Metozolv Odt is a drug owned by Salix 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 Jul 11, 2017. Details of Metozolv Odt'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). | |||
| US6413549 | Fast-Dispersing solid oral dosage form containing coarse particles |
Jul, 2017
(7 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Metozolv Odt 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 Metozolv Odt's family patents as well as insights into ongoing legal events on those patents.
Metozolv Odt's Family Patents
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Generic Launch
Generic Release Date:
Metozolv Odt's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 11, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Metozolv Odt Generic API suppliers:
Metoclopramide Hydrochloride is the generic name for the brand Metozolv Odt. 38 different companies have already filed for the generic of Metozolv Odt, with Hospira having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Metozolv Odt's generic
How can I launch a generic of Metozolv Odt before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Metozolv Odt's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Metozolv Odt'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 Metozolv Odt -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg and 10 mg | 24 Aug, 2010 | 1 | 15 Aug, 2014 | 11 Jul, 2017 | Extinguished Deferred |
Alternative Brands for Metozolv Odt
Metozolv Odt which is used for multiple sclerosis, Crohn's disease, ulcerative colitis, rheumatoid arthritis, and psoriasis., has several other brand drugs using the same active ingredient (Metoclopramide Hydrochloride). 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 | |
|---|---|---|
| Evoke Pharma Inc |
| |
| Meda Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Metoclopramide Hydrochloride, Metozolv Odt's active ingredient. Check the complete list of approved generic manufacturers for Metozolv Odt
About Metozolv Odt
Metozolv Odt is a drug owned by Salix Pharmaceuticals Inc. It is used for multiple sclerosis, Crohn's disease, ulcerative colitis, rheumatoid arthritis, and psoriasis. Metozolv Odt uses Metoclopramide Hydrochloride as an active ingredient. Metozolv Odt was launched by Salix Pharms in 2009.
Approval Date:
Metozolv Odt was approved by FDA for market use on 04 September, 2009.
Active Ingredient:
Metozolv Odt uses Metoclopramide Hydrochloride as the active ingredient. Check out other Drugs and Companies using Metoclopramide Hydrochloride ingredient
Treatment:
Metozolv Odt is used for multiple sclerosis, Crohn's disease, ulcerative colitis, rheumatoid arthritis, and psoriasis.
Dosage:
Metozolv Odt 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |