Product Pipeline

A unique and robust product pipeline built upon a proven track record

Product Pipeline

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 Brand US Sales Indication Clinical/BE Studies FDA Filed FDA Approved
NDA
Oxycodone hydrochloride ER OxyContin® $1.94B* Pain
Clinical/BE Studies Phase complete
FDA Filed Phase in progress
FDA Approved Phase not started
Regabatin™ Lyrica® $4.57B* Neuropathic Pain
Clinical/BE Studies Phase in progress
FDA Filed Phase not started
FDA Approved Phase not started
ANDA
Dexmethylphenidate Focalin XR® $802M* ADHD
Clinical/BE Studies Phase complete
FDA Filed Phase complete
Partnered with PAR
FDA Approved Phase in progress
Metformin Glucophage® XR $528M* Diabetes
Clinical/BE Studies Phase complete
FDA Filed Phase complete
Available for Partnering
FDA Approved Phase in progress
Venlafaxine Effexor XR® $693M* Depression
Clinical/BE Studies Phase complete
FDA Filed Phase in progress
FDA Approved Phase not started
Pantoprazole Prototonix® $337M* GERD
Clinical/BE Studies Phase complete
FDA Filed Phase in progress
FDA Approved Phase not started
Quetiapine Seroquel XR® $557M* Schizophrenia
Clinical/BE Studies Phase complete
FDA Filed Phase complete
Partnered with Mallinckrodt
FDA Approved Phase in progress
Lamotrigine Lamictal®XR™ $531M* Epilepsy
Clinical/BE Studies Phase complete
FDA Filed Phase in progress
Partnered with Mallinckrodt
FDA Approved Phase not started
Levetiracetam Keppra XR® $134M* Epilepsy
Clinical/BE Studies Phase complete
FDA Filed Phase complete
Available for Partnering
FDA Approved Phase in progress
Desvenlafaxine Pristiq® $582M* Depression
Clinical/BE Studies Phase complete
FDA Filed Phase in progress
Partnered with Mallinckrodt
FDA Approved Phase not started
Ranolazine Ranexa® $926M* Chronic Angina
Clinical/BE Studies Phase complete
FDA Filed Phase in progress
FDA Approved Phase not started
Carvedilol Coreg CR® $214M* Heart failure, Hypertension
Clinical/BE Studies Phase in progress
FDA Filed Phase not started
FDA Approved Phase not started

Source: Represents sales for all strengths, unless otherwise noted, for the 12 months ended August 2017 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.