Targeting Various Therapeutic Areas with New and Generic Products

Our product portfolio includes both new products, which follow a New Drug Application (NDA) 505(b)(2) FDA regulatory pathway, and controlled-release generic products, which follow an Abbreviated New Drug Application (ANDA) pathway. Therapeutic areas covered by our portfolio include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.

Product Pipeline

Product Indication Clinical/BE Studies FDA Filed FDA Approved
Oxycodone hydrochloride ER Pain Phase complete Phase in progress Phase not started
Regabatin™ Neuropathic Pain Phase in progress Phase not started Phase not started
Dexmethylphenidate ADHD Phase complete Phase complete Phase in progress
Metformin Diabetes Phase complete Phase complete Phase in progress
Venlafaxine Depression Phase complete Phase complete Phase in progress
Pantoprazole GERD Phase complete Phase in progress Phase not started
Quetiapine Schizophrenia Phase complete Phase complete Phase in progress
Lamotrigine Epilepsy Phase complete Phase in progress Phase not started

Source:Represents sales for all strengths, unless otherwise noted, for the 12 months ended May 2019 in the US., including sales of generics in TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer’s published catalog or list prices to wholesalers, and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price. Source: Symphony Health Solutions Corporation. The information attributed to Symphony Health Solutions Corporation herein is provided as is, and Symphony makes no representation and/or warranty of any kind, including but not limited to, the accuracy and/or completeness of such information

Control Release Delivery Platforms

  • Oxycodone hydrochloride ER (formerly known as Rexista™)

    One of our key non-generic development products is Oxycodone hydrochloride ER, an abuse- and alcohol-resistant, extended-release oral oxycodone formulation. Oxycodone hydrochloride ER is designed to discourage common methods of tampering associated with misuse and abuse of prescription opioid analgesics.

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  • Regabatin

    Another of our non-generic controlled-release products is Regabatin™ extended-release capsules. Our once a day extended-release version of pregabalin may potentially improve patient compliance, and clinical outcomes.

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  • ANDA Candidates

    We formulate complex extended-release generic products, which are bioequivalent to the branded products. Such products can be licensed to and sold by distributors of generic products. Our scientists have previously demonstrated a successful track record with such products, having developed several drugs on a private contract basis. The regulatory pathway for this approach requires an abbreviated new drug application ("ANDA").

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