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Post by figglebird on Feb 10, 2016 20:21:43 GMT -5
Can anyone elaborate how June 2017 would possibly be viable in any way for a generic version of Afrezza WITHOUT the technology transfer OR understanding of how TS works in the manufacturing process? I assume it would not, otherwise why wouldn't someone just have done the same thing with Exhubra etc - minus the formulation. www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=022472&Product_No=002&table1=OB_RxApologize for any confusion if you don't get what I asking - there is a chance I may not either. |
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Post by dreamboatcruise on Feb 10, 2016 20:39:29 GMT -5
Can anyone elaborate how June 2017 would possibly be viable in any way for a generic version of Afrezza WITHOUT the technology transfer OR understanding of how TS works in the manufacturing process? I assume it would not, otherwise why wouldn't someone just have done the same thing with Exhubra etc - minus the formulation. www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=022472&Product_No=002&table1=OB_RxApologize for any confusion if you don't get what I asking - there is a chance I may not either. I believe that is an exclusivity based on FDA regulation which is in addition to any patents. Though it is unclear to me what the meaning of this exclusivity would be... i.e. what products it would keep off the market if any. If the patents are sound they would provide protection beyond this FDA provided exclusivity. [caveat, I could be wrong] |
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Post by figglebird on Feb 10, 2016 22:47:02 GMT -5
You are off from what I understand but it is heavily worded so not that easy to understand - exclusivity option has to do w a competitor's ability to file for a generic version of an NDA which is called an MNDA(regardless of patent) and would require no further testing after a requirement testing that the original NDA did they can do this is true regards one being a challenge that the patent infringing on prior patents or 2 that the patent is legitimate in which case the nda holder has to file suit from what I understand that the party looking to file a generic version is infringing on their rights it is a little confusing because it's based on various factors such as new compounds pre existing compounds which in this case would be human insulin dosage in but it does not mention the idea of formulation its confusing but probably important from what I gather...
Important because it basically asserts that any company such as sanofi good in 2017 begin the process of a generic version of a Fresno what's confusing is how is that possible if they don't have Technosphere technology it doesn't seem to be covered under the law that this specific exclusivity option was detailed in 1997
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Post by matt on Feb 11, 2016 9:11:58 GMT -5
The FDA grants a period of exclusivity separate from patent law. Since it often takes so long to get through the FDA process, some companies are up against patent deadlines by the time their medication hits the market so this provision gives an innovator at least some protection. Because it is the FDA, this exclusivity period has no effect elsewhere. To understand what a competitor must do to market a generic, you have to research each of the patents listed as these may, or may not, be used in the manufacture of Afrezza.
If the patent on the composition of matter for a small molecule has expired, but patents on method of manufacture have not, a competitor could figure out a different production method to synthesize the same molecule. Generic drug companies excel at this and could figure out a way to get to a powered recombinant human insulin, although it would be a bit more tricky than a typical small molecule drug. In the case of Afrezza, they would also need to have their own inhaler device, dosing canisters, and so on that did not infringe on any unexpired patents.
However, that last part is a purely commercial issue and not one for the FDA; once the period stated in the Orange Book expires then FDA will grant the generic a marketing license. If there are other patent issues that is a matter for the District Court to decide. The purpose of the Orange Book is to communicate the first date at which a generic for a particular drug will be considered for FDA registration, nothing more.
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