Razadyne is a drug owned by Janssen Pharmaceuticals 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 Jun 06, 2017. Details of Razadyne'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). | |||
| US6099863 | Fast-dissolving galanthamine hydrobromide tablet |
Jun, 2017
(7 years ago) |
Expired
|
| US6358527 | Fast-dissolving galanthamine hydrobromide tablet |
Jun, 2017
(7 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Razadyne 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 Razadyne's family patents as well as insights into ongoing legal events on those patents.
Razadyne's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Razadyne's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 06, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Razadyne Generic API suppliers:
Galantamine Hydrobromide is the generic name for the brand Razadyne. 16 different companies have already filed for the generic of Razadyne, with Norvium Bioscience having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Razadyne's generic
How can I launch a generic of Razadyne before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Razadyne's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Razadyne'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 Razadyne -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 4 mg, 8 mg and 12 mg | 28 Feb, 2005 | 14 | 28 Aug, 2008 | 06 Jun, 2017 | Eligible |
Alternative Brands for Razadyne
Razadyne which is used for treating Alzheimer's dementia., has several other brand drugs in the same treatment category and using the same active ingredient (Galantamine Hydrobromide). 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.
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Galantamine Hydrobromide. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Janssen Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Galantamine Hydrobromide, Razadyne's active ingredient. Check the complete list of approved generic manufacturers for Razadyne
About Razadyne
Razadyne is a drug owned by Janssen Pharmaceuticals Inc. It is used for treating Alzheimer's dementia. Razadyne uses Galantamine Hydrobromide as an active ingredient. Razadyne was launched by Janssen Pharms in 2001.
Approval Date:
Razadyne was approved by FDA for market use on 28 February, 2001.
Active Ingredient:
Razadyne uses Galantamine Hydrobromide as the active ingredient. Check out other Drugs and Companies using Galantamine Hydrobromide ingredient
Treatment:
Razadyne is used for treating Alzheimer's dementia.
Dosage:
Razadyne is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |