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 eight patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and fifty-nine patent family members in thirty-eight 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.
US ANDA Litigation and 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 nine 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: | 159 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 65 |
| Clinical Trials: | 38 |
| Patent Applications: | 127 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NEUPRO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NEUPRO |
| DailyMed Link: | NEUPRO at DailyMed |
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 |
| National Institute on Aging (NIA) | 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 | 021829-003 | 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 | |||
| 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 | 021829-003 | 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 NEUPRO
| 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 | Start Trial | Start Trial |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-002 | May 9, 2007 | Start Trial | Start Trial |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-003 | May 9, 2007 | Start Trial | Start Trial |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-001 | May 9, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NEUPRO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 025584 | Start Trial |
| China | 1671375 | Start Trial |
| Spain | 2256780 | Start Trial |
| Poland | 355606 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NEUPRO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1033978 | C01033978/01 | Switzerland | Start Trial | TEILUEBERTRAGUNG |
| 1033978 | CA 2006 00020 | Denmark | Start Trial | PRODUCT NAME: ROTIGOTINE |
| 1033978 | 06C0025 | France | Start Trial | PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 20060215 |
| 1033978 | SPC026/2006 | Ireland | Start Trial | SPC026/2006:, EXPIRES: 20210214 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
