Datscan is a drug owned by Ge Healthcare Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Datscan's patents have been open to challenges since 14 January, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 14, 2016. Details of Datscan'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). | |||
| US5310912 | Iodinated neuroprobe for mapping monoamine reuptake sites |
Feb, 2013
(11 years ago) |
Expired
|
FDA has granted several exclusivities to Datscan. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Datscan, 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 Datscan.
Exclusivity Information
Datscan holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Datscan's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 14, 2016 |
US patents provide insights into the exclusivity only within the United States, but Datscan 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 Datscan's family patents as well as insights into ongoing legal events on those patents.
Datscan's Family Patents
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Generic Launch
Generic Release Date:
Datscan's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 14, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Datscan Generic API suppliers:
Ioflupane I-123 is the generic name for the brand Datscan. 1 company has already filed for the generic of Datscan. Check out the entire list of companies who have already received approval for Datscan's generic
About Datscan
Datscan is a drug owned by Ge Healthcare Inc. Datscan uses Ioflupane I-123 as an active ingredient. Datscan was launched by Ge Hlthcare Inc in 2011.
Approval Date:
Datscan was approved by FDA for market use on 14 January, 2011.
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 Datscan is 14 January, 2011, its NCE-1 date is estimated to be 14 January, 2015.
Active Ingredient:
Datscan uses Ioflupane I-123 as the active ingredient. Check out other Drugs and Companies using Ioflupane I-123 ingredient
Dosage:
Datscan is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5mCi/2.5ML (2mCi/ML) | SOLUTION | Prescription | INTRAVENOUS |