NEOPROFEN Drug Patent Profile

When do Neoprofen patents expire, and when can generic versions of Neoprofen launch?

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Neoprofen

A generic version of NEOPROFEN was approved as ibuprofen lysine by XGEN PHARMS on March 30^th, 2016.

Summary for NEOPROFEN

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	278
Drug Prices:	Drug price information for NEOPROFEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEOPROFEN
What excipients (inactive ingredients) are in NEOPROFEN?	NEOPROFEN excipients list
DailyMed Link:	NEOPROFEN at DailyMed

See drug prices for NEOPROFEN

Recent Clinical Trials for NEOPROFEN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
State University of New York - Downstate Medical Center	Phase 2
Food and Drug Administration (FDA)	Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2

See all NEOPROFEN clinical trials

Pharmacology for NEOPROFEN

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for NEOPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEOPROFEN	Injection	ibuprofen lysine	10 mg/mL, 2 mL vials	021903	1	2010-10-01

US Patents and Regulatory Information for NEOPROFEN

NEOPROFEN is protected by one US patents.

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	8,415,337		Y	Y

Expired US Patents for NEOPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	6,342,530
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	6,344,479

International Patents for NEOPROFEN

See the table below for patents covering NEOPROFEN around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	293444
Canada	2361160
Germany	60110185
European Patent Office	1205181	Composition et procédé pour l'administration parentérale de D,L- ou L-lysinate d'ibuprofène (Composition and method for parenteral administration of ibuprofen D, L-or L-Lysine salt)
Japan	2002193799	PHARMACEUTICAL COMPOSITION, METHOD OF PREPARING THE SAME AND METHOD OF TREATMENT
Mexico	PA01011629	COMPOSICION Y METODO PARA LA ADMINISTRACION PARENTERAL DE SAL DE D,L O L-LISINA DE IBUPROPENO. (COMPOSITION AND METHOD FOR PARENTERAL ADMINISTRATION OF IBUPROFEN D,L- OR L-LYSINE SALT.)

Supplementary Protection Certificates for NEOPROFEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781277	PA2024501	Lithuania		PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726