Product Pipeline :: Intellipharmaceutics International Inc.

Product Pipeline

Product	US Market Size	Indication	Clinical/BE Studies	FDA Filed	FDA Approved
NDA
Oxycodone hydrochloride ER	$1.36B*	Pain	Clinical/BE Studies Phase complete	FDA Filed Phase in progress	FDA Approved Phase not started
Regabatin™	$5.47B*	Neuropathic Pain	Clinical/BE Studies Phase in progress	FDA Filed Phase not started	FDA Approved Phase not started
ANDA
Dexmethylphenidate	$867M*	ADHD	Clinical/BE Studies Phase complete	FDA Filed Phase complete	FDA Approved Phase in progress
Metformin	$210M*	Diabetes	Clinical/BE Studies Phase complete	FDA Filed Phase complete	FDA Approved Phase in progress
Venlafaxine	$803M*	Depression	Clinical/BE Studies Phase complete	FDA Filed Phase complete	FDA Approved Phase in progress
Pantoprazole	$375M*	GERD	Clinical/BE Studies Phase complete	FDA Filed Phase in progress	FDA Approved Phase not started
Quetiapine	$153M*	Schizophrenia	Clinical/BE Studies Phase complete	FDA Filed Phase complete	FDA Approved Phase in progress
Lamotrigine	$518M*	Epilepsy	Clinical/BE Studies Phase complete	FDA Filed Phase in progress	FDA Approved Phase not started
Levetiracetam	$130M*	Epilepsy	Clinical/BE Studies Phase complete	FDA Filed Phase complete	FDA Approved Phase in progress
Desvenlafaxine	$275M*	Depression	Clinical/BE Studies Phase complete	FDA Filed Phase complete	FDA Approved Phase in progress
Ranolazine	$997M*	Chronic Angina	Clinical/BE Studies Phase complete	FDA Filed Phase in progress	FDA Approved Phase not started
Carvedilol	$260M*	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 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.

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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