Prozac Weekly is a drug owned by Eli Lilly And Co. It is protected by 5 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 29, 2017. Details of Prozac Weekly'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). | |||
|
US5910319 (Pediatric) | Fluoxetine enteric pellets and methods for their preparation and use |
Nov, 2017
(7 years ago) |
Expired
|
|
US5985322 (Pediatric) | Method for the treatment of CNS disorders |
Nov, 2017
(7 years ago) |
Expired
|
| USRE39030 | Fluoxetine enteric pellets and methods for their preparation and use |
May, 2017
(7 years ago) |
Expired
|
| US5985322 | Method for the treatment of CNS disorders |
May, 2017
(7 years ago) |
Expired
|
| US5910319 | Fluoxetine enteric pellets and methods for their preparation and use |
May, 2017
(7 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Prozac Weekly 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 Weekly's family patents as well as insights into ongoing legal events on those patents.
Prozac Weekly's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Prozac Weekly's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 29, 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 Weekly Generic API suppliers:
Fluoxetine Hydrochloride is the generic name for the brand Prozac Weekly. 49 different companies have already filed for the generic of Prozac Weekly, with Sciegen Pharms Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Prozac Weekly's generic
How can I launch a generic of Prozac Weekly before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Prozac Weekly's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Prozac Weekly'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 Weekly -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 90 mg |
Alternative Brands for Prozac Weekly
Prozac Weekly which is used for treating depression and minimizing nausea side effects., has several other brand drugs using the same active ingredient (Fluoxetine Hydrochloride). 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fluoxetine Hydrochloride, Prozac Weekly's active ingredient. Check the complete list of approved generic manufacturers for Prozac Weekly
About Prozac Weekly
Prozac Weekly is a drug owned by Eli Lilly And Co. It is used for treating depression and minimizing nausea side effects. Prozac Weekly uses Fluoxetine Hydrochloride as an active ingredient. Prozac Weekly was launched by Lilly in 2001.
Approval Date:
Prozac Weekly was approved by FDA for market use on 26 February, 2001.
Active Ingredient:
Prozac Weekly uses Fluoxetine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Fluoxetine Hydrochloride ingredient
Treatment:
Prozac Weekly is used for treating depression and minimizing nausea side effects.
Dosage:
Prozac Weekly is available in capsule, delayed rel pellets form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED REL PELLETS | Discontinued | ORAL |