Sun Pharma gains 180-day marketing exclusivity for generic Exelon in the US
02 Jul 2010
Mumbai: Sun Pharma has announced launch of generic Exelon, rivastigmine tartrate capsules for the US market, following the USFDA's final approval for Sun's ANDA to market these products in four strengths.
Exelon is a registered trademark of Novartis.
Sun said in a statement that these generic rivastigmine capsules are therapeutically equivalent of Novartis Exelon capsules and include four strengths: 1.5 mg (base), 3 mg (base), 4.5 mg (base) and 6 mg (base). These strengths of Exelon have annual sales of approximately $130 million in the US.
Being one of the first-to-file an ANDA for the new drug with a para IV certification, Sun Pharma shares a 180-day marketing exclusivity.
Rivastigmine tartrate is indicated for the treatment of mild to moderate dementia of the Alzheimer's type and for the treatment of mild to moderate dementia associated with Parkinson's disease.
Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd, is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.
In India, the company has a strong presence in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, orthopedics and ophthalmology.