NEUPRO Drug Patent Profile
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When do Neupro patents expire, and when can generic versions of Neupro launch?
Neupro is a drug marketed by Ucb Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-nine patent family members in thirty 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
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Summary for NEUPRO
| International Patents: | 89 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 84 |
| Clinical Trials: | 39 |
| Patent Applications: | 1,283 |
| 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 Loss of Exclusivity (LOE) Date for NEUPRO
*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 |
|---|---|
| National Institute on Drug Abuse (NIDA) | Phase 2 |
| Virginia Commonwealth University | Phase 2 |
| I.R.C.C.S. Fondazione Santa Lucia | Phase 2 |
Pharmacology for NEUPRO
| Drug Class | Nonergot Dopamine Agonist |
| Mechanism of Action | Dopamine Agonists |
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 six US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEUPRO is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Transdermal delivery system for the administration of rotigotine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY SYSTEM
Transdermal delivery system
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| 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 | 021829-003 | May 9, 2007 | RX | Yes | No | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-001 | May 9, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-002 | May 9, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Ucb Inc | NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829-005 | Apr 2, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for NEUPRO
| 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 NEUPRO
See the table below for patents covering NEUPRO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | 226733 | TRANSDERMAL THERAPEUTIC SYSTEM WHICH CONTAINS A D2 AGONIST AND WHICH IS PROVIDED FOR TREATING PARKINSONISM, AND A METHOD FOR THE PRODUCTION THEREOF | ⤷ Sign Up |
| Hong Kong | 1031196 | ⤷ Sign Up | |
| Israel | 165917 | TRANSDERMAL DELIVERY SYSTEM | ⤷ Sign Up |
| Poland | 376999 | Ulepszony system podawania przezskórnego (IMPROVED TRANSDERMAL DELIVERY SYSTEM) | ⤷ Sign Up |
| >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 | ⤷ Sign Up | PRODUCT NAME: ROTIGOTINE |
| 1033978 | SPC/GB06/023 | United Kingdom | ⤷ Sign Up | SPC/GB06/023: 20070702, EXPIRES: 20210214 |
| 1033978 | CA 2006 00020 | Denmark | ⤷ Sign Up | PRODUCT NAME: ROTIGOTINE |
| 1033978 | 06C0025 | France | ⤷ Sign Up | PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 20060215 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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