Mumbai-based pharmaceutical manufacturer Lupin recently received FDA approval for its generic version of Roche’s Tamiflu® (oseltamivir phosphate), one of the most popular antivirals prescribed for relief from the influenza virus. The active ingredient is indicated for the treatment of acute, uncomplicated influenza A and B in patients two weeks of age or older who have been symptomatic for no more than forty-eight hours. The drug comes in capsule form in strength amounts of 30 mg, 45 mg, and 75 mg.[1]
This FDA approval comes near the end of a particularly dangerous flu season, which scientists consider to rival the swine flu pandemic of 2009.[2] The latest report from the Centers for Disease Control and Prevention (“CDC”) in the first week of February notes that 7.7% of reported patients visiting hospitals nationwide -nearly 1 out of every 13 hospital patients- have come in with flu-like symptoms, including a temperature of 100°F or greater and cough and/or sore throat.[3] This is well above the national baseline of 2.2%.[4] The report further explains how there has been a significant increase in deaths resulting from the virus, especially in vulnerable populations such as children and the elderly, with over 60 reported pediatric deaths thus far across the country.[5]
As the flu vaccine has only proven to be about 30% effective against this year’s most prevalent virus strain, prescriptions of treatments like Tamiflu® are on the rise.[6] In a market currently worth over $500 million a year in U.S. sales, Lupin is right on time for the party, joining pharmaceutical competitors Natco, Macleods, Nesher, Alvogen, and Amneal, who also received FDA approvals for generic oseltamivir phosphate capsules and/or oral suspensions in 2016 and 2017.[7] This new competition is finally leveling the playing field with Roche, who has dominated the market since obtaining FDA approval for the Tamiflu® oral capsules and suspensions in 1999 and 2000, respectively.[8]
Notably, Lupin should face little to no opposition from Roche in bringing the generic to market. While Roche, in addition to Genentech and Gilead Sciences, the collective owners of U.S. Patent No. 5,763,483 for Tamiflu®, sued Lupin in a Maryland federal court in 2015 for patent infringement based on an intent to market the drug before the patent expires in 2021, the parties were able to come to a settlement agreement and the case was dismissed in May of 2016.[9]
[1] FDA Drug Approval for ANDA 208348, available at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208348 (last accessed on February 12, 2018).
[2] Mike Stobbe, This Year’s Flu is Now as Bad as the 2009 Sine Flu Epidemic, CDC Says, TIME, available at http://time.com/5143232/cdc-flu-epidemic/ (last accessed on February 12, 2018).
[3] Centers for Disease Control and Prevention, 2017-2018 Influenza Season Week 5 ending February 3, 2018, available at https://www.cdc.gov/flu/weekly/#S6 (last accessed on February 12, 2018).
[4] Id.
[5] Id.
[6] Centers for Disease Control and Prevention, Vaccine Effectiveness- How Well Does the Flu Vaccine Work, available at https://www.cdc.gov/flu/about/qa/vaccineeffect.htm (last accessed on February 12, 2018).
[7] FDA Approvals for Oseltamivir Phosphate, available at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process (last accessed on February 12, 2018).
[8] Id.
[9] Gilead Sciences, Inc. et al. v. Lupin Pharmaceuticals, Inc., No. 1-15-cv-02793 (D. MD May 12, 2016).