Neoprofen is a drug owned by Recordati Rare Diseases Inc. It is protected by 3 US drug patents filed in 2013. Out of these, 1 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 02, 2032. Details of Neoprofen's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8415337 | Ibuprofen compositions and methods of making same |
Mar, 2032
(7 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6344479 | Method of preventing retinopathy of prematurity in a neonate |
Mar, 2021
(3 years ago) |
Expired
|
| US6342530 | Composition and method for parenteral administration of ibuprofen d,l- or l-lysine salt |
Nov, 2020
(4 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Neoprofen's patents.
Latest Legal Activities on Neoprofen's Patents
Given below is the list of recent legal activities going on the following patents of Neoprofen.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Sep, 2020 | US8415337 |
| Change in Power of Attorney (May Include Associate POA) Critical | 30 Apr, 2013 | US8415337 |
| Email Notification Critical | 30 Apr, 2013 | US8415337 |
| Correspondence Address Change Critical | 18 Apr, 2013 | US8415337 |
| Recordation of Patent Grant Mailed Critical | 09 Apr, 2013 | US8415337 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Apr, 2013 | US8415337 |
| Email Notification Critical | 22 Mar, 2013 | US8415337 |
| Issue Notification Mailed Critical | 20 Mar, 2013 | US8415337 |
| Dispatch to FDC | 14 Mar, 2013 | US8415337 |
| Workflow - Drawings Finished | 13 Mar, 2013 | US8415337 |
FDA has granted several exclusivities to Neoprofen. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Neoprofen, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Neoprofen.
Exclusivity Information
Neoprofen holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Neoprofen's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Apr 13, 2013 |
US patents provide insights into the exclusivity only within the United States, but Neoprofen is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Neoprofen's family patents as well as insights into ongoing legal events on those patents.
Neoprofen's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Neoprofen's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 02, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Neoprofen Generic API suppliers:
Ibuprofen Lysine is the generic name for the brand Neoprofen. 1 company has already filed for the generic of Neoprofen. Check out the entire list of companies who have already received approval for Neoprofen's generic
How can I launch a generic of Neoprofen before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Neoprofen's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Neoprofen's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Neoprofen -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/mL, 2 mL vials | 01 Oct, 2010 | 1 | 30 Mar, 2016 | 20 Mar, 2021 | Extinguished Deferred |
About Neoprofen
Neoprofen is a drug owned by Recordati Rare Diseases Inc. It is used for closing a clinically significant patent ductus arteriosus in premature infants weighing between 500 and 1500g. Neoprofen uses Ibuprofen Lysine as an active ingredient. Neoprofen was launched by Recordati Rare in 2006.
Approval Date:
Neoprofen was approved by FDA for market use on 13 April, 2006.
Active Ingredient:
Neoprofen uses Ibuprofen Lysine as the active ingredient. Check out other Drugs and Companies using Ibuprofen Lysine ingredient
Treatment:
Neoprofen is used for closing a clinically significant patent ductus arteriosus in premature infants weighing between 500 and 1500g.
Dosage:
Neoprofen is available in injectable form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE/2ML (EQ 10MG BASE/ML) | INJECTABLE | Prescription | INTRAVENOUS |