DrugPatentWatch Database Preview
NEUPRO Drug Profile
» See Plans and Pricing
Which patents cover Neupro, and what generic alternatives are available?
Neupro is a drug marketed by Ucb Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twenty-seven patent family members in thirty-seven countries.
The generic ingredient in NEUPRO is rotigotine. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rotigotine profile page.
DrugPatentWatch® Generic Entry Outlook for Neupro
Neupro was eligible for patent challenges on May 9, 2011.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 1, 2032. This may change due to patent challenges or generic licensing.
There have been twelve patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for NEUPRO
| International Patents: | 127 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 38 |
| Patent Applications: | 1,655 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NEUPRO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NEUPRO |
| What excipients (inactive ingredients) are in NEUPRO? | NEUPRO excipients list |
| DailyMed Link: | NEUPRO at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for NEUPRO
Generic Entry Date for NEUPRO*:
Constraining patent/regulatory exclusivity:
NDA:
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 NEUPRO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| UCB Biopharma S.P.R.L. | Phase 3 |
| UCB Biopharma S.P.R.L. | Phase 4 |
| Johns Hopkins University | Phase 4 |
Paragraph IV (Patent) Challenges for NEUPRO
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NEUPRO | FILM, EXTENDED RELEASE;TRANSDERMAL | rotigotine | 021829 | 2013-11-26 |
US Patents and Regulatory Information for NEUPRO
| 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 | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-002 | May 9, 2007 | RX | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-006 | Apr 2, 2012 | RX | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-002 | May 9, 2007 | RX | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-003 | May 9, 2007 | RX | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-002 | May 9, 2007 | RX | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-004 | Apr 2, 2012 | RX | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| >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 NEUPRO
| 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 | Get Started for $10 | Get Started for $10 |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-002 | May 9, 2007 | Get Started for $10 | Get Started for $10 |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-004 | Apr 2, 2012 | Get Started for $10 | Get Started for $10 |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-001 | May 9, 2007 | Get Started for $10 | Get Started for $10 |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-004 | Apr 2, 2012 | Get Started for $10 | Get Started for $10 |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-003 | May 9, 2007 | Get Started for $10 | Get Started for $10 |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-005 | Apr 2, 2012 | Get Started for $10 | Get Started for $10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NEUPRO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 0139753 | Get Started for $10 |
| Mexico | 2012007326 | Get Started for $10 |
| Australia | 2934199 | Get Started for $10 |
| World Intellectual Property Organization (WIPO) | 2004012719 | Get Started for $10 |
| Japan | 3984785 | Get Started for $10 |
| Japan | 6006184 | Get Started for $10 |
| Brazil | 112012017737 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NEUPRO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1033978 | SPC026/2006 | Ireland | Get Started for $10 | SPC026/2006:, EXPIRES: 20210214 |
| 1033978 | C300236 | Netherlands | Get Started for $10 | PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001-013 20060215 |
| 1033978 | 91269 | Luxembourg | Get Started for $10 | 91269, EXPIRES: 20210215 |
| 1033978 | 24/2006 | Austria | Get Started for $10 | PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 - EU/1/05/331/013 20060215 |
| 1033978 | 06C0025 | France | Get Started for $10 | PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 20060215 |
| 1033978 | CA 2006 00020 | Denmark | Get Started for $10 | PRODUCT NAME: ROTIGOTINE |
| 1033978 | SPC/GB06/023 | United Kingdom | Get Started for $10 | SPC/GB06/023: 20070702, EXPIRES: 20210214 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
