NEOPROFEN Drug Patent 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 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 30th, 2016.
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 |
![NEOPROFEN drug patent expirations Drug patent expirations by year for NEOPROFEN](/p/graph/s/t/NEOPROFEN-patent-expirations.png)
![Drug Prices for NEOPROFEN](/p/graph/drug-price/NEOPROFEN.png)
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 |
Pharmacology for NEOPROFEN
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for NEOPROFEN
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
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
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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
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.) | ⤷ Try a Trial |
Mexico | PA02003033 | METODO PARA PREVENIR RETINOPATIA PREMATURA EN UN NEONATO. (METHOD OF PREVENTING RETINOPATHY OF PREMATURITY IN A NEONATE.) | ⤷ Try a Trial |
Japan | 2002193799 | PHARMACEUTICAL COMPOSITION, METHOD OF PREPARING THE SAME AND METHOD OF TREATMENT | ⤷ Try a Trial |
Japan | 2002326929 | METHOD FOR PREVENTING RETINOPATHY OF PREMATURITY IN HEWBORN INFANT | ⤷ Try a Trial |
Austria | 293444 | ⤷ Try a Trial | |
European Patent Office | 1249234 | Méthode de prévention de la rétinopathie chez les nouveaux-nés prématurés (Method of preventing retinopathy of prematurity in a neonate) | ⤷ Try a Trial |
Germany | 60110185 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEOPROFEN
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 |