Celgene Corporation (NASDAQ: CELG) 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.
Diabetes drugs cut asthma attacks by up to 70%, reshaping treatment options