Innovator OSI Pharma announced (in a press release Here) the receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals USA, Inc. submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Tarceva® (erlotinib) 25, 100, 150 mg/tablet. Following patents are listed in Orange Book for this product:
US5747498 (Expiry: Nov 8, 2018): Which covers Erlotinib as product
US6900221 (Expiry: Nov 9, 2020): Which covers a homogeneous crystalline polymorph of the hydrochloride salt of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-Quinazolinamine designated the B polymorph that exhibits an X-ray powder diffraction pattern having characteristic peaks expressed in degrees 2-theta at approximately 6.26, 12.48, 13.39, 16.96, 20.20, 21.10, 22.98, 24.46, 25.14, and 26.91.
US7087613 (Expiry: Nov 9, 2020): Which covers a method of monotherapy for a subject suffering from abnormal cell growth expressing the epiderinal growth factor receptor (EGFR) which comprises orally administering to the subject a therapeutically effective amount of a homogenous crystalline polymorph of the hydrochloride salt of N-(3-ethynylphenyl)-6,7-bis (2-methoxyethoxy)-4-quinazolinamine designated the B polymorph that exhibits an X-ray powder diffraction pattern having characteristic peaks expressed in degrees 2-theta at approximately 6.26, 12.48, 13.39, 16.96, 20.20, 21.10, 22.98, 24.46, 25.14, and 26.91 so as to treat the subject, wherein the abnormal cell growth is brain cancer, squamous cell cancer, bladder cancer, gastric cancer, pancreatic cancer, hepatic cancer, glioblastoma multiforme breast cancer, head cancer, neck cancer, esophageal cancer, prostate cancer, colorectal cancer, lung cancer, renal cancer, kidney cancer, ovarian cancer, gynecological cancer, thyroid cancer, non-small cell lung cancer (NSCLC), refractory ovarian cancer, or head and neck cancer.
OSI is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva and expects to file suit in that time frame. A lawsuit brought with respect to one or more of those patents would restrict the FDA from approving Teva's ANDA until May 18, 2012 (the statutory stay period), unless an adverse court ruling occurs prior to such time.
The earliest ANDA filing date for this product was November 18, 2008, accordingly, generic player filed their ANDA with Para IV certification to get 180 days exclusivity for this molecule. Earlier, innovator got approval to market Tarceva® (Erlotinib) 25, 100, 150 mg/tablet on Nov 18, 2004
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