Rapaflo is a drug owned by Allergan Sales Llc. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Rapaflo's patents have been open to challenges since 08 October, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 01, 2018. Details of Rapaflo'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). | |||
| US5387603 | 1,5,7-trisubstituted indoline compounds and salts thereof |
Dec, 2018
(5 years ago) |
Expired
|
| US5780485 | Use of α1c specific compounds to treat benign prostatic hyperplasia |
Nov, 2012
(12 years ago) |
Expired
|
| US6015819 | Use of alpha-1C specific compounds to treat benign prostatic hyperplasia |
Nov, 2012
(12 years ago) |
Expired
|
| US5403847 | Use of α1C specific compounds to treat benign prostatic hyperlasia |
Nov, 2012
(12 years ago) |
Expired
|
FDA has granted several exclusivities to Rapaflo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rapaflo, 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 Rapaflo.
Exclusivity Information
Rapaflo holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Rapaflo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 08, 2013 |
US patents provide insights into the exclusivity only within the United States, but Rapaflo 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 Rapaflo's family patents as well as insights into ongoing legal events on those patents.
Rapaflo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rapaflo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 01, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rapaflo Generic API suppliers:
Silodosin is the generic name for the brand Rapaflo. 12 different companies have already filed for the generic of Rapaflo, with Ajanta Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Rapaflo's generic
How can I launch a generic of Rapaflo before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Rapaflo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rapaflo'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 Rapaflo -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 4 mg and 8 mg | 09 Oct, 2012 | 3 | 31 Mar, 2017 | 01 Dec, 2018 | Deferred |
About Rapaflo
Rapaflo is a drug owned by Allergan Sales Llc. It is used for managing the signs and symptoms of benign prostatic hyperplasia (BPH). Rapaflo uses Silodosin as an active ingredient. Rapaflo was launched by Allergan in 2008.
Approval Date:
Rapaflo was approved by FDA for market use on 08 October, 2008.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Rapaflo is 08 October, 2008, its NCE-1 date is estimated to be 08 October, 2012.
Active Ingredient:
Rapaflo uses Silodosin as the active ingredient. Check out other Drugs and Companies using Silodosin ingredient
Treatment:
Rapaflo is used for managing the signs and symptoms of benign prostatic hyperplasia (BPH).
Dosage:
Rapaflo is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4MG | CAPSULE | Prescription | ORAL |
| 8MG | CAPSULE | Prescription | ORAL |