Razadyne Er is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 20, 2019. Details of Razadyne Er'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). | |||
| US7160559 | Controlled release galantamine composition |
Dec, 2019
(5 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 Razadyne Er's patents.
Latest Legal Activities on Razadyne Er's Patents
Given below is the list of recent legal activities going on the following patents of Razadyne Er.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Jun, 2018 | US7160559 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Jan, 2007 | US7160559 |
| Recordation of Patent Grant Mailed Critical | 09 Jan, 2007 | US7160559 |
| Issue Notification Mailed Critical | 20 Dec, 2006 | US7160559 |
| Dispatch to FDC | 06 Dec, 2006 | US7160559 |
| Mail Miscellaneous Communication to Applicant | 30 Nov, 2006 | US7160559 |
| Miscellaneous Communication to Applicant - No Action Count | 25 Nov, 2006 | US7160559 |
| Mail-Petition Decision - Dismissed Critical | 19 Sep, 2006 | US7160559 |
| Application Is Considered Ready for Issue Critical | 04 May, 2006 | US7160559 |
| Issue Fee Payment Verified Critical | 27 Apr, 2006 | US7160559 |
US patents provide insights into the exclusivity only within the United States, but Razadyne Er 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 Er's family patents as well as insights into ongoing legal events on those patents.
Razadyne Er's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Razadyne Er's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 20, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Razadyne Er Generic API suppliers:
Galantamine Hydrobromide is the generic name for the brand Razadyne Er. 16 different companies have already filed for the generic of Razadyne Er, with Norvium Bioscience having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Razadyne Er's generic
How can I launch a generic of Razadyne Er before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Razadyne Er's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Razadyne Er'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 Er -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 8 mg | 02 Mar, 2006 | 1 | 15 Sep, 2008 | 20 Dec, 2019 | Eligible |
| 16 mg and 24 mg | 11 Mar, 2006 | 1 | 15 Sep, 2008 | 20 Dec, 2019 | Eligible |
Alternative Brands for Razadyne Er
There are several other brand drugs using the same active ingredient (Galantamine Hydrobromide) as Razadyne Er. 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 | |
|---|---|---|
| Janssen Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Galantamine Hydrobromide, Razadyne Er's active ingredient. Check the complete list of approved generic manufacturers for Razadyne Er
About Razadyne Er
Razadyne Er is a drug owned by Janssen Pharmaceuticals Inc. Razadyne Er uses Galantamine Hydrobromide as an active ingredient. Razadyne Er was launched by Janssen Pharms in 2005.
Approval Date:
Razadyne Er was approved by FDA for market use on 01 April, 2005.
Active Ingredient:
Razadyne Er uses Galantamine Hydrobromide as the active ingredient. Check out other Drugs and Companies using Galantamine Hydrobromide ingredient
Dosage:
Razadyne Er is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |