ANDA Candidates

ANDA Candidates

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 Pipeline

Product Brand US Sales Indication Clinical/BE Studies FDA Filed FDA Approved
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.

Generic Focalin XR®

Our lead generic product candidate, generic Focalin XR® (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 generic Focalin XR®.

According to Symphony Health Solutions, sales for the 12 months ended August 2017 of Focalin XR® in the U.S. were approximately $802 million (TRx MBS Dollars).

Generic Effexor XR®

Our second generic product candidate in our pipeline is venlafaxine hydrochloride extended release capsules, a generic version of the marketed drug Effexor XR®. This product is currently the subject of an Abbreviated New Drug Application (ANDA) filing with the FDA and is available for partnering.

Effexor XR® is an extended-release capsule for oral administration that contains venlafaxine hydrochloride. It 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$693 million for the 12 months ended August 2017 (TRx MBS Dollars).

Generic Protonix®

Our generic version of the marketed drug Protonix® is a delayed release pantoprazole sodium. This product is currently the subject of an ANDA filing with the FDA and is available for partnering.

Protonix® is a delayed-release capsule for oral administration that contains pantoprazole sodium. Protonix® 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$337 million for the 12 months ending August 2017 (TRx MBS Dollars).

Generic Glucophage® XR

Our metformin hydrochloride extended-release capsules are a generic version of the marketed drug Glucophage® XR. In February 2017 the FDA granted approval of our Generic Glucophage XR for the 500 mg and 750 mg strengths and this product is available for partnering.

Glucophage is an oral antihyperglycemia drug used in the management of type 2 diabetes. According to Symphony Health Solutions, sales of Glucophage® XR were approximately US$528M billion for the 12 months ending August 2017 (TRx MBS Dollars).

Generic Seroquel XR®

Another product candidate in our generics pipeline is quetiapine fumarate extended-release capsules. It is a generic version of the marketed drug Seroquel XR® sold in the United States by Astra Zeneca Pharmaceuticals. 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 October 2016, the Company also announced it had entered into a license and commercial supply agreement with Mallinckrodt LLC, by which the Company has granted Mallinckrodt an exclusive license to market, sell and distribute in the United States its ANDA for generic Seroquel XR® under a 10-year agreement.

Mallinckrodt launched all strengths of our generic Seroquel™ in the U.S. market in June 2017.

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 Seroquel XR® were approximately US$557 million for the 12 months ending August 2017 (TRx MBS Dollars).

Generic Lamictal® XR™

A sixth product candidate in our generics pipeline is lamotrigine extended-release tablets. It is a generic version of the marketed drug Lamictal® XR™. This product is currently the subject of an Abbreviated New Drug Application (ANDA) filing with the FDA and is partnered with Mallinckrodt LLC. In October 2016, the Company announced it had entered into a license and commercial supply agreement with Mallinckrodt, by which the Company has granted Mallinckrodt an exclusive license to market, sell and distribute in the United States its ANDA for generic Lamictal® XR™ under a 10-year agreement.

Lamotrigine is an anticonvulsant drug used in the treatment of epilepsy. According to Symphony Health Solutions, U.S. sales of Lamictal XR™ were approximately US$531 million for the 12 months ending August 2017 (TRx MBS Dollars).

Generic Keppra XR®

A seventh product candidate in our generics pipeline is levetiracetam extended release tablets. It is a generic version of the marketed drug Keppra XR®. 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. The Company's newly approved product is a generic equivalent for the corresponding strengths of the branded product Keppra XR® sold in the United States by UCB, Inc.

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 August 2017 were approximately $134 million (TRx MBS Dollars).

Generic Pristiq®

An eighth product candidate in our generics pipeline is desvenlafaxine extended-release tablets. It is a generic version of the marketed drug Pristiq®. This product is currently the subject of an Abbreviated New Drug Application (ANDA) filing with the FDA and is partnered with Mallinckrodt LLC. In October 2016, the Company announced it had entered into a license and commercial supply agreement with Mallinckrodt, by which the Company has granted Mallinckrodt an exclusive license to market, sell and distribute in the United States its ANDA for generic Pristiq® under a 10-year agreement.

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 August 2017 for Pristiq® were approximately $582 million (TRx MBS Dollars).

Generic Ranexa®

A ninth product candidate in our generics pipeline is ranolazine extended-release tablets. It is a generic version of the marketed drug Ranexa®. 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 August 2017 for Ranexa® were approximately $926 million (TRx MBS Dollars).

Generic COREG CR®

A tenth product candidate in our generics pipeline is carvedilol phosphate extended-release capsules. It is a generic version of the marketed drug Coreg CR®, used in the treatment of heart failure and hypertension.  According to Symphony Health Solutions U.S. sales for Coreg CR® were approximately US$214 million for the 12 months ending August 2017 (TRx MBS Dollars).


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.

Partnership Opportunities

With the help of our partners, we apply our proprietary delivery platform technologies and expertise in pharmaceutics, drug delivery and drug manufacture with the goal of minimizing the risk, time and manufacturing cost of bringing the finished product to market.

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