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Last Updated: September 28, 2021

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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 seven 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 twenty-seven patent family members in thirty-seven countries.

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

Recent Clinical Trials for rotigotine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alzheimer's Drug Discovery FoundationPhase 2
SandozPhase 1
UCB Biopharma S.P.R.L.Phase 3

See all rotigotine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for rotigotine
Paragraph IV (Patent) Challenges for ROTIGOTINE
Tradename Dosage Ingredient NDA Submissiondate
NEUPRO FILM, EXTENDED RELEASE;TRANSDERMAL rotigotine 021829 2013-11-26

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

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

Supplementary Protection Certificates for rotigotine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1033978 C300236 Netherlands ⤷  Free Forever Trial PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001-013 20060215
1033978 91269 Luxembourg ⤷  Free Forever Trial 91269, EXPIRES: 20210215
1033978 06C0025 France ⤷  Free Forever Trial PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 20060215
1033978 24/2006 Austria ⤷  Free Forever Trial PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 - EU/1/05/331/013 20060215
1033978 SPC026/2006 Ireland ⤷  Free Forever Trial SPC026/2006:, EXPIRES: 20210214
1033978 C01033978/01 Switzerland ⤷  Free Forever Trial TEILUEBERTRAGUNG
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Mallinckrodt
AstraZeneca
Dow
Colorcon

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