Neupro is a drug owned by Ucb Inc. It is protected by 9 US drug patents filed from 2013 to 2019. Out of these, 5 drug patents are active and 4 have expired. Neupro's patents have been open to challenges since 10 May, 2011. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 01, 2032. Details of Neupro'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). | |||
| US9925150 | Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine |
Mar, 2032
(6 years from now) | Active |
| US10130589 | Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine |
Dec, 2030
(5 years from now) | Active |
| US10350174 | Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine |
Dec, 2030
(5 years from now) | Active |
| US8246979 | Transdermal delivery system for the administration of rotigotine |
Sep, 2027
(2 years from now) | Active |
| US8246980 | Transdermal delivery system |
Nov, 2025
(4 months from now) | Active |
| US8617591 | Transdermal delivery system for the administration of rotigotine |
Jul, 2023
(1 year, 11 months ago) |
Expired
|
| US6884434 | Transdermal therapeutic system which contains a d2 agonist and which is provided for treating parkinsonism, and a method for the production thereof |
Mar, 2021
(4 years ago) |
Expired
|
| US6699498 | Transdermal therapeutic systems having improved stability and their production |
Nov, 2020
(4 years ago) |
Expired
|
| US7413747 | Transdermal therapeutic system for treating Parkinsonism |
Mar, 2019
(6 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 Neupro's patents.
Latest Legal Activities on Neupro's Patents
Given below is the list of recent legal activities going on the following patents of Neupro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Court Processing Terminated | 16 Apr, 2024 | US8246980 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 Feb, 2024 | US8246980 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 Feb, 2024 | US8246979 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Jan, 2023 | US10350174 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 04 May, 2022 | US10130589 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Sep, 2021 | US9925150 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jun, 2021 | US8617591 |
| Expire Patent Critical | 21 Sep, 2020 | US7413747 |
| Maintenance Fee Reminder Mailed Critical | 06 Apr, 2020 | US7413747 |
| Post Issue Communication - Certificate of Correction | 21 Feb, 2020 | US8246979 |
FDA has granted several exclusivities to Neupro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Neupro, 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 Neupro.
Exclusivity Information
Neupro holds 3 exclusivities. All of its exclusivities have expired in 2015. Details of Neupro's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 09, 2012 |
| New Indication(I-646) | Apr 02, 2015 |
| New Indication(I-647) | Apr 02, 2015 |
Several oppositions have been filed on Neupro's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Neupro's generic, the next section provides detailed information on ongoing and past EP oppositions related to Neupro patents.
Neupro's Oppositions Filed in EPO
Neupro has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 04, 2019, by Luye Supply Ag. This opposition was filed on patent number EP10796399A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10796399A | Mar, 2019 | Generics [U.K.] Limited | Opposition rejected |
| EP10796399A | Mar, 2019 | Luye Supply AG | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Neupro 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 Neupro's family patents as well as insights into ongoing legal events on those patents.
Neupro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Neupro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 01, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Neupro Generics:
There are no approved generic versions for Neupro as of now.
How can I launch a generic of Neupro before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Neupro's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Neupro'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 Neupro -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/24 hr 2 mg/24 hr 3 mg/24 hr 4 mg/24 hr 6 mg/24 hr 8 mg/24 hr | 26 Nov, 2013 | 1 | 01 Sep, 2027 |
About Neupro
Neupro is a drug owned by Ucb Inc. It is used for treating restless legs syndrome and Parkinson's disease symptoms with transdermal delivery of rotigotine. Neupro uses Rotigotine as an active ingredient. Neupro was launched by Ucb Inc in 2012.
Approval Date:
Neupro was approved by FDA for market use on 02 April, 2012.
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 Neupro is 02 April, 2012, its NCE-1 date is estimated to be 10 May, 2011.
Active Ingredient:
Neupro uses Rotigotine as the active ingredient. Check out other Drugs and Companies using Rotigotine ingredient
Treatment:
Neupro is used for treating restless legs syndrome and Parkinson's disease symptoms with transdermal delivery of rotigotine.
Dosage:
Neupro is available in film, extended release form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 6MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 4MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 2MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 1MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 8MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |