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 30th, 2016.
Summary for NEOPROFEN
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 55 |
| Clinical Trials: | 4 |
| Patent Applications: | 193 |
| 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 |
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 |
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | |
| >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 | See Plans and Pricing | See Plans and Pricing |
| Recordati Rare | NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903-001 | Apr 13, 2006 | See Plans and Pricing | See Plans and Pricing |
| >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 |
|---|---|---|---|
| Japan | 2002326929 | METHOD FOR PREVENTING RETINOPATHY OF PREMATURITY IN HEWBORN INFANT | See Plans and Pricing |
| Austria | 293444 | See Plans and Pricing | |
| Germany | 60209269 | See Plans and Pricing | |
| Japan | 2002193799 | PHARMACEUTICAL COMPOSITION, METHOD OF PREPARING THE SAME AND METHOD OF TREATMENT | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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