Coartem is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Coartem's patents have been open to challenges since 07 April, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 07, 2016. Details of Coartem'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). | |||
| US5677331 | Antimalarial compositions |
Oct, 2014
(10 years ago) |
Expired
|
FDA has granted several exclusivities to Coartem. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Coartem, 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 Coartem.
Exclusivity Information
Coartem holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Coartem's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 07, 2014 |
| Orphan Drug Exclusivity(ODE) | Apr 07, 2016 |
US patents provide insights into the exclusivity only within the United States, but Coartem 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 Coartem's family patents as well as insights into ongoing legal events on those patents.
Coartem's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Coartem's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 07, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Coartem Generics:
There are no approved generic versions for Coartem as of now.
About Coartem
Coartem is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating acute, uncomplicated malaria infection caused by Plasmodium falciparum in patients weighing 5kg and above. Coartem uses Artemether; Lumefantrine as an active ingredient. Coartem was launched by Novartis in 2009.
Approval Date:
Coartem was approved by FDA for market use on 07 April, 2009.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Coartem is 07 April, 2009, its NCE-1 date is estimated to be 07 April, 2013.
Active Ingredient:
Coartem uses Artemether; Lumefantrine as the active ingredient. Check out other Drugs and Companies using Artemether; Lumefantrine ingredient
Treatment:
Coartem is used for treating acute, uncomplicated malaria infection caused by Plasmodium falciparum in patients weighing 5kg and above.
Dosage:
Coartem is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG;120MG | TABLET | Prescription | ORAL |