Requip Xl is a drug owned by Glaxosmithkline Llc. 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 Dec 02, 2021. Details of Requip Xl'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). | |||
| US7927624 | Hydrophilic/lipophilic polymeric matrix dosage formulation |
Dec, 2021
(3 years ago) |
Expired
|
| US8303986 | Hydrophilic/lipophilic polymeric matrix dosage formulation |
Apr, 2021
(3 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Requip Xl's patents.
Latest Legal Activities on Requip Xl's Patents
Given below is the list of recent legal activities going on the following patents of Requip Xl.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 24 Jun, 2024 | US8303986 |
| Expire Patent Critical | 22 May, 2023 | US7927624 |
| Maintenance Fee Reminder Mailed Critical | 05 Dec, 2022 | US7927624 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Apr, 2020 | US8303986 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Oct, 2018 | US7927624 |
| Recordation of Patent Grant Mailed Critical | 06 Nov, 2012 | US8303986 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Nov, 2012 | US8303986 |
| Email Notification Critical | 18 Oct, 2012 | US8303986 |
| Issue Notification Mailed Critical | 17 Oct, 2012 | US8303986 |
| Dispatch to FDC | 02 Oct, 2012 | US8303986 |
FDA has granted several exclusivities to Requip Xl. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Requip Xl, 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 Requip Xl.
Exclusivity Information
Requip Xl holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Requip Xl's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-203) | Mar 23, 2020 |
US patents provide insights into the exclusivity only within the United States, but Requip Xl 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 Requip Xl's family patents as well as insights into ongoing legal events on those patents.
Requip Xl's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Requip Xl's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 02, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Requip Xl Generic API suppliers:
Ropinirole Hydrochloride is the generic name for the brand Requip Xl. 18 different companies have already filed for the generic of Requip Xl, with Chartwell Rx having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Requip Xl's generic
How can I launch a generic of Requip Xl before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Requip Xl's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Requip Xl'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 Requip Xl -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2 mg | 14 Oct, 2008 | 1 | 17 May, 2012 | 06 Jun, 2012 | Eligible |
| 4 mg | 31 Oct, 2008 | 1 | 17 May, 2012 | 06 Jun, 2012 | Eligible |
| 6 mg | 14 Jul, 2009 | 1 | 17 May, 2012 | 06 Jun, 2012 | Eligible |
| 8 mg | 03 Nov, 2008 | 1 | 17 May, 2012 | 06 Jun, 2012 | Eligible |
| 3 mg | 08 Jan, 2009 | 1 | 06 Jun, 2012 | Extinguished | |
| 12 mg | 05 Feb, 2009 | 1 | 17 May, 2012 | 06 Jun, 2012 | Eligible |
Alternative Brands for Requip Xl
Requip Xl which is used for treating Parkinson's syndrome., has several other brand drugs in the same treatment category . 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 | Treatment Area | ||
|---|---|---|---|---|
| Supernus Pharms |
| |||
About Requip Xl
Requip Xl is a drug owned by Glaxosmithkline Llc. It is used for treating Parkinson's syndrome. Requip Xl uses Ropinirole Hydrochloride as an active ingredient. Requip Xl was launched by Glaxosmithkline Llc in 2008.
Approval Date:
Requip Xl was approved by FDA for market use on 13 June, 2008.
Active Ingredient:
Requip Xl uses Ropinirole Hydrochloride as the active ingredient. Check out other Drugs and Companies using Ropinirole Hydrochloride ingredient
Treatment:
Requip Xl is used for treating Parkinson's syndrome.
Dosage:
Requip Xl is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |