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Last Updated: January 21, 2020

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NEUPRO Drug Profile

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Which patents cover Neupro, and when can generic versions of Neupro launch?

Neupro is a drug marketed by Ucb Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-nine patent family members in thirty-eight 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.

US ANDA Litigation and Generic Entry Outlook for Neupro

  Start Trial

Neupro was eligible for patent challenges on May 9th, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 1st, 2032. This may change due to patent challenges or generic licensing.

There have been seven 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.

Drug patent expirations by year for NEUPRO
Drug Prices for NEUPRO

See drug prices for NEUPRO

Generic Entry Opportunity Date for NEUPRO
Generic Entry Date for NEUPRO*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
UCB Biopharma S.P.R.L.Phase 3
UCB Biopharma S.P.R.L.Phase 4
National Institute on Aging (NIA)Phase 4

See all NEUPRO clinical trials

Recent Litigation for NEUPRO

Identify potential future generic entrants

District Court Litigation
Case NameDate
UCB, Inc. v. Mylan Technologies, Inc.2017-03-24
UCB Inc. v. Zydus Worldwide DMCC2016-11-03
UCB Inc. v. Watson Laboratories Inc. (NV)2014-08-21

See all NEUPRO litigation

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)-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 (TN)
PubChem16423
RL06136
Rotigotine
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
Paragraph IV (Patent) Challenges for NEUPRO
Tradename Dosage Ingredient NDA Submissiondate
NEUPRO FILM, EXTENDED RELEASE;TRANSDERMAL rotigotine 021829 2013-11-26

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 021829-003 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 021829-003 May 9, 2007 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 NEUPRO

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

Supplementary Protection Certificates for NEUPRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1033978 SZ 24/2006 Austria   Start Trial PRODUCT NAME: ROTIGOTINE
1033978 CA 2006 00020 Denmark   Start Trial PRODUCT NAME: ROTIGOTINE
1033978 C300236 Netherlands   Start Trial PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001-013 20060215
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Moodys
Colorcon
Mallinckrodt
McKesson

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.