Neupro Patent Expiration

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

(7 years from now)

Active
US10130589 Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Dec, 2030

(6 years from now)

Active
US10350174 Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Dec, 2030

(6 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

(1 year, 1 month from now)

Active
US8617591 Transdermal delivery system for the administration of rotigotine
Jul, 2023

(1 year, 2 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

(3 years ago)

Expired
US6699498 Transdermal therapeutic systems having improved stability and their production
Nov, 2020

(3 years ago)

Expired
US7413747 Transdermal therapeutic system for treating Parkinsonism
Mar, 2019

(5 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.

Given below is the list of recent legal activities going on the following patents of Neupro.

Activity Date Patent Number
Patent litigations
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 21 Sep, 2020 US7413747
Maintenance Fee Reminder Mailed 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

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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
Patent litigations
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

Neupro has patent protection in a total of 29 countries. It's US patent count contributes only to 13.3% of its total global patent coverage. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Neupro.

Family Patents

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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 2007.

Approval Date:

Neupro was approved by FDA for market use on 09 May, 2007.

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 09 May, 2007, 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
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
6MG/24HR FILM, EXTENDED RELEASE Prescription TRANSDERMAL