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 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.
Summary for rotigotine
International Patents: | 85 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 84 |
Clinical Trials: | 81 |
Patent Applications: | 2,960 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for rotigotine |
What excipients (inactive ingredients) are in rotigotine? | rotigotine excipients list |
DailyMed Link: | rotigotine at DailyMed |
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
Sponsor | Phase |
---|---|
National Institute on Drug Abuse (NIDA) | Phase 2 |
Virginia Commonwealth University | Phase 2 |
Hoffmann-La Roche | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for rotigotine
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-001 | May 9, 2007 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-005 | Apr 2, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-001 | May 9, 2007 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-004 | Apr 2, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 | 021829-005 | Apr 2, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-005 | Apr 2, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-004 | Apr 2, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-005 | Apr 2, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-002 | May 9, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Israel | 165917 | TRANSDERMAL DELIVERY SYSTEM | ⤷ Sign Up |
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) | ⤷ Sign Up |
Mexico | PA05000349 | SISTEMA MEJORADO DE ENTREGA TRANSDERMAL. (IMPROVED TRANSDERMAL DELIVERY SYSTEM.) | ⤷ Sign Up |
Portugal | 2515887 | ⤷ Sign Up | |
Brazil | 0313092 | Sistema de liberação transdérmica aperfeiçoado | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for rotigotine
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1033978 | 06C0025 | France | ⤷ Sign Up | PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 20060215 |
1033978 | SZ 24/2006 | Austria | ⤷ Sign Up | PRODUCT NAME: ROTIGOTINE |
1033978 | CA 2006 00020 | Denmark | ⤷ Sign Up | PRODUCT NAME: ROTIGOTINE |
1033978 | 24/2006 | Austria | ⤷ Sign Up | PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 - EU/1/05/331/013 20060215 |
1033978 | C300236 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001-013 20060215 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |