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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 eight 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 fifty-nine patent family members in thirty-eight countries.
There are seven drug master file entries for rotigotine. One supplier is listed for this compound.
Summary for rotigotine
| International Patents: | 159 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 65 |
| Clinical Trials: | 77 |
| Patent Applications: | 172 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for rotigotine |
| DailyMed Link: | rotigotine at DailyMed |
Recent Clinical Trials for rotigotine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sandoz | Phase 1 |
| UCB Biopharma S.P.R.L. | Phase 3 |
| UCB Biopharma S.P.R.L. | Phase 4 |
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 | 021829-006 | Apr 2, 2012 | 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 | 021829-002 | 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 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 | Start Trial | Start Trial |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-006 | Apr 2, 2012 | Start Trial | Start Trial |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-004 | Apr 2, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for rotigotine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2326630 | Start Trial |
| Spain | 2256780 | Start Trial |
| Portugal | 2515887 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for rotigotine
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1033978 | 91269 | Luxembourg | Start Trial | 91269, EXPIRES: 20210215 |
| 1033978 | C300236 | Netherlands | Start Trial | PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001-013 20060215 |
| 1033978 | SPC/GB06/023 | United Kingdom | Start Trial | SPC/GB06/023: 20070702, EXPIRES: 20210214 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
