1. SunGen ANDA #2-THE MONSTER $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.“
Quote N2K: “For a product entering a growth market with existing product with market leaders having more than a three year lead time,there has been a first year average market capture of 8.7%. If we extrapolate that to Elite and the CNS ER product for the $1.6 B market it is (that's right) $139.2 Million in the first year.”
3. Reformulated Patent Pending SequestOx-THE BEAST 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 Patent Pending Novel ADF-THE GOLIATH (new drug platform) 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-THE BEHEMOTH will the First Ever Generic ADF Opioid : Filed Sept 2017 and under review by FDA
6. Isradipine -THE WILDCARD : Approved and Launched Positive Isradipine-Parkinson PH III Study ONE competitor 1 million patients Study nearly completed. https://clinicaltrials.gov/ct2/show/NCT02168842
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