Synthon sued for generic tadalafil and believes to be "FTF" for 180 days exclusivity

Synthon has been sued by Eli Lilly and Icos Corporation in connection with the filing of Synthon's ANDA for Tadalafil 20 mg. Synthon's Tadalafil 20 mg Tablets product is a generic and bioequivalent version of Lilly's and United Therapeutics’ Adcirca® tablets which is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability. Synthon believes that it is the ’Single First Filer’ of an ANDA with a Paragraph IV certification for the Adcirca® (Tadalafil) tablets, 20 mg. As a result, Synthon expects to be eligible for 180 days of Hatch-Waxman exclusivity upon the first commercial marketing of their generic drug product.

Impax confirms Patent Challenge against Colesevelam HCl tablets, 625 mg

Impax has initiated a challenge against patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) tablets, 625 mg by filing an ANDA containing a para IV certification for a generic version of WELCHOL® with the USFDA. Following receipt of the notice from the FDA that Impax's ANDA had been accepted for filing, Impax notified the NDA holder and patent owners of its paragraph IV certification. On January 14, 2010, Daiichi Sankyo, Inc. and Genzyme Corporation filed suit for patent infringement against Impax in the United States District Court for the District of Delaware. This action formally initiates the patent challenge process under the Hatch-Waxman Act. Based on the filing date of the ANDA, the Company believes that it is the first to file an ANDA with a paragraph IV certification and expects to be entitled to 180 days of market exclusivity. Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's generic division, will commercialize the products.

WELCHOL® is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin), reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after failing an adequate trial of diet therapy, and improve glycemic control in adults with type 2 diabetes mellitus. According to Wolters Kluwer Health, U.S. sales of WELCHOL® were approximately $308 million for the twelve-month period ending November 2009.

Mylan sued for its generic version of Vytorin by Schering and MSP Singapore

Mylan has been sued by Schering and MSP Singapore Company in the US District Court for the District of New Jersey alleging patent infringement for filing an ANDA with the USFDA for Ezetimibe and Simvastatin tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg. This product is the generic version of Vytorin tablets. Mylan says that it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the product and expects to qualify for 180 days of sole marketing exclusivity once final US FDA approval is obtained. Vytorin Tablets had approximately US$ 1.6 billion in sales for the same strengths for the 12 months ending September 30, according to IMS Health.