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NEOPROFEN Drug Profile

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Which patents cover Neoprofen, and when can generic versions of Neoprofen launch?

Neoprofen is a drug marketed by Recordati Rare and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twelve patent family members in six countries.

The generic ingredient in NEOPROFEN is ibuprofen lysine. There are sixty-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ibuprofen lysine profile page.

Summary for NEOPROFEN

International Patents:	12
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	25
Clinical Trials:	1
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	NEOPROFEN at DailyMed

Pharmacology for NEOPROFEN

Ingredient-type	Nonsteroidal Anti-inflammatory Compounds
Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for NEOPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	AP	RX	Yes	Yes			Y
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	AP	RX	Yes	Yes			Y	Y
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	AP	RX	Yes	Yes			Y	Y	Y

Paragraph IV (Patent) Challenges for NEOPROFEN

Drugname	Dosage	Strength	RLD	Submissiondate
	Injection	10 mg/mL, 2 mL vial		2010-10-01

International Patents for NEOPROFEN

Country	Document Number	Estimated Expiration
Canada	2377453
Japan	2002326929
European Patent Office	1249234
European Patent Office	1205181