Thursday, June 4, 2015

More And More Are "Summarily Ghosted": Integrilin® Is Now (June 2, 2015) Off-Patent -- In The US

This legacy Schering-Plough drug was once one of "Fast Fred" Hassan's "stars". As with all things ephemeral and beautiful, though, the bloom fades from the rose, in time. . . . Oh, but what a time it was. Smile. . . Where was I?

Ah. . . No more, though. While this development has been forecast by yours truly for over six years, it has been four years since the franchise sold $300 million or more in a year. Here is my own 2010 era overall patent expiry chart.

[And, taking a cue from our earlier efforts, a few years ago, Kenilworth began making a very similar chart available, in its SEC-filed '34 Act periodic reports.] You may inspect that, at page 9 of the current SEC Form 10-K, where we see the fully up-to-date chart. Finally, we'd point out that this week's ghosting is only one of many, already endured in these last 34 months -- so this one is immaterial to the overall fortunes of Merck. Here's a bit of a look back, at the legacy Schering-Plough infringement complaint against Teva, from 2009:

. . . .[Legacy Schering-Plough's Infringement Complaint]

. . . .20. By letter[s] dated January 8, [and February 13,] 2009 (the “Notice Letter”), Teva notified Millennium and Schering that it had submitted to the FDA ANDA No. 90-854, for Teva’s Eptifibatide, Injection, 2 mg/mL, 10 mL Vial and 100 mL Vial, a drug product that is a generic version of INTEGRILIN® (“Teva’s ANDA Product”). The purpose of the submission of the ANDA was to obtain approval under the Federal Food, Drug, and Cosmetic Act (“FDCA”) to engage in the commercial manufacture, use, offer for sale, and/or sale of Teva’s ANDA Product prior to the expiration of the ['447,] ‘825 [and '902] patent[s]. . . .

22. In the Notice Letter, Teva also notified Millennium and Schering that, as a part of its ANDA, Teva had filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to the ‘825 patent. Upon information and belief, Teva submitted ANDA No. 90-854 to the FDA containing a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the ‘825 patent is invalid, unenforceable, and/or will not be infringed by the manufacture, use, offer for sale, or sale of Teva’s ANDA Product. . . .

28. Upon information and belief, Teva intends to engage in the manufacture, use, offer for sale, sale, marketing, distributing, and/or importation of Teva’s ANDA Product with its proposed labeling immediately and imminently upon approval of ANDA No. 90-854. . . .

[To close out the record-refresher here: this product is still the subject of pending qui tam litigation in California federal District Court, for the Eastern District -- though that is (I think) likely to be dismissed, in time, for technical reasons.] I guess we are all destined to become ghosts, in due course -- it's just that some of us become them, sooner rather than later. Onward. Ah, well. . . so it goes, but I will need to know whose DNA she harbors, “Roger” that. . . Onward


Anonymous said...

Only because you once mentioned that you liked them~~concerns on the horizon?

Condor said...

Excellent! Thank you! I'll keep an eye "peeled" for more news -- on this... Ahem.


Condor said...

It would seem that bananas are now in short supply, in my favored grocer, in Chicago.

You called it, here, Anon.

Sad. But true.

Ugh. Namaste -- just the same.