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.

Summary for 021829

Tradename:	NEUPRO
Applicant:	Ucb Inc
Ingredient:	rotigotine
Patents:	5

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 021829

Generic Entry Date for 021829^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 6,884,434 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.

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:	10,130,589	Patent Expiration:	Dec 22, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,350,174	Patent Expiration:	Dec 22, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,246,979	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007	7,413,747	⤷ Subscribe
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-005	Apr 2, 2012	6,884,434	⤷ Subscribe
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-001	May 9, 2007	6,699,498	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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