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Last Updated: May 28, 2024

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NEUPRO Drug Patent Profile


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Which patents cover Neupro, and what generic alternatives are available?

Neupro is a drug marketed by Ucb Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-five patent family members in twenty-nine countries.

The generic ingredient in NEUPRO is rotigotine. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rotigotine profile page.

DrugPatentWatch® Generic Entry Outlook for Neupro

Neupro was eligible for patent challenges on May 9, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 1, 2032. This may change due to patent challenges or generic licensing.

There have been twelve patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for NEUPRO
Drug Prices for NEUPRO

See drug prices for NEUPRO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NEUPRO
Generic Entry Date for NEUPRO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FILM, EXTENDED RELEASE;TRANSDERMAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for NEUPRO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute on Drug Abuse (NIDA)Phase 2
Virginia Commonwealth UniversityPhase 2
Alzheimer's Drug Discovery FoundationPhase 2

See all NEUPRO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for NEUPRO
Paragraph IV (Patent) Challenges for NEUPRO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NEUPRO Extended-release Transdermal Film rotigotine 1 mg/24 hr 2 mg/24 hr 3 mg/24 hr 4 mg/24 hr 6 mg/24 hr 8 mg/24 hr 021829 1 2013-11-26

US Patents and Regulatory Information for NEUPRO

NEUPRO is protected by six US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEUPRO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting NEUPRO

Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Transdermal delivery system for the administration of rotigotine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF PARKINSON'S DISEASE BY APPLICATION OF CLAIMED TRANSDERMAL SYSTEM

Transdermal delivery system for the administration of rotigotine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY SYSTEM

Transdermal delivery system
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-003 May 9, 2007 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-006 Apr 2, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-003 May 9, 2007 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NEUPRO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-002 May 9, 2007 ⤷  Sign Up ⤷  Sign Up
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-005 Apr 2, 2012 ⤷  Sign Up ⤷  Sign Up
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-002 May 9, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for NEUPRO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
UCB Pharma S.A.   Leganto rotigotine EMEA/H/C/002380
Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.Leganto is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations).
Withdrawn no no no 2011-06-16
UCB Pharma S.A. Neupro rotigotine EMEA/H/C/000626
Parkinson's disease: Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations).Restless-legs syndrome: Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.
Authorised no no no 2006-02-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for NEUPRO

See the table below for patents covering NEUPRO around the world.

Country Patent Number Title Estimated Expiration
Spain 2256780 ⤷  Sign Up
Germany 59900581 ⤷  Sign Up
European Patent Office 3257504 POLYVINYLPYRROLIDONE POUR LA STABILISATION D'UNE DISPERSION SOLIDE DE FORME NON CRISTALLINE DE ROTIGOTINE (POLYVINYLPYRROLIDONE FOR THE STABILIZATION OF A SOLID DISPERSION OF THE NON-CRYSTALLINE FORM OF ROTIGOTINE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NEUPRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1033978 SPC026/2006 Ireland ⤷  Sign Up SPC026/2006:, EXPIRES: 20210214
1033978 CA 2006 00020 Denmark ⤷  Sign Up PRODUCT NAME: ROTIGOTINE
1033978 24/2006 Austria ⤷  Sign Up PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 - EU/1/05/331/013 20060215
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.