Here is a timely press release, filed by Celgene and posted on Yahoo Finance, which relates to our ongoing discussion concerning the high cost of anti-multiple myeloma chemotherapy medications:
Celgene Expects to Receive a Paragraph IV Notification of an ANDA Filing for REVLIMID®
SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ: CELG – News) today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a “Paragraph IV” patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.
Celgene intends to vigorously enforce its extensive intellectual property rights for REVLIMID and will file a complaint alleging infringement of Celgene patents after the notification letter is received. REVLIMID is currently protected by 12 issued patents listed in the FDA’s Approved Drug Products List (Orange Book) and has additional patent applications pending. The issued patents cover REVLIMID’s composition of matter, method of use, and polymorphs, as well as Celgene’s RevAssist® system, the restricted distribution program as approved by the FDA. In order for the filer to prevail, the relevant patent claims must be deemed invalid, not infringed or expired.
The prevailing argument is, without patent and FDA protection, drug companies like Celgene–which may invest many years and millions of dollars developing a new cancer drug–won’t make the research commitments necessary to get these new drugs to market.
Hard to argue with that. But what about the patient? Think about all of the dollars saved if a generic equivalent of Revlimid was brought to market–especially now that maintenance therapy using Revlimid is becoming the new standard of care– even after a patient completes a stem cell transplant.
I can concede it is probably too early to expect to see generic Revlimid. But isn’t it time for Thalomid (thalidomide) to go generic? After all, hasn’t it been around for more than 50 years?
Let’s get to the bottom of this! More about the generic drug process tomorrow–and why Thalomid is still under Celgene’s control.
Feel good and keep smiling! Pat