ANDA Candidates: A Clear Path to Approval

Our Hypermatrix technology allows for the intelligent and efficient design of drugs through the precise manipulation of a number of key variables. This allows us to respond to varying drug attributes and patient requirements, producing a desired controlled-release effect in a time and cost-effective manner. Our pipeline of complex extended-release generic products are specifically targeted for launch into high need markets.

Product US Market Size Indication Clinical/BE Studies FDA Filed FDA Approved
ANDA
Dexmethylphenidate $867M* ADHD Phase Complete
Metformin $210M* Diabetes Phase Complete
Venlafaxine $803M* Depression Phase Complete
Pantoprazole $375M* GERD Phase Complete
Quetiapine $153M* Schizophrenia Phase Complete
Lamotrigine $518M* Epilepsy Phase Complete
Levetiracetam $130M* Epilepsy Phase Complete
Desvenlafaxine $275M* Depression Phase Complete
Ranolazine $997M* Chronic Angina Phase Complete
Carvedilol $260M* Heart failure, Hypertension Phase Complete

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

Generic Dexmethylphenidate Hydrochloride Extended-Release

Our lead generic product candidate, dexmethylphenidate hydrochloride, is a Schedule II (drugs with a high potential for abuse) medication used for the treatment of ADHD (attention deficit hyperactivity disorder).

In November 2013, the U.S. Food and Drug Administration (FDA) granted final approval of our dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths. Commercial sales of these strengths were launched immediately by our commercialization partner in the U.S., Par Pharmaceutical. The FDA has also approved the 5, 10, 15, 20, 25, 30 35 and 40 mg strengths under the Par ANDA. Par has launched the 10, 20, 25, and 35 mg strengths in 2017, and we expect Par to launch the 5 and 40 mg strengths in the near future.

Under a license and commercialization agreement between the Company and Par (as amended, the "Par agreement"), the Company receives quarterly profit-share payments on Par's U.S. sales of dexmethylphenidate hydrochloride.

According to Symphony Health Solutions, sales for the 12 months ended May 2019 of Focalin XR® in the U.S. were approximately $867 million (TRx MBS Dollars).

Generic Venlafaxine Hydrochloride Extended-Release

Our second generic product in our pipeline is venlafaxine hydrochloride extended release capsules.

In November 2018 the company announced the receipt of final approval from the U.S. Food and Drug Administration ("FDA") for the Company's abbreviated new drug application ("ANDA") for venlafaxine hydrochloride extended-release capsules in the 37.5, 75, and 150 mg strengths.

Venlafaxine Hydrochloride Extended-Release is indicated for the treatment of symptoms of major depressive disorder, generalized anxiety disorder, social anxiety disorder and panic disorder.

According to Symphony Health Solutions, sales of venlafaxine hydrochloride extended-release capsules in the U.S. were approximately US$803 million for the 12 months ended May 2019 (TRx MBS Dollars).

Generic Pantoprazole Extended-Release

Pantoprazole extended-release is a delayed release pantoprazole sodium. This product is currently the subject of an ANDA filing with the FDA and is available for partnering.

Pantoprazole extended-release is a delayed-release capsule for oral administration that contains pantoprazole sodium. Pantoprazole extended-release inhibits gastric acid secretion and is prescribed for the short-term treatment of conditions such as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.

According to Symphony Health Services, sales of pantoprazole sodium delayed-release tablets in the United States were approximately US$375 million for the 12 months ending May 2019 (TRx MBS Dollars).

Generic Metformin Hydrochloride Extended-Release

In February 2017 the FDA granted approval of our generic metformin hydrochloride extended-release capsules for the 500 mg and 750 mg strengths and this product is available for partnering.

The approved product is a generic equivalent for the corresponding strengths of the branded product Glucophage XR® sold in North America by Merck-Santé S.A.S.

Metformin hydrochloride extended-release is an oral antihyperglycemia drug used in the management of type 2 diabetes. According to Symphony Health Solutions, sales of metformin hydrochloride extended-release were approximately US$210 million for the 12 months ending May 2019 (TRx MBS Dollars).

Generic Quetiapine Fumarate Extended-Release

Another product candidate in our generics pipeline is quetiapine fumarate extended-release capsules. In May 2017, the FDA granted final approval of our quetiapine fumarate extended release capsules in the 50, 150, 200, 300 and 400 mg strengths.

In August 2019, the Company announced a licensing and commercial supply agreement with Tris Pharma, Inc. ("Tris"), by which the Company has granted Tris an exclusive license to market, sell and distribute in the United States, Quetiapine ER in the 50, 150, 200, 300 and 400 mg strengths (the "licensed products") approved for sale in the US market by the U.S. Food and Drug Administration ("FDA").

Quetiapine fumarate is an oral psychotropic agent indicated for the treatment of schizophrenia, bipolar disorder, and major depressive disorder. According to Symphony Health Solutions, sales of generic quetiapine fumarate extended-release were approximately US$153 million for the 12 months ending May 2019 (TRx MBS Dollars).

Generic Lamotrigine Extended-Release

A sixth product candidate in our generics pipeline is lamotrigine extended-release tablets. This product is currently the subject of an Abbreviated New Drug Application (ANDA) filing with the FDA.

Lamotrigine is an anticonvulsant drug used in the treatment of epilepsy. According to Symphony Health Solutions, U.S. sales of lamotrigine extended-release were approximately US$518 million for the 12 months ending May 2019 (TRx MBS Dollars).

Generic Levetiracetam Extended-Release

A seventh product candidate in our generics pipeline is levetiracetam extended-release tablets. On February 23, 2016, the FDA granted final approval of the Company's levetiracetam extended-release tablets for the 500 mg and 750 mg strengths and this drug is available for partnering.

Levetiracetam is an antiepileptic drug indicated for the treatment of partial onset seizures in patients with epilepsy. According to Symphony Health Solutions, U.S. sales of levetiracetam extended-release tablets for the 12 months ending May 2019 were approximately $130 million (TRx MBS Dollars).

Generic Desvenlafaxine Extended-Release

An eighth product candidate in our generics pipeline is desvenlafaxine extended-release tablets.

In May 2019 the company announced the FDA approval of the Abbreviated New Drug Application (ANDA) filing for extended-release tablets in the 50 and 100 mg strengths.

In September 2019, the Company announced a licensing and commercial supply agreement with Tris Pharma, Inc. ("Tris"), by which the Company granted Tris an exclusive license to market, sell and distribute in the United States, Desvenlafaxine Succinate ER in the 50 and 100 mg strengths (the "licensed products") approved for sale in the U.S. market by the U.S. Food and Drug Administration ("FDA").

Desvenlafaxine is a selective serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder. According to Symphony Health Solutions, U.S. sales for the 12 months ending May 2019 for desvenlafaxine extended-release were approximately $275 million (TRx MBS Dollars).

Generic Ranolazine Extended-Release

A ninth product candidate in our generics pipeline is ranolazine extended-release tablets. This product is currently the subject of an Abbreviated New Drug Application (ANDA) filing with the FDA and is available for partnering.

Ranolazine is a is an anti-anginal medication indicated for the treatment of chronic angina. According to Symphony Health Solutions, U.S. sales for the 12 months ending May 2019 for ranolazine extended-release were approximately $997 million (TRx MBS Dollars).

Generic Carvedilol Phosphate Extended-Release

A tenth product candidate in our generics pipeline is carvedilol phosphate extended-release capsules. It is used in the treatment of heart failure and hypertension.  According to Symphony Health Solutions U.S. sales for Carvedilol Phosphate were approximately US$260 million for the 12 months ending May 2019 (TRx MBS Dollars).


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.