NEOPROFEN Drug Patent Profile

✉ Email this page to a colleague

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 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.

Try a Trial

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

See all NEOPROFEN clinical trials

Pharmacology for NEOPROFEN

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

Anatomical Therapeutic Chemical (ATC) Classes for NEOPROFEN

B05XB	Amino acids
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try a Trial
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	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>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

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	⤷ Try a Trial	⤷ Try a Trial
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	⤷ Try a Trial	⤷ Try a Trial
>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.

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Austria	318136		⤷ Try a Trial
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)	⤷ Try a Trial
Canada	2377453		⤷ Try a Trial
Austria	293444		⤷ Try a Trial
Japan	2002326929	METHOD FOR PREVENTING RETINOPATHY OF PREMATURITY IN HEWBORN INFANT	⤷ Try a Trial
Germany	60110185		⤷ Try a Trial
Japan	2002193799	PHARMACEUTICAL COMPOSITION, METHOD OF PREPARING THE SAME AND METHOD OF TREATMENT	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NEOPROFEN

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781277	PA2024501	Lithuania	⤷ Try a Trial	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