Wednesday, January 1, 2014

Legacy 2010 Schering-Plough Omeprasole Patent Suit (Branded As Prilosec® And As Zegerid® OTC) Against Par Pharma Nears Settlement?

Merck's Prilosec®, acquired by Merck as part of the Schering-Plough bust up, or more precisely, the chemical compound omeprasole bi-carbonate, has been the subject of several different patent suits. [So too has been Santarus' Zegerid® OTC -- also an omeprasole bicarbonate. UPDATED 01.01.2014 @ 3 PM EST: Friendly commenter Bearwalk correctly points out that the Zegerid branded version was in-licensed to Schering-Plough Consumer Health -- and so, is also (post November 2009) a Merck Consumer Health product. Thanks, for the able assist!] Most recently, Par Pharmaceuticals had filed an ANDA at FDA, back in 2010, to sell a generic version omeprasole ulcer treatment capsule -- and has been selling its generic since July 2010.

Subsequently, the Federal Circuit reversed the New Jersey District court, here, and held that the invalidation of the patents for "obvious-ness" -- was an incorrect decision. Now the case is back in New Jersey's federal District Courts -- on motion practice. The central goal of those proceedings is to try to figure out what -- if any -- payments will be made, by Par (or less probably, to Par) for these 2010 to 2013 generic ulcer drug sales. Sales of omeprasole in 2011 were around $200 million in the US.

Based upon a review of the United States District court filings in Cause No. 10-CV-04837, in Newark, New Jersey, it would seem that the Par omeprasole patent spat is nearing an agreed settlement. [Twice now, a judge-present settlement conference date -- to settle all claims and counter claims -- was postponed, for additional background discovery, by each side.]

I'll have much, much more -- when we know better what the most likely terms -- governing the license/entrance of the Par generic version have turned out to be. [In any event, the payment to Merck is likely to be less than 10 per cent of the three years' sales -- or around a maximum of $60 million -- and possibly quite a bit less than that.] Do stay tuned, with me. . . and Baby 2014!

Enjoy the bowl games -- and the ice packs -- for your heads (post champagne).


Bearwalk said...

Minor point for completeness, Zegerid OTC is in-licensed and marketed by Merck Consumer...from the legacy SP business.

Condor said...

Thanks so very much, Bearwalk -- you are (of course) 100 per cent right. [I must have still been feeling my two sips of champagne from last night. . . Heh.]

And so. . . Happy New Year!

Just revised my copy above -- to reflect your insight -- thanks again!

Well done!


Anonymous said...

Happy New Year Condor!
Hope you've recovered from the partying.

Off topic; is Ed done with Pharmalot? I get this message when I try to view the site:

"UBM Canon has ceased the production of the following brands: Med Ad News,, Pharmalot, eKnowledgeBase and R&D Directions.

Thank you for your loyalty and support that has played such an important part over the last thirty years.

We invite you to visit MedTech World or UBM Canon for additional industry news and media resources."

Condor said...


Thanks Anon -- I'll give him a call on his cell.


Condor said...

You can be almost certain he will reappear as an (again) independent.

I will let everyone know -- by new post -- when he reappears!

Thanks again -- Namaste!