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Last Updated: May 17, 2022

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 six 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 ten 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 Generic Entry Opportunity 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
I.R.C.C.S. Fondazione Santa LuciaPhase 2
Alzheimer's Drug Discovery FoundationPhase 2
UCB Biopharma S.P.R.L.Phase 3

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 seven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEUPRO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Transdermal delivery system for the administration of rotigotine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY SYSTEM

Transdermal delivery system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Transdermal delivery system for the administration of rotigotine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR THE TREATMENT OF A PATIENT SUFFERING FROM A DISEASE TREATABLE WITH ROTIGOTINE, COMPRISING APPLYING THE CLAIMED TRANSDERMAL DELIVERY SYSTEM (TDS) TO THE SKIN OF THE PATIENT

Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 021829-006 Apr 2, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-003 May 9, 2007 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-002 May 9, 2007 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 021829-006 Apr 2, 2012 See Plans and Pricing See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-004 Apr 2, 2012 See Plans and Pricing See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-004 Apr 2, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NEUPRO

When does loss-of-exclusivity occur for NEUPRO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 03266252
Estimated Expiration: See Plans and Pricing

Austria

Patent: 3380
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 13092
Estimated Expiration: See Plans and Pricing

Canada

Patent: 90573
Estimated Expiration: See Plans and Pricing

China

Patent: 71365
Estimated Expiration: See Plans and Pricing

Patent: 0558350
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 24971
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 86604
Estimated Expiration: See Plans and Pricing

Patent: 24971
Estimated Expiration: See Plans and Pricing

Germany

Patent: 309329
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 83458
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5917
Estimated Expiration: See Plans and Pricing

Japan

Patent: 37915
Estimated Expiration: See Plans and Pricing

Patent: 05535686
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05000349
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 7476
Estimated Expiration: See Plans and Pricing

Norway

Patent: 4187
Estimated Expiration: See Plans and Pricing

Patent: 050770
Estimated Expiration: See Plans and Pricing

Poland

Patent: 6999
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 24971
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 24971
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0500255
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1016914
Estimated Expiration: See Plans and Pricing

Patent: 050025638
Estimated Expiration: See Plans and Pricing

Spain

Patent: 73042
Estimated Expiration: See Plans and Pricing

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

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

Country Patent Number Title Estimated Expiration
Japan 4837915 See Plans and Pricing
Poland 198323 See Plans and Pricing
Hungary 0203318 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NEUPRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1033978 SZ 24/2006 Austria See Plans and Pricing PRODUCT NAME: ROTIGOTINE
1033978 C300236 Netherlands See Plans and Pricing PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001-013 20060215
1033978 SPC026/2006 Ireland See Plans and Pricing SPC026/2006:, EXPIRES: 20210214
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Medtronic
Express Scripts
Colorcon
Baxter

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.