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Last Updated: October 20, 2019

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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 patent protection?

Rotigotine is the generic ingredient in one branded drug marketed by Ucb Inc and is included in one NDA. There are nine 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:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Suppliers / Packagers:	1
Bulk Api Vendors:	64
Clinical Trials:	75
Patent Applications:	169
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rotigotine
DailyMed Link:	rotigotine at DailyMed

Recent Clinical Trials for rotigotine

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Sponsor	Phase
UCB Biopharma S.P.R.L.	Phase 3
UCB Biopharma S.P.R.L.	Phase 4
Johns Hopkins University	Phase 4

See all rotigotine clinical trials

Recent Litigation for rotigotine

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District Court Litigation

Case Name	Date
UCB, Inc. v. Mylan Technologies, Inc.	2017-03-24
UCB Inc. v. Zydus Worldwide DMCC	2016-11-03
UCB Inc. v. Watson Laboratories Inc. (NV)	2014-08-21

See all rotigotine litigation

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

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Glossary

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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	021829-001	May 9, 2007		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-002	May 9, 2007		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-006	Apr 2, 2012		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-001	May 9, 2007		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012		RX	Yes	No	Start Trial	Start Trial	Y			Start 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 rotigotine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-002	May 9, 2007	Start Trial	Start Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012	Start Trial	Start Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-006	Apr 2, 2012	Start Trial	Start Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007	Start Trial	Start Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-005	Apr 2, 2012	Start Trial	Start Trial
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-001	May 9, 2007	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for rotigotine

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Country	Patent Number	Estimated Expiration
Czech Republic	297889	Start Trial
European Patent Office	3257504	Start Trial
Russian Federation	2266735	Start Trial
Brazil	9909313	Start Trial
European Patent Office	1386605	Start Trial
Japan	2013241459	Start Trial
Japan	6006184	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for rotigotine

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1033978	C300236	Netherlands	Start Trial	PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001-013 20060215
1033978	CA 2006 00020	Denmark	Start Trial	PRODUCT NAME: ROTIGOTINE
1033978	06C0025	France	Start Trial	PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 20060215
1033978	SZ 24/2006	Austria	Start Trial	PRODUCT NAME: ROTIGOTINE
1033978	SPC/GB06/023	United Kingdom	Start Trial	SPC/GB06/023: 20070702, EXPIRES: 20210214
1033978	SPC026/2006	Ireland	Start Trial	SPC026/2006:, EXPIRES: 20210214
1033978	24/2006	Austria	Start Trial	PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 - EU/1/05/331/013 20060215
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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 verifification 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.

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