Patent

SpicyIP Tidbit: US Court Rules in Favour of DRL on Prilosec


Last week brought good tidings for DRL which, these days, finds itself regularly in the news. A district court in Southern New York summarily ruled that DRL’s ANDA filing on Omeprazole Mg Over-The-Counter (OTC) version did not infringe Astra Zeneca’s patents on heartburn drug Prilosec.

SpicyIP has dealt with this case in fair detail earlier with a comprehensive discussion of the issues involved by Mr.Chris Ohly. The suit was a typical Hatch-Waxman patent infringement case where Astra claimed that DRL’s omeprazole magnesium having less than 1% crytallinity detectable and manufactured using a different process infringed its US patents 5,900,424 and U.S. Patent No. 5,690,960, both of which cover Prilosec OTC, an over-the-counter version of the original Prilosec product which was earlier available only with a prescription. The Court held otherwise.

Post verdict, DRL said that it would continue with the regulatory approval process and work towards commercialization of the OTC version. Goldman Sachs estimates that DRL is likely to earn $20-35 million in the next financial year from this drug. The Business Standard reported thus:

The OTC brand product clocked sales of over $360 million in the US in 2008. The OTC version of the drug was granted approval by the FDA in 2003, with a three-year marketing exclusivity. Perrigo Pharmaceutical is the only other player to have launched a generic version of OTC Prilosec following its patent litigation settlement with Astra Zeneca in December 2007, according to sources.”

2 comments.

  1. AvatarAnonymous

    Dear Deepak,
    A minor correction for the following statement – Perrigo Pharmaceutical is the only other player to have launched a “generic version of OTC Prilosec” following its patent litigation settlement with Astra Zeneca in December 2007.

    Perrigo’s product is not a generic version of Prilosec OTC; rather it was a New Drug Applictaion filed under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDC Act).
    A 505(b)(2) application is one for which one or more of the investigations relied upon by the applicant for approval “were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted” (21 U.S.C. 355(b)(2)).

    Prilosec OTC of Astra and the Perrigo’s own product does not have any generic in the US market.

    Reply

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