 | US6960577 |
| Application Is Considered Ready for Issue | 13 Aug, 2005 | US6960577 |
| Issue Fee Payment Verified | 05 Jul, 2005 | US6960577 |
| Issue Fee Payment Received | 05 Jul, 2005 | US6960577 |
| Mail Examiner's Amendment | 02 Jun, 2005 | US6960577 |
| Mail Notice of Allowance | 02 Jun, 2005 | US6960577 |
FDA has granted several exclusivities to Prozac. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Prozac, 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 Prozac.
Exclusivity Information
Prozac holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Prozac's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-589) | Mar 19, 2012 |
| New Patient Population(NPP) | Jul 26, 2016 |
US patents provide insights into the exclusivity only within the United States, but Prozac 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 Prozac's family patents as well as insights into ongoing legal events on those patents.
Prozac's family patents
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Generic Launch
Generic Release Date:
Prozac'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)
Prozac Generics:
Fluoxetine Hydrochloride is the generic name for the brand Prozac. 52 different companies have already filed for the generic of Prozac, with Teva Pharms Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Prozac's generic
How can I launch a generic of Prozac before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Prozac's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Prozac'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 Prozac -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg and 20 mg | |||||
| 10 mg, 20 mg and 40 mg | |||||
| 20 mg (base)/5 mL | |||||
| 10 mg and 20 mg |
About Prozac
Prozac is a drug owned by Eli Lilly And Co. It is used for treating treatment-resistant depression in adults. Prozac uses Fluoxetine Hydrochloride as an active ingredient. Prozac was launched by Eli Lilly And Co in 1992.
Market Authorisation Date:
Prozac was approved by FDA for market use on 23 December, 1992.
Active Ingredient:
Prozac uses Fluoxetine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Fluoxetine Hydrochloride ingredient
Treatment:
Prozac is used for treating treatment-resistant depression in adults.
Dosage:
Prozac is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10MG BASE | CAPSULE | Prescription | ORAL |
| EQ 20MG BASE | CAPSULE | Prescription | ORAL |
| EQ 40MG BASE | CAPSULE | Prescription | ORAL |