Maxalt-mlt is a drug owned by Organon Llc A Sub Of Organon And Co. It is protected by 4 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 16, 2015. Details of Maxalt-mlt'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). | |||
|
US5457895 (Pediatric) | Method of identifying freeze-dried dosage forms |
Apr, 2014
(10 years ago) |
Expired
|
| US5457895 | Method of identifying freeze-dried dosage forms |
Oct, 2013
(11 years ago) |
Expired
|
|
US5298520 (Pediatric) | Triazole containing indole derivatives |
Dec, 2012
(11 years ago) |
Expired
|
|
US5602162 (Pediatric) | Imidazole, triazole and tetrazole derivatives |
Jul, 2012
(12 years ago) |
Expired
|
FDA has granted several exclusivities to Maxalt-mlt. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Maxalt-mlt, 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 Maxalt-mlt.
Exclusivity Information
Maxalt-mlt holds 2 exclusivities. All of its exclusivities have expired in 2015. Details of Maxalt-mlt's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Dec 16, 2014 |
| Pediatric Exclusivity(PED) | Jun 16, 2015 |
US patents provide insights into the exclusivity only within the United States, but Maxalt-mlt 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 Maxalt-mlt's family patents as well as insights into ongoing legal events on those patents.
Maxalt-mlt's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Maxalt-mlt's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 16, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Maxalt-mlt Generic API suppliers:
Rizatriptan Benzoate is the generic name for the brand Maxalt-mlt. 17 different companies have already filed for the generic of Maxalt-mlt, with Unichem having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Maxalt-mlt's generic
How can I launch a generic of Maxalt-mlt before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Maxalt-mlt's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Maxalt-mlt'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 Maxalt-mlt -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg and 10 mg | 17 Feb, 2006 | 1 | 31 Dec, 2012 | 11 Feb, 2014 | Eligible |
Alternative Brands for Maxalt-mlt
There are several other brand drugs using the same active ingredient (Rizatriptan Benzoate) as Maxalt-mlt. 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 brand drugs containing the same ingredient, some generics have also been filed for Rizatriptan Benzoate, Maxalt-mlt's active ingredient. Check the complete list of approved generic manufacturers for Maxalt-mlt
About Maxalt-mlt
Maxalt-Mlt is a drug owned by Organon Llc A Sub Of Organon And Co. Maxalt-Mlt uses Rizatriptan Benzoate as an active ingredient. Maxalt-Mlt was launched by Organon in 1998.
Approval Date:
Maxalt-mlt was approved by FDA for market use on 29 June, 1998.
Active Ingredient:
Maxalt-mlt uses Rizatriptan Benzoate as the active ingredient. Check out other Drugs and Companies using Rizatriptan Benzoate ingredient
Dosage:
Maxalt-mlt is available in tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING | Prescription | ORAL |
| EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |