Avodart is a drug owned by Waylis Therapeutics Llc. 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 20, 2015. Details of Avodart'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). | |||
| US5565467 | Androstenone derivative |
Nov, 2015
(8 years ago) |
Expired
|
| US5998427 | Androstenones |
Sep, 2013
(11 years ago) |
Expired
|
| US5846976 | Androstenone derivative |
Sep, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Avodart 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 Avodart's family patents as well as insights into ongoing legal events on those patents.
Avodart's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Avodart's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 20, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Avodart Generic API suppliers:
Dutasteride is the generic name for the brand Avodart. 18 different companies have already filed for the generic of Avodart, with Strides Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Avodart's generic
How can I launch a generic of Avodart before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Avodart's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Avodart'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 Avodart -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.5 mg | 29 Oct, 2007 | 1 | 21 Dec, 2010 | 20 Nov, 2015 | Deferred |
Alternative Brands for Avodart
Avodart which is used for treating benign prostatic hyperplasia and other androgen-responsive conditions by inhibiting the 5 alpha testosterone reductase enzyme with dutasteride or its derivatives., has several other brand drugs using the same active ingredient (Dutasteride). 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 | |
|---|---|---|
| Waylis Therap |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Dutasteride, Avodart's active ingredient. Check the complete list of approved generic manufacturers for Avodart
About Avodart
Avodart is a drug owned by Waylis Therapeutics Llc. It is used for treating benign prostatic hyperplasia and other androgen-responsive conditions by inhibiting the 5 alpha testosterone reductase enzyme with dutasteride or its derivatives. Avodart uses Dutasteride as an active ingredient. Avodart was launched by Waylis Therap in 2001.
Approval Date:
Avodart was approved by FDA for market use on 20 November, 2001.
Active Ingredient:
Avodart uses Dutasteride as the active ingredient. Check out other Drugs and Companies using Dutasteride ingredient
Treatment:
Avodart is used for treating benign prostatic hyperplasia and other androgen-responsive conditions by inhibiting the 5 alpha testosterone reductase enzyme with dutasteride or its derivatives.
Dosage:
Avodart is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.5MG | CAPSULE | Prescription | ORAL |