Neoral 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. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 26, 2014. Details of Neoral'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). | |||
| US5985321 | Soft gelatin capsule manufacture |
Sep, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Neoral 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 Neoral's family patents as well as insights into ongoing legal events on those patents.
Neoral's Family Patents
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Clinical Trials
Recent Clinical Trials on Neoral:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Neoral(Cyclosporine) has 1 clinical trial that has been verified in 2024.
Generic Launch
Generic Release Date:
Neoral's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 26, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Neoral Generic API suppliers:
Cyclosporine is the generic name for the brand Neoral. 14 different companies have already filed for the generic of Neoral, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Neoral's generic
Alternative Brands for Neoral
There are several other brand drugs using the same active ingredient (Cyclosporine) as Neoral. 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 | ||
|---|---|---|---|
| Abbvie |
| ||
| Harrow Eye |
| ||
| Sun Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Cyclosporine, Neoral's active ingredient. Check the complete list of approved generic manufacturers for Neoral
About Neoral
Neoral is a drug owned by Novartis Pharmaceuticals Corp. Neoral uses Cyclosporine as an active ingredient. Neoral was launched by Novartis in 1995.
Approval Date:
Neoral was approved by FDA for market use on 14 July, 1995.
Active Ingredient:
Neoral uses Cyclosporine as the active ingredient. Check out other Drugs and Companies using Cyclosporine ingredient
Dosage:
Neoral is available in the following dosage forms - solution form for oral use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | CAPSULE | Prescription | ORAL |
| 100MG/ML | SOLUTION | Prescription | ORAL |
| 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |
| 100MG | CAPSULE | Prescription | ORAL |