Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Boehringer Ingelheim
Moodys
AstraZeneca
Baxter

Last Updated: January 30, 2023

Rotigotine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 six 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.

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

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 021829-005 Apr 2, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-002 May 9, 2007 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-001 May 9, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-003 May 9, 2007 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-003 May 9, 2007 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-002 May 9, 2007 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 021829-001 May 9, 2007 See Plans and Pricing See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-004 Apr 2, 2012 See Plans and Pricing See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-005 Apr 2, 2012 See Plans and Pricing See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-003 May 9, 2007 See Plans and Pricing See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-001 May 9, 2007 See Plans and Pricing See Plans and Pricing
Ucb Inc NEUPRO rotigotine FILM, EXTENDED RELEASE;TRANSDERMAL 021829-001 May 9, 2007 See Plans and Pricing See Plans and Pricing
>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
China 1671365 Improved transdermal delivery system See Plans and Pricing
Hong Kong 1200335 用於使非結晶形式的羅替戈汀的固體分散體穩定化的聚乙烯吡咯烷酮 (POLYVINYLPYRROLIDONE FOR THE STABILIZATION OF A SOLID DISPERSION OF THE NON-CRYSTALLINE FORM OF ROTIGOTINE) See Plans and Pricing
Canada 2491366 SYSTEME D'ADMINISTRATION TRANSDERMIQUE AMELIORE CONCU POUR ADMINISTRER LA ROTIGOTINE (IMPROVED TRANSDERMAL DELIVERY SYSTEM FOR THE ADMINISTRATION OF ROTIGOTINE) See Plans and Pricing
Japan 5564469 See Plans and Pricing
Japan 4837915 See Plans and Pricing
South Korea 20120107971 POLYVINYLPYRROLIDONE FOR THE STABILIZATION OF A SOLID DISPERSION OF THE NON-CRYSTALLINE FORM OF ROTIGOTINE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for rotigotine

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

Johnson and Johnson
McKinsey
Express Scripts
Boehringer Ingelheim
Baxter
Merck

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 verification 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.