Zyflo is a drug that makes my nose and lungs work better. It's currently ridiculously expensive, but the patent's running out. How can I find out when someone will make it generic?
Here's the deal: I have a condition called Samters Triad, or Aspirin triad. It's asthma, aspirin sensitivity, and nasal polyps. It's a huge pain in the ass, but this particular drug, a leukotriene inhibitor, works really well for me. Much better than the closest thing, Singulair. Earlier this year, the company adjusted its pricing upwards to around $650 a bottle. So I'm possibly looking at a hefty additional layout next year for this stuff. (I have an RX plan now, but won't have a very good one next year)
However -- the patent on the molecule, Zileuton, expires December 9, 2010. The current formulation has an additional patent because it's extended release, but I don't think this alone would preclude someone from making the standard release version.
The company's yearly filing
In addition, although we own or exclusively license United States patents and patent applications with claims directed to the pharmaceutical formulations of our product candidates, methods of use of our product candidates to treat particular conditions, delivery systems for our product candidates, delivery profiles of our product candidates and methods for producing our product candidates, patent protection is not available for composition of matter claims directed to the APIs of any of our products or product candidates other than ZYFLO CR, ZYFLO and FACTIVE. The composition of matter United States patent for zileuton that is used in ZYFLO CR and ZYFLO will expire in December 2010. The composition of matter United States patent for gemifloxacin mesylate that is used in FACTIVE will expire in April 2017.
When the composition of matter patent for the API in one of our products expires, competitors will be able to offer and sell products with the same API so long as these competitors do not infringe any other patents that we or third parties hold, including formulation and method of use patents. However, method of use patents, in particular, are more difficult to enforce than composition of matter patents because of the risk of off-label sale or use of the subject compounds. Physicians are permitted to prescribe an approved product for uses that are not described in the product’s labeling. Although off-label prescriptions may infringe our method of use patents, the practice is common across medical specialties and such infringement is difficult to prevent or prosecute. Off-label sales would limit our ability to generate revenue from the sale of our product
So far, I've a) googled extensively and found nothing, b) searched FDA's ANDA approvals and Orange Book and found nothing, and c) listened to the company quarterly results conference calls for the past two quarters. None of these things hint at any impending generic release. The rep on the conference call talks rather eagerly about the 2011 allergy season.
What else can I do to see if anyone's thinking of making this stuff? Would no one try for it because of the use patents? Should I expect a price decrease to preemptively disincentivize generic competitors?