The relevant patent expires on July 2. If DRL gets US Food and Drug Administrations approval for its generic version of the drug, with the subsequent 180-day exclusive marketing rights attached to a para IV success, it will be the only generic player during the period and is likely to capture around 50% of the market share.
A para IV filing is made when the applicant believes its generic product does not infringe the innovators patent or when it feels that the patent is not valid or enforceable. The applicant (if it obtains approval) gets a 180-day exclusivity window to market the generic drug if it is the first to file the application that is called an abbreviated new drug application (ANDA). Drug makers who get success on this front rake in quick money as they side-step competition during this period of exclusivity.
According to the US DMF listing, DRL is the only applicant to file for this product in the first qarter of 2013. DRL is the sole DMF filer (on Latuda) so far and, hence, this could be a potential first to file abbreviated new drug application, wrote Girish Bakhru, analyst with HSBC Securities and Capital Markets in a research report on April 9.
Currently, US-based Sunovion holds a single patent for Latuda (generic name Lurasidone). Although the patent will expire in early June, the new chemical entity exclusivity expires on October 28, 2015, which is when the first generic can hit the market.
The Hyderabad-based drug maker has filed four ANDAs during the October-December quarter of 2013 fiscal. According to the companys FY13 third-quarter report: Cumulatively, 65 ANDAs are pending for approval with the USFDA of which 35 are para IVs and eight have first to file status. However, the company said, We do not comment on details specific to the pipeline, when asked to provide details on the first to file status drugs.
The US market contributes 44% of generics revenue for DRL. Vidaza, Dacogen and a couple of niche opportunities are some of the pending approvals over next few months, which should accelerate US growth. However, over the recent years the revenue opportunity provided by para IV filings have significantly gone down from $24 billion in 2007 to $3 billion in 2012.
The number of such filings has also come down from a peak of 67 in 2008 to 48 in 2011 and 19 in 2012. Analysts said the decline was largely because of drying up of blockbuster products or molecules with annual brand sales of over $1 billion in the US market.