Marketed & Developmental Products

The following table summarizes the status of products marketed, approved and/or under development by Noven.

Product

Indication

Regulatory Status

Marketing Rights

Noven Therapeutics

Pexeva®
 (paroxetine mesylate)

Depression, panic disorder, OCD & GAD Marketed in U.S. Noven
Lithobid®
 (lithium carbonate) 		Bipolar disorder Marketed in U.S. Noven
StavzorTM
 (valproic acid softgel) 		Bipolar disorder, migraine & epilepsy Tentative approval
received December 2007		 Noven
Lithium QD
(once-daily lithium) 		Bipolar disorder Clinical program
under review		 Noven
StavzorTM ER
(extended release valproic acid softgel) 		Bipolar disorder, migraine & epilepsy Pre-clinical Noven
MesafemTM
 (low-dose paroxetine mesylate) 		Vasomotor symptoms (hot flashes) Phase 3 scheduled
for 2008		 Noven

Transdermal Hormone Therapy

Advanced Generation Estrogen
Vivelle-Dot®/
Estradot®

 Menopausal Symptoms/
Osteoporosis
FDA-approved; Approved in over 45 foreign countries Novogyne1--U.S.  Aventis2--Japan
Novartis Pharma3--all other territories

Combination
Estrogen/Progestin CombiPatch®/Estalis®

 Menopausal Symptoms/
Osteoporosis 		FDA-approved; Approved in over 30 foreign countries

Novogyne--U.S.
Aventis--Japan
 Novartis Pharma--all other territories
Transdermal ADHD    
Methylphenidate
DaytranaTM
 ADHD FDA-approved;
EU filing planned by Shire
Shire4--worldwide
Amphetamine ADHD Pre-clinical Shire--worldwide
Other Transdermals   
Undisclosed Hypoactive Sexual Desire Disorder On hold P&GP5--worldwide
Transmucosal 
Lidocaine/DentiPatch® Dental pain associated with certain dental procedures FDA-approved Noven
1
 Novogyne Pharmaceuticals is a joint venture between Noven and Novartis Pharmaceuticals Corporation.
2
 Aventis S.A.
3
 Novartis Pharma AG.
4

Shire plc
5

P&G Pharmaceuticals has indicated that its HSDD development program in the U.S. is currently on hold.

Copyright © 2008 Noven Pharmaceuticals, Inc. All rights reserved.