New Delhi: Indian drugmaker Sun Pharma received a tentative approval from the US drug regulator for generic version of Januvia late last week, fuelling speculation among analysts that the company has challenged the patent on the blockbuster anti-diabetes drug.
This comes as a surprise as Sun has partnered the US based multinational Merck Sharp & Dohme (MSD) in the domestic market to sue Glenmark for the patent infringement on the same drug. While confirming the tentative approval from US Food and Drug Administration (US FDA), a Sun Pharma spokesperson told ET that it can't comment on the nature of filing.
The earliest that Sun can launch the generic version of the drug is in 2022. However, industry experts say an application filed 12 to 14 years before the patents for the drug are set to expire is most likely to be a Para IV application. Apara IV filing means Sun has either challenged the validity of MSD's patent on Januvia (on the monophosphate or the product it markets) or submitted that its generic version wouldn't infringe MSD's patent.
While patent related to Januvia basic compound is set to expire on 2022, patents related to the salt or product (the monophosphate version that is marketed) will only expire in 2026 in the US. "If you check the date on which Sun Pharma filed its abbreviated new drug application for the salt Januvia, it is 18 October 2010, which is two days after NCE-1 date, a cut-off date for filing a Para IV application," an analyst said on condition of anonymity.
Two other generic players which have filed their application around the same time are US based generic giant Mylan and Sandoz, the generic arm of Swiss drugmaker Novartis. Sun Pharma's India strategy on Januvia got firmed up only in 2011 when it entered into an agreement with MSD for marketing, promoting and distributing MSD's diabetes products, including Januvia.
"We are not in litigation with Sun Pharma in the US for sitagliptin (generic name for Januvia). Filing of or tentative approval by USFDA does not provide a right to put the generic product sought in the ANDA on the market till the patent expiry date, which in this case is 2022. We have not taken any legal action against Sun, nor any other generic in the US, as they have taken a position of respect for the basic sitagliptin compound patent," a MSD spokesperson said.
"Assuming, Sun's application is of para IV type, MSD can still legally challenge Sun Pharma before 2022 and if it doesn't, it would have to be ready for a generic version of the drug in the US market, at least four years before its patent on the salt (Januvia) actually expires," the analyst said. Earlier this month, MSD sued Glenmark alleging that two its recently launched anti-diabetes drugs infringe its patent coverage of drugs Januvia and Janumet.
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