Propecia is a drug owned by Organon Llc A Sub Of Organon And Co. It is protected by 3 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 05, 2013. Details of Propecia'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). | |||
| US5571817 | Methods of treating androgenic alopecia with finasteride [17β-N-mono-substituted-carbamoyl-4-aza-5-α-androst-1-en-ones] |
Nov, 2013
(11 years ago) |
Expired
|
| US5547957 | Method of treating androgenic alopecia with 5-α reductase inhibitors |
Oct, 2013
(11 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 Propecia 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 Propecia's family patents as well as insights into ongoing legal events on those patents.
Propecia's Family Patents
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Generic Launch
Generic Release Date:
Propecia's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 05, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Propecia Generic API suppliers:
Finasteride is the generic name for the brand Propecia. 17 different companies have already filed for the generic of Propecia, 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 Propecia's generic
How can I launch a generic of Propecia before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Propecia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Propecia'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 Propecia -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg |
Alternative Brands for Propecia
Propecia which is used for treating male pattern baldness and androgenic alopecia., 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, Propecia's active ingredient. Check the complete list of approved generic manufacturers for Propecia
About Propecia
Propecia is a drug owned by Organon Llc A Sub Of Organon And Co. It is used for treating male pattern baldness and androgenic alopecia. Propecia uses Finasteride as an active ingredient. Propecia was launched by Organon in 1997.
Approval Date:
Propecia was approved by FDA for market use on 19 December, 1997.
Active Ingredient:
Propecia uses Finasteride as the active ingredient. Check out other Drugs and Companies using Finasteride ingredient
Treatment:
Propecia is used for treating male pattern baldness and androgenic alopecia.
Dosage:
Propecia is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG | TABLET | Prescription | ORAL |