Mepron is a drug owned by Glaxosmithkline Llc. 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 Jan 10, 2017. Details of Mepron'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). | |||
|
US6649659 (Pediatric) | Atovaquone pharmaceutical compositions |
Jan, 2017
(7 years ago) |
Expired
|
| US6649659 | Atovaquone pharmaceutical compositions |
Jul, 2016
(8 years ago) |
Expired
|
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Mepron and ongoing litigations to help you estimate the early arrival of Mepron generic.
Mepron's Litigations
Mepron been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 25, 2002, against patent number US6649659. The petitioner , challenged the validity of this patent, with DEARN as the respondent. Click below to track the latest information on how companies are challenging Mepron's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6649659 | April, 2002 |
Decision
(30 Jun, 2003) | DEARN | |
US patents provide insights into the exclusivity only within the United States, but Mepron 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 Mepron's family patents as well as insights into ongoing legal events on those patents.
Mepron's Family Patents
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Generic Launch
Generic Release Date:
Mepron's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 10, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mepron Generic API suppliers:
Atovaquone is the generic name for the brand Mepron. 9 different companies have already filed for the generic of Mepron, with Abhai Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Mepron's generic
How can I launch a generic of Mepron before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Mepron's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mepron'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 Mepron -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 750 mg/5 mL | 20 Oct, 2009 | 1 | Extinguished |
Alternative Brands for Mepron
Mepron which is used for treating Pneumocystis carinii infections., has several other brand drugs using the same active ingredient (Atovaquone). 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 | ||
|---|---|---|---|
| Glaxosmithkline |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Atovaquone, Mepron's active ingredient. Check the complete list of approved generic manufacturers for Mepron
About Mepron
Mepron is a drug owned by Glaxosmithkline Llc. It is used for treating Pneumocystis carinii infections. Mepron uses Atovaquone as an active ingredient. Mepron was launched by Glaxosmithkline Llc in 1995.
Approval Date:
Mepron was approved by FDA for market use on 08 February, 1995.
Active Ingredient:
Mepron uses Atovaquone as the active ingredient. Check out other Drugs and Companies using Atovaquone ingredient
Treatment:
Mepron is used for treating Pneumocystis carinii infections.
Dosage:
Mepron is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 750MG/5ML | SUSPENSION | Prescription | ORAL |