Details for New Drug Application (NDA): 021829
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NDA 021829 describes NEUPRO, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NEUPRO profile page.
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.
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.
Summary for 021829
| Tradename: | NEUPRO |
| Applicant: | Ucb Inc |
| Ingredient: | rotigotine |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021829
*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.
Pharmacology for NDA: 021829
| Mechanism of Action | Dopamine Agonists |
Suppliers and Packaging for NDA: 021829
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829 | NDA | UCB, Inc. | 50474-801 | 50474-801-03 | 30 POUCH in 1 CARTON (50474-801-03) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH |
| NEUPRO | rotigotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021829 | NDA | UCB, Inc. | 50474-801 | 50474-801-17 | 7 POUCH in 1 CARTON (50474-801-17) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 2MG/24HR | ||||
| Approval Date: | May 9, 2007 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 22, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 22, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 1, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY SYSTEM | ||||||||
Expired US Patents for NDA 021829
| 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 | ⤷ 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 |
| 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 | 021829-004 | 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 | 021829-004 | Apr 2, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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