NEUPRO Drug Patent Profile

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

Summary for NEUPRO

International Patents:	85
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	38
Patent Applications:	1,921
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NEUPRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEUPRO
What excipients (inactive ingredients) are in NEUPRO?	NEUPRO excipients list
DailyMed Link:	NEUPRO at DailyMed

See drug prices for NEUPRO

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for NEUPRO

NDA:

021829

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

Sponsor	Phase
I.R.C.C.S. Fondazione Santa Lucia	Phase 2
Alzheimer's Drug Discovery Foundation	Phase 2
UCB Biopharma S.P.R.L.	Phase 3

See all NEUPRO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for NEUPRO

N04BC	Dopamine agonists
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

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.

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

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			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007		RX	Yes	No			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-002	May 9, 2007		RX	Yes	No			Y

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
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012

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

Austria

Brazil

Canada

China

Denmark

European Patent Office

Germany

Hong Kong

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

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
Poland	198323
Hungary	0203318

Supplementary Protection Certificates for NEUPRO

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