Proscar is a drug owned by Organon Llc A Sub Of Organon And Co. It is protected by 2 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 Oct 23, 2018. Details of Proscar'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). | |||
| US5942519 | Prevention of precipitated acute urinary retention |
Oct, 2018
(6 years ago) |
Expired
|
| US5886184 | Finasteride processes |
Nov, 2012
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Proscar 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 Proscar's family patents as well as insights into ongoing legal events on those patents.
Proscar's Family Patents
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Generic Launch
Generic Release Date:
Proscar's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 23, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Proscar Generic API suppliers:
Finasteride is the generic name for the brand Proscar. 17 different companies have already filed for the generic of Proscar, with Hetero Labs Ltd Iii having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Proscar's generic
How can I launch a generic of Proscar before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Proscar's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Proscar'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 Proscar -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg |
Alternative Brands for Proscar
Proscar which is used for treating acute urinary retention in patients., has several other brand drugs using the same active ingredient (Finasteride). 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 | |
|---|---|---|
| Organon |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Finasteride, Proscar's active ingredient. Check the complete list of approved generic manufacturers for Proscar
About Proscar
Proscar is a drug owned by Organon Llc A Sub Of Organon And Co. It is used for treating acute urinary retention in patients. Proscar uses Finasteride as an active ingredient. Proscar was launched by Organon in 1992.
Approval Date:
Proscar was approved by FDA for market use on 19 June, 1992.
Active Ingredient:
Proscar uses Finasteride as the active ingredient. Check out other Drugs and Companies using Finasteride ingredient
Treatment:
Proscar is used for treating acute urinary retention in patients.
Dosage:
Proscar is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | TABLET | Prescription | ORAL |