Aciphex Sprinkle is a drug owned by Aytu Bioscience Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 26, 2016. Details of Aciphex Sprinkle's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US5045552 (Pediatric) | Pyridine derivatives having anti-ulcerative activity |
Nov, 2013
(11 years ago) |
Expired
|
| US5045552 | Pyridine derivatives having anti-ulcerative activity |
May, 2013
(11 years ago) |
Expired
|
FDA has granted several exclusivities to Aciphex Sprinkle. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aciphex Sprinkle, 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 Aciphex Sprinkle.
Exclusivity Information
Aciphex Sprinkle holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Aciphex Sprinkle's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Mar 26, 2016 |
| Pediatric Exclusivity(PED) | Sep 26, 2016 |
US patents provide insights into the exclusivity only within the United States, but Aciphex Sprinkle 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 Aciphex Sprinkle's family patents as well as insights into ongoing legal events on those patents.
Aciphex Sprinkle's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aciphex Sprinkle's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 26, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aciphex Sprinkle Generic API suppliers:
Rabeprazole Sodium is the generic name for the brand Aciphex Sprinkle. 10 different companies have already filed for the generic of Aciphex Sprinkle, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Aciphex Sprinkle's generic
Alternative Brands for Aciphex Sprinkle
Aciphex Sprinkle which is used for treating peptic ulcers., has several other brand drugs in the same treatment category and using the same active ingredient (Rabeprazole Sodium). 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 | Treatment Area | ||
|---|---|---|---|---|
| Waylis Therap |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Rabeprazole Sodium, Aciphex Sprinkle's active ingredient. Check the complete list of approved generic manufacturers for Aciphex Sprinkle
About Aciphex Sprinkle
Aciphex Sprinkle is a drug owned by Aytu Bioscience Inc. It is used for treating peptic ulcers. Aciphex Sprinkle uses Rabeprazole Sodium as an active ingredient. Aciphex Sprinkle was launched by Aytu in 2013.
Approval Date:
Aciphex Sprinkle was approved by FDA for market use on 26 March, 2013.
Active Ingredient:
Aciphex Sprinkle uses Rabeprazole Sodium as the active ingredient. Check out other Drugs and Companies using Rabeprazole Sodium ingredient
Treatment:
Aciphex Sprinkle is used for treating peptic ulcers.
Dosage:
Aciphex Sprinkle is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | CAPSULE, DELAYED RELEASE | Discontinued | ORAL |
| 10MG | CAPSULE, DELAYED RELEASE | Discontinued | ORAL |