Osmoprep is a drug owned by Salix Pharmaceuticals Inc. It is protected by 2 US drug patents filed in 2013. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 22, 2028. Details of Osmoprep'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. | |||
| US7687075 | Colonic purgative composition with soluble binding agent |
Jun, 2028
(3 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). | |||
| US5616346 | Non-aqueous colonic purgative formulations |
May, 2013
(11 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 Osmoprep's patents.
Latest Legal Activities on Osmoprep's Patents
Given below is the list of recent legal activities going on the following patents of Osmoprep.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Aug, 2021 | US7687075 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Aug, 2017 | US7687075 |
| Correspondence Address Change Critical | 25 Oct, 2010 | US7687075 |
| Patent Issue Date Used in PTA Calculation Critical | 30 Mar, 2010 | US7687075 |
| Recordation of Patent Grant Mailed Critical | 30 Mar, 2010 | US7687075 |
| Issue Notification Mailed Critical | 10 Mar, 2010 | US7687075 |
| Dispatch to FDC | 03 Mar, 2010 | US7687075 |
| Application Is Considered Ready for Issue Critical | 25 Feb, 2010 | US7687075 |
| Printer Rush- No mailing | 23 Feb, 2010 | US7687075 |
| Miscellaneous Communication to Applicant - No Action Count | 23 Feb, 2010 | US7687075 |
US patents provide insights into the exclusivity only within the United States, but Osmoprep 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 Osmoprep's family patents as well as insights into ongoing legal events on those patents.
Osmoprep's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Osmoprep's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 22, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Osmoprep Generic API suppliers:
Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate is the generic name for the brand Osmoprep. 1 company has already filed for the generic of Osmoprep. Check out the entire list of companies who have already received approval for Osmoprep's generic
How can I launch a generic of Osmoprep before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Osmoprep's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Osmoprep'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 Osmoprep -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.102 g and 0.398 g | 09 Apr, 2008 | 1 | 30 Dec, 2011 | 18 May, 2013 | Eligible |
Alternative Brands for Osmoprep
Osmoprep which is used for bowel cleansing in preparation for colonoscopy in adults., has several other brand drugs using the same active ingredient (Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Salix Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate, Osmoprep's active ingredient. Check the complete list of approved generic manufacturers for Osmoprep
About Osmoprep
Osmoprep is a drug owned by Salix Pharmaceuticals Inc. It is used for bowel cleansing in preparation for colonoscopy in adults. Osmoprep uses Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate as an active ingredient. Osmoprep was launched by Salix Pharms in 2006.
Approval Date:
Osmoprep was approved by FDA for market use on 16 March, 2006.
Active Ingredient:
Osmoprep uses Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate as the active ingredient. Check out other Drugs and Companies using Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate ingredient
Treatment:
Osmoprep is used for bowel cleansing in preparation for colonoscopy in adults.
Dosage:
Osmoprep is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.398GM;1.102GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |