NEUPRO Drug Patent Profile
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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 six patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-five patent family members in twenty-nine 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 ten 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: | 85 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 74 |
Clinical Trials: | 38 |
Patent Applications: | 1,921 |
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 |
---|---|
I.R.C.C.S. Fondazione Santa Lucia | Phase 2 |
Alzheimer's Drug Discovery Foundation | Phase 2 |
UCB Biopharma S.P.R.L. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for NEUPRO
Paragraph IV (Patent) Challenges for NEUPRO
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 NEUPRO
NEUPRO is protected by seven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEUPRO is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting NEUPRO
Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Transdermal delivery system for the administration of rotigotine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SIGNS AND SYMPTOMS OF PARKINSON'S DISEASE BY APPLICATION OF CLAIMED TRANSDERMAL SYSTEM
Transdermal delivery system for the administration of rotigotine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY SYSTEM
Transdermal delivery system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Transdermal delivery system for the administration of rotigotine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR THE TREATMENT OF A PATIENT SUFFERING FROM A DISEASE TREATABLE WITH ROTIGOTINE, COMPRISING APPLYING THE CLAIMED TRANSDERMAL DELIVERY SYSTEM (TDS) TO THE SKIN OF THE PATIENT
Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Patent Number: See Plans and Pricing
Patent Expiration: 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-006 | 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 | 021829-003 | 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 NEUPRO
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-006 | Apr 2, 2012 | 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 | 021829-004 | Apr 2, 2012 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NEUPRO
When does loss-of-exclusivity occur for NEUPRO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 03266252
Estimated Expiration: See Plans and Pricing
Austria
Patent: 3380
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 13092
Estimated Expiration: See Plans and Pricing
Canada
Patent: 90573
Estimated Expiration: See Plans and Pricing
China
Patent: 71365
Estimated Expiration: See Plans and Pricing
Patent: 0558350
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 24971
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 86604
Estimated Expiration: See Plans and Pricing
Patent: 24971
Estimated Expiration: See Plans and Pricing
Germany
Patent: 309329
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 83458
Estimated Expiration: See Plans and Pricing
Israel
Patent: 5917
Estimated Expiration: See Plans and Pricing
Japan
Patent: 37915
Estimated Expiration: See Plans and Pricing
Patent: 05535686
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 05000349
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 7476
Estimated Expiration: See Plans and Pricing
Norway
Patent: 4187
Estimated Expiration: See Plans and Pricing
Patent: 050770
Estimated Expiration: See Plans and Pricing
Poland
Patent: 6999
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 24971
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 24971
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0500255
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1016914
Estimated Expiration: See Plans and Pricing
Patent: 050025638
Estimated Expiration: See Plans and Pricing
Spain
Patent: 73042
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering NEUPRO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4837915 | See Plans and Pricing | |
Poland | 198323 | See Plans and Pricing | |
Hungary | 0203318 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEUPRO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1033978 | SZ 24/2006 | Austria | See Plans and Pricing | PRODUCT NAME: ROTIGOTINE |
1033978 | C300236 | Netherlands | See Plans and Pricing | PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001-013 20060215 |
1033978 | SPC026/2006 | Ireland | See Plans and Pricing | SPC026/2006:, EXPIRES: 20210214 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |