NEOPROFEN Drug Patent Profile

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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 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.

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.

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Summary for NEOPROFEN

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	4
Patent Applications:	207
Formulation / Manufacturing:	see details
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

Drug patent expirations by year for NEOPROFEN

Recent Clinical Trials for NEOPROFEN

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

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

Patents protecting NEOPROFEN

Ibuprofen compositions and methods of making same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y	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 NEOPROFEN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	⤷ Sign Up	⤷ Sign Up
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for NEOPROFEN

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

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Country	Patent Number	Title	Estimated Expiration
Canada	2361160		⤷ Sign Up
Austria	318136		⤷ Sign Up
Mexico	PA02003033	METODO PARA PREVENIR RETINOPATIA PREMATURA EN UN NEONATO. (METHOD OF PREVENTING RETINOPATHY OF PREMATURITY IN A NEONATE.)	⤷ Sign Up
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)	⤷ Sign Up
Austria	293444		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NEOPROFEN

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