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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: | 45 |
| Clinical Trials: | 4 |
| Patent Applications: | 193 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
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 | NDA | Submissiondate |
|---|---|---|---|---|
| NEOPROFEN | INJECTABLE;INTRAVENOUS | ibuprofen lysine | 021903 | 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 it Free
Patent Expiration: ⤷ Try it Free
| 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 it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | |
| >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 it Free | ⤷ Try it Free |
| Recordati Rare | NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903-001 | Apr 13, 2006 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NEOPROFEN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 60209269 | ⤷ Try it Free |
| Canada | 2361160 | ⤷ Try it Free |
| European Patent Office | 1205181 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
