Celgene Officially Notified Of ANDA Filing For REVLIMID

Celgene Corporation (NASDAQ: CELG) announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA). The application requests authorization to manufacture and market generic versions of REVLIMID® (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.
Celgene intends to vigorously enforce its extensive intellectual property rights for REVLIMID and plans to file a complaint alleging infringement within the required 45-day response period. 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 comprise composition of matter, polymorph and method of use claims as well as claims related to Celgene’s proprietary RevAssist® system. In order for Natco to avoid liability, all patent claims in the suit must be deemed invalid, not infringed, unenforceable, or expired.
About REVLIMID
REVLIMID® is an IMiDs® compound. REVLIMID and other IMiDs continue to be evaluated in over 100 clinical trials in a broad range of hematological and oncological conditions. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions, including composition-of- matter and use patents.
REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 50 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.
REVLIMID is also approved in the United States, Canada and several Latin American countries, as well as Malaysia, Israel, Japan, Australia and New Zealand for transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorization Applications are currently being evaluated in a number of other countries.
REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
REVLIMID® (lenalidomide) is indicated for patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Source:
Celgene Corporation