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Rotigotine - Generic Drug Details

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What are the generic sources for rotigotine and what is the scope of rotigotine patent protection?

Rotigotine is the generic ingredient in one branded drug marketed by Ucb Inc and is included in one NDA. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rotigotine has one hundred and fifty-seven patent family members in thirty-seven countries.

There are seven drug master file entries for rotigotine. One supplier is listed for this compound.

Summary for rotigotine

International Patents:	157
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Suppliers / Packagers:	1
Bulk Api Vendors:	61
Clinical Trials:	74
Patent Applications:	164
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rotigotine
DailyMed Link:	rotigotine at DailyMed

Synonyms for rotigotine

(-)-(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)-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)-

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

D05768

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

MolPort-005-941-578

N 0437, (-)-isomer

N 0923

N-0923

NCGC00168748-01

NCGC00168748-02

Neupro

Neupro (TN)

PubChem16423

RL06136

Rotigotine (JAN/USAN/INN)

Rotigotine [USAN:INN:BAN]

Rotigotine [USAN:INN]

Rotigotine CDS

Rotigotine CDS Patch

RT-015446

s4274

SB19528

SC-22242

SCHEMBL1088585

SPM 962

SPM-936

SPM-937

SPM-962

SS-4572

SW220014-1

Tox21_112627

Tox21_112627_1

UNII-5QTR54Z0E1 component KFQYTPMOWPVWEJ-INIZCTEOSA-N

UNII-87T4T8BO2E

W-5179

ZINC4028

US Patents and Regulatory Information for rotigotine

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	021829-005	Apr 2, 2012		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	021829-001	May 9, 2007		RX	Yes	Yes			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
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012		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 rotigotine

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
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-001	May 9, 2007
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-002	May 9, 2007
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-005	Apr 2, 2012
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-006	Apr 2, 2012

International Patents for rotigotine

Country	Patent Number	Estimated Expiration
China	1402633
Israel	138722
Israel	149812
China	1671375
Hungary	0101519
Japan	3984785
Germany	10054713

Supplementary Protection Certificates for rotigotine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1033978	24/2006	Austria		PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 - EU/1/05/331/013 20060215
1033978	CA 2006 00020	Denmark		PRODUCT NAME: ROTIGOTINE
1033978	SZ 24/2006	Austria		PRODUCT NAME: ROTIGOTINE
1033978	06C0025	France		PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 20060215
1033978	C01033978/01	Switzerland		TEILUEBERTRAGUNG
1033978	SPC/GB06/023	United Kingdom		SPC/GB06/023: 20070702, EXPIRES: 20210214
1033978	91269	Luxembourg		91269, EXPIRES: 20210215