Aciphex is a drug owned by Waylis Therapeutics Llc. 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 Nov 08, 2013. Details of Aciphex'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
|
US patents provide insights into the exclusivity only within the United States, but Aciphex 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's family patents as well as insights into ongoing legal events on those patents.
Aciphex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aciphex's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 08, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aciphex Generic API suppliers:
Rabeprazole Sodium is the generic name for the brand Aciphex. 10 different companies have already filed for the generic of Aciphex, 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's generic
How can I launch a generic of Aciphex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Aciphex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Aciphex'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 Aciphex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg |
Alternative Brands for Aciphex
Aciphex 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 | ||
|---|---|---|---|---|
| Aytu |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Rabeprazole Sodium, Aciphex's active ingredient. Check the complete list of approved generic manufacturers for Aciphex
About Aciphex
Aciphex is a drug owned by Waylis Therapeutics Llc. It is used for treating peptic ulcers. Aciphex uses Rabeprazole Sodium as an active ingredient. Aciphex was launched by Waylis Therap in 2002.
Approval Date:
Aciphex was approved by FDA for market use on 29 May, 2002.
Active Ingredient:
Aciphex uses Rabeprazole Sodium as the active ingredient. Check out other Drugs and Companies using Rabeprazole Sodium ingredient
Treatment:
Aciphex is used for treating peptic ulcers.
Dosage:
Aciphex is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE | Discontinued | ORAL |
| 20MG | TABLET, DELAYED RELEASE | Prescription | ORAL |