Malarone is a drug owned by Glaxosmithkline. It is protected by 6 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 May 25, 2014. Details of Malarone'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). | |||
|
US6291488 (Pediatric) | Preventing protozoal infections |
May, 2014
(10 years ago) |
Expired
|
|
US5998449 (Pediatric) | Combination of atovaquone with proguanil for the treatment of protozoal infections |
May, 2014
(10 years ago) |
Expired
|
|
US6166046 (Pediatric) | Combination of atovaquone with proguanil for the treatment of protozoal infections |
May, 2014
(10 years ago) |
Expired
|
| US6291488 | Preventing protozoal infections |
Nov, 2013
(11 years ago) |
Expired
|
| US5998449 | Combination of atovaquone with proguanil for the treatment of protozoal infections |
Nov, 2013
(11 years ago) |
Expired
|
| US6166046 | Combination of atovaquone with proguanil for the treatment of protozoal infections |
Nov, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Malarone 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 Malarone's family patents as well as insights into ongoing legal events on those patents.
Malarone's Family Patents
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Generic Launch
Generic Release Date:
Malarone's generic launch date based on the expiry of its last outstanding patent is estimated to be May 25, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Malarone Generic API suppliers:
Atovaquone; Proguanil Hydrochloride is the generic name for the brand Malarone. 2 different companies have already filed for the generic of Malarone, with Glenmark Pharms Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Malarone's generic
How can I launch a generic of Malarone before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Malarone's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Malarone'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 Malarone -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 62.5 mg/25 mg | 14 Sep, 2010 | 1 | 27 May, 2014 | 25 Nov, 2013 | Extinguished |
| 250 mg/100 mg | 03 Apr, 2009 | 1 | 12 Jan, 2011 | 25 Nov, 2013 | Eligible |
Alternative Brands for Malarone
Malarone which is used for treating protozoal infections., has several other brand drugs in the same treatment category and using the same active ingredient (Atovaquone; Proguanil 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 | Treatment Area | ||
|---|---|---|---|---|
| Glaxosmithkline |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Atovaquone; Proguanil Hydrochloride, Malarone's active ingredient. Check the complete list of approved generic manufacturers for Malarone
About Malarone
Malarone is a drug owned by Glaxosmithkline. It is used for treating protozoal infections. Malarone uses Atovaquone; Proguanil Hydrochloride as an active ingredient. Malarone was launched by Glaxosmithkline in 2000.
Approval Date:
Malarone was approved by FDA for market use on 14 July, 2000.
Active Ingredient:
Malarone uses Atovaquone; Proguanil Hydrochloride as the active ingredient. Check out other Drugs and Companies using Atovaquone; Proguanil Hydrochloride ingredient
Treatment:
Malarone is used for treating protozoal infections.
Dosage:
Malarone is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG;100MG | TABLET | Prescription | ORAL |