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NEOPROFEN Drug 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 are three patents protecting this drug and one Paragraph IV challenge.
This drug has twelve patent family members in six countries.
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.
US ANDA Litigation and Generic Entry Outlook for Neoprofen
A generic version of NEOPROFEN was approved as ibuprofen lysine by X-GEN PHARMS INC on January 20th, 2020.
Summary for NEOPROFEN
| International Patents: | 12 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 36 |
| Clinical Trials: | 1 |
| Patent Applications: | 168 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NEOPROFEN |
| DailyMed Link: | NEOPROFEN at DailyMed |
Recent Clinical Trials for NEOPROFEN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| OSF Healthcare System | Phase 4 |
Pharmacology for NEOPROFEN
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
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
| 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 | Start Trial | Start Trial | Y | Start Trial | ||
| Recordati Rare | NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903-001 | Apr 13, 2006 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Recordati Rare | NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903-001 | Apr 13, 2006 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Y | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for NEOPROFEN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | PA01011629 | Start Trial |
| Germany | 60110185 | Start Trial |
| Canada | 2377453 | Start Trial |
| European Patent Office | 1249234 | Start Trial |
| Canada | 2361160 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
