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NEUPRO Drug 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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-seven patent family members in thirty-two 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.

Summary for NEUPRO

International Patents:	127
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	58
Clinical Trials:	34
Patent Applications:	113
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NEUPRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEUPRO
DailyMed Link:	NEUPRO at DailyMed

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.

Synonyms for NEUPRO

(-)-(S)-5,6,7,8-Tetrahydro-6-(propyl(2-(2-thienyl)ethyl)amino)-1-naphthol

(-)-N-0437

(2S)-2-[propyl-[2-(2-thienyl)ethyl]amino]tetralin-5-ol

(6S)-6-(propyl-(2-thiophen-2-ylethyl)amino)-5,6,7,8-tetrahydronaphthalen-1-ol

(6S)-6-(Propyl(2-(2-thienyl)ethyl)amino)-5,6,7,8-tetrahydro-1-naphthalenol

(6S)-6-[propyl(2-thiophen-2-ylethyl)amino]-5,6,7,8-tetrahydronaphthalen-1-ol

(S)-(-)-Rotigotine

(S)-5,6,7,8-Tetrahydro-6-(propyl(2-(2-thienyl)ethyl)amino)-1-naphthol

(S)-5,6,7,8-tetrahydro-6-[propyl[2-(2-thienyl)ethyl]amino]-1-naphthol

(S)-6-(propyl(2-(thiophen-2-yl)ethyl)amino)-5,6,7,8-tetrahydronaphthalen-1-ol

(S)-6-[Propyl-(2-thiophen-2-yl-ethyl)-amino]-5,6,7,8-tetrahydro-naphthalen-1-ol

1-naphthalenol, 5,6,7,8-tetrahydro-6-(propyl (2-(2-thienyl)ethyl)amino-(6S)-

1-Naphthalenol, 5,6,7,8-tetrahydro-6-[propyl[2-(2-thienyl)ethyl]amino]-, (6S)-

2-(N-n-Propyl-N-2-thienylethylamino)-5-hydroxytetralin

2696AH

572R932

87T4T8BO2E

99755-59-6

A846076

AB0088886

AC-3547

AC1L1QQG

AJ-08188

AKOS016340728

AN-12885

API0026245

BC677693

BDBM50123626

C19H25NOS

CAS-99755-59-6

CHEBI:135351

CHEMBL1303

CS-0376

CTK8E7903

Cyclopentylcytosine

D05768

D08XAW

D09OQV

DB05271

DSSTox_CID_26772

DSSTox_GSID_46772

DSSTox_RID_81893

DTXSID5046772

EX-A1164

FT-0771906

GTPL941

HSDB 8254

HY-75502

J-502471

KFQYTPMOWPVWEJ-INIZCTEOSA-N

KS-00002WXX

Leganto

LS-178435

MFCD00870193

MolPort-005-941-578

N 0437

N 0437, (-)-isomer

N 0923

N-0437

N-0923

NCGC00168748-01

NCGC00168748-02

Neupro (TN)

PubChem16423

RL06136

Rotigotine

Rotigotine (JAN/USAN/INN)

Rotigotine (USAN/INN)

Rotigotine [USAN:INN:BAN]

Rotigotine [USAN:INN]

Rotigotine CDS

Rotigotine CDS Patch

RT-015446

s4274

SC-22242

SCHEMBL1088585

SPM 962

SPM-936

SPM-937

SPM-962

SS-4572

Tox21_112627

Tox21_112627_1

UNII-5QTR54Z0E1 component KFQYTPMOWPVWEJ-INIZCTEOSA-N

UNII-87T4T8BO2E

W-5179

ZINC4028

US Patents and Regulatory Information for 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	021829-002	May 9, 2007		RX	Yes	No			Y
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	021829-002	May 9, 2007		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

Paragraph IV (Patent) Challenges for NEUPRO

Drugname	Dosage	Strength	RLD	Date
	Extended-release Transdermal Film	1 mg/24 hr, 2 mg/24 hr, 3 mg/24 hr,4 mg/24 hr,6 mg/24 hr, and 8 mg/24 hr

International Patents for NEUPRO

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9949852
Russian Federation	2266735
South Korea	101016838
Slovakia	284618
Brazil	0313091
Australia	779523

Supplementary Protection Certificates for NEUPRO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0025	France		PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 20060215
2006 00020	Denmark		PRODUCT NAME: ROTIGOTINE
/2006	Austria		PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 - EU/1/05/331/013 20060215
24/2006	Austria		PRODUCT NAME: ROTIGOTINE
C026/2006	Ireland		SPC026/2006:, EXPIRES: 20210214
1033978/01	Switzerland		TEILUEBERTRAGUNG