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Last Updated: March 29, 2024

Rotigotine - Generic Drug Details


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What are the generic drug 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 five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rotigotine has eighty-five patent family members in twenty-nine countries.

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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for rotigotine
Generic Entry Date for rotigotine*:
Constraining patent/regulatory exclusivity:
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 rotigotine

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

SponsorPhase
National Institute on Drug Abuse (NIDA)Phase 2
Virginia Commonwealth UniversityPhase 2
Alzheimer's Drug Discovery FoundationPhase 2

See all rotigotine clinical trials

Paragraph IV (Patent) Challenges for ROTIGOTINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NEUPRO Extended-release Transdermal Film rotigotine 1 mg/24 hr 2 mg/24 hr 3 mg/24 hr 4 mg/24 hr 6 mg/24 hr 8 mg/24 hr 021829 1 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 021829-006 Apr 2, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-002 May 9, 2007 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-003 May 9, 2007 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-001 May 9, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-001 May 9, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-002 May 9, 2007 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 021829-004 Apr 2, 2012 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-001 May 9, 2007 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-003 May 9, 2007 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-001 May 9, 2007 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-002 May 9, 2007 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-002 May 9, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for rotigotine

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
UCB Pharma S.A.   Leganto rotigotine EMEA/H/C/002380
Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.Leganto is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations).
Withdrawn no no no 2011-06-16
UCB Pharma S.A. Neupro rotigotine EMEA/H/C/000626
Parkinson's disease: Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations).Restless-legs syndrome: Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.
Authorised no no no 2006-02-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for rotigotine

Country Patent Number Title Estimated Expiration
European Patent Office 2515887 POLYVINYLPYRROLIDONE DESTINÉE À LA STABILISATION D'UNE DISPERSION SOLIDE DE LA FORME NON CRISTALLINE DE LA ROTIGOTINE (POLYVINYLPYRROLIDONE FOR THE STABILIZATION OF A SOLID DISPERSION OF THE NON-CRYSTALLINE FORM OF ROTIGOTINE) ⤷  Try a Trial
Serbia 57457 POLIVINILPIROLIDON ZA STABILIZACIJU ČVRSTE DISPERZIJE NEKRISTALNOG OBLIKA ROTIGOTINA (POLYVINYLPYRROLIDONE FOR THE STABILIZATION OF A SOLID DISPERSION OF THE NON-CRYSTALLINE FORM OF ROTIGOTINE) ⤷  Try a Trial
Croatia P20181173 ⤷  Try a Trial
Norway 20050770 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2004012730 ⤷  Try a Trial
South Korea 20170023772 비결정질형 로티고틴의 고체 분산체의 안정화를 위한 폴리비닐피롤리돈 (POLYVINYLPYRROLIDONE FOR THE STABILIZATION OF A SOLID DISPERSION OF THE NON-CRYSTALLINE FORM OF ROTIGOTINE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for rotigotine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1033978 CA 2006 00020 Denmark ⤷  Try a Trial PRODUCT NAME: ROTIGOTINE
1033978 24/2006 Austria ⤷  Try a Trial PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 - EU/1/05/331/013 20060215
1033978 06C0025 France ⤷  Try a Trial PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 20060215
1033978 SZ 24/2006 Austria ⤷  Try a Trial PRODUCT NAME: ROTIGOTINE
1033978 C300236 Netherlands ⤷  Try a 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

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