~ Buy the NEUPRO (rotigotine) Drug Profile, 2024 PDF Report in the Report Store ~

NEUPRO Drug Patent Profile

✉ Email this page to a colleague

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

< Available with Subscription >

Try a Trial

Summary for NEUPRO

International Patents:	85
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	39
Patent Applications:	1,527
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

Drug patent expirations by year for NEUPRO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NEUPRO

Generic Entry Date for NEUPRO^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
Virginia Commonwealth University	Phase 2
National Institute on Drug Abuse (NIDA)	Phase 2
Alzheimer's Drug Discovery Foundation	Phase 2

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 six US patents.

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

This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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

Transdermal delivery system
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try a Trial
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	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-006	Apr 2, 2012		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012	⤷ Try a Trial	⤷ Try a Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-005	Apr 2, 2012	⤷ Try a Trial	⤷ Try a Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for NEUPRO

Subscribe to access the full database, or Try a Trial
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.

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Lithuania	2515887		⤷ Try a Trial
Mexico	2012007326	POLIVINILPIRROLIDONA PARA LA ESTABILIZACION DE UNA DISPERSION SOLIDA DE FORMA NO CRISTALINA DE ROTIGOTINA. (POLYVINYLPYRROLIDONE FOR THE STABILIZATION OF A SOLID DISPERSION OF THE NON-CRYSTALLINE FORM OF ROTIGOTINE.)	⤷ Try a Trial
Hungary	228822	TRANSDERMAL THERAPEUTIC SYSTEMS WITH IMPROVED STABILITY AND A METHOD FOR THE PRODUCTION THEREOF	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NEUPRO

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1033978	06C0025	France	⤷ Try a Trial	PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 20060215
1033978	SZ 24/2006	Austria	⤷ Try a Trial	PRODUCT NAME: ROTIGOTINE
1033978	C01033978/01	Switzerland	⤷ Try a Trial	TEILUEBERTRAGUNG
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description