1. SunGen ANDA #2 $1.6 Billion dollar market with one Name Brand and 3 generic competitors.FDA filed and under review. Approval in 10-12 months
Quote Nasrat: “The last ANDA that was filed in May was an extended-release CNS stimulant that we co-developed with our partner SunGen. The branded and generic sales of this product are approximately $1.6 BILLION and there are currently just FOUR manufacturers which includes the branded and its authorized generics.“
2. SunGen ANDA #3 Bigger than SunGen #2 greater than $1.6 Billion Market unknown number of competitors at this time.
Quote Nasrat : “We have another product (SunGen ANDA #3) that we're partnering with SunGen, that’s bigger than this one (SunGen ANDA #2).”
3. Reformulated Patented SequestOx will be the first ADF Immediate Release(IR) Opioid that will have Oral (chewing), Intranasal, and Intravenous(IV) Abuse Deterrent Labeling. New patent to extend exclusivity Elite will own the market
4. Unique Patented Novel ADF (new technology) which is 90% cheaper than the competitions
Quote Nasrat: on new ADF platform “I am extremely excited about this formulation because it is also a platform that applies to all the IRs and its about 10% of the cost. So we're extremely excited about this, but it's still early, in the next few months once Dr. Smith files a patent and we do a few more trials, we’ll update everyone more about it. “
5. Generic ADF OxyContin will the First Ever Generic ADF Opioid : Filed Sept 2017 and under review by FDA
FDA will back up the DOJ Quote: “The FDA outlined several steps for speeding up the development of generic abuse-deterrent opioids. The agency plans to help companies navigate the regulatory process in order to produce abuse-deterrent opioids sooner. In its guidance, the FDA also provided recommendations for the types of studies that drugmakers could do to ensure that generic drugs are just as abuse-deterrent as brand-name versions. Gottlieb emphasized that this isn’t a push by the FDA to “encourage more opioid use.” Instead, the agency hopes to shift opioid prescribing toward abuse-deterrent versions .”
50¢Land Catalyst
9. SunGen ANDA #1 Generic Adderall Immediate Release Stimulant for ADHD with $400 million market 9-10 competitors Filed Feb 2018