A Total of $3.38 Billion, in Annual Revenues at Risk, by April 2012.
Yesterday afternoon, Schering Corporation — along with a German company that holds the patents on Levitra® — sued Teva Pharmaceuticals alleging patent infringement. That drug is sold for — ahem — erectile dysfunction, but don’t laugh too quickly, as it is represents about $430 million in annual revenues, as a franchise, for Schering-Plough. On May 19, 2009, Teva wrote the German company to inform it of Teva’s intention to file an Abbreviated New Drug Application (ANDA) with FDA — for a generic equivalent tablet, containing the same active ingredient in Levitra — Vardenafil Hydrochloride. The action is captioned Schering Corporation, et al. v. Teva Pharmaceuticals, et al. (Case No. 09-480, U.S. Dist. Ct., Del., Complaint Filed July 1, 2009). From the complaint:
. . . .[Levitra] Patent No. 6,362,178 expires March 28, 2018. . . .
But that is likely not going to be the most critical expiry date, for Levitra. No, Levitra’s most critical expiry date may now well come as early as April of 2012 (see table below). How so?
Well, let’s review the larger narrative here, then: even though many on Wall Street tout Schering-Plough’s relative dearth of formal patent expiries (most after 2014; many in the 2017 to 2019 time-frame) — there is another side to this story.
That “other side” involves the right, under the various Hatch-Waxman amendments, of competing manufacturers to launch generic versions of most of these drugs, “at risk” — on the earlier to occur of (1) a favorable outcome in patent litigation (the Temodar trial is complete; now awaiting a decision from the bench), (2) 30 elapsed months from the filing of a patent lawsuit, coupled to FDA approval of an abbreviated new drug application (Note that the Clarinex “at risk” date could come at any moment — should FDA approve Orchid’s ANDA), or (3) the formal expiration of the relevant as-granted patents.
In one convenient table, then, as I’d earlier detailed, below are some of the larger Schering-Plough franchises with looming near-term “in substance” patent cliffs [now with Levitra's potential Teva woes, included]:
| Branded Name |
Sales ($M/Yr) |
Compound Name |
First Suit Filed |
30 Month Expiry/
“At Risk” Date |
Likely Competitor
|
| Clarinex® |
$800 Million |
Descloratadine |
September 2006 |
May 2009* |
Orchid Pharma* |
| Zetia® |
$900 Million |
Ezetimibe |
March 2007 |
October 2009 |
Glenmark Pharma |
| Temodar® |
$950 Million |
Temozolomide |
July 2007 |
January 2010 |
Barr Labs (Teva Pharma)
|
| Integrilin® |
$300 Million |
Eptifibatide |
February 2009 |
November 2011 |
Teva Pharma |
| Levitra® |
$430 Million |
Vardenafil HCl |
July 2009 |
April 2012 |
Teva Pharma |
| Total: |
$3.38 Billion |
.. |
.. |
.. |
.. |
~~~~~~~~~~~~~
* All but one potential generic Descloratadine manufacturer has agreed to a standstill until January 2012, for generic launches. I believe the one remaining is Orchid Pharmaceuticals, out of India.
~~~~~~~~~~~~~
This may well turn out to be nothing, but last night, Magistrate Judge Falk signed an order postponing a case management conference in MDL 1938, formerly known as Polk, et al. v. Schering-Plough Corporation, et al. (Case 08-285) — the putative classs action alleging consumer fraud as a result of the delayed disclosure of the ENHANCE study.
