First Time Generic Approvals in 2013
Opana ER (oxymorphone) Extended-Release previously made by Endo Pharma
The fate of the generic is in question - the FDA has banned generic versions of the powerful narcotic OxyContin (oxycodone extended-release) to help curb the growing U.S. prescription abuse epidemic.
Zometa (zoledronic acid) by Novartis
Novartis’ attempt to fend off generic competition by extending the patent life with an added indication to prevent breast cancer recurrence failed in 2010.
Propecia (finasteride) by Merck
The FDA has approved a generic version from several manufacturers. According to IMS Health, the Propecia brand generated over $140 million in sales in 2011.
Tricor (fenofibrate) by Abbott
Teva, Ranbaxy, and Mylan are now all making the more affordable generic fenofibrate.
Valcyte (valganciclovir) by Genentech
Valcyte, approved in 2001, generated roughly $224 million in U.S. sales for Genentech in 2011. Valcyte is projected to lose patent protection in 2015, and the FDA has tentatively approved the generic 450 mg oral tablet formulation of valganciclovir by Ranbaxy.
Zomig, Zomig ZMT (zolmitriptan) by Impax Laboratories
In 2011, both Zomig brand products brought in over $150 million in U.S. sales for manufacturer Impax Laboratories. Zomig Nasal Spray has patent protection until 2021.
Visicol (sodium biphosphate/sodium phosphate) by Salix Pharmaceuticals
Visicol has not been a fast mover for Salix - sales of Visicol slipped after the FDA required a black box warning for serious kidney damage in 2008.
Fosamax Plus D (alendronate and cholecalciferol) by Merck
Fosamax D contains a combination of alendronate and cholecalciferol (vitamin D) for osteoporosis and is the second bisphosphonate to reach generic status in 2013 - after Zometa. Fosamax Plus D brought in $30 million in U.S. sales in 2011.
Rilutek (riluzole) by Sanofi
Sanofi garnered roughly $39 million in 2010 Rilutek U.S. sales.
Temodar (temozolomide) by Merck
Temodar tallied roughly $173 million in 2011 U.S. sales, but loses patent protection in August 2013. Recent animal studies suggest temozolomide combination therapy with an investigational FAK inhibitor CFAK-Y15 may lengthen survival, and research is ongoing.
Cerezyme (imiglucerase) by Genzyme
Niaspan (niacin extended-release) by AbbVie
The utility of Niaspan has been recently questioned in clinical trials, showing no clinical benefit when added to statin therapy. Nonetheless, Niaspan brought in $768 million in the first three quarters of 2012.
Advicor (lovastatin/niacin extended-release) by AbbVie
Advicor posted $42 million in U.S. sales in 2011 and is positioned for generic availability in Q3 of 2013.
AcipHex (rabeprazole) by Eisai
Originally approved in 1999, AcipHex is slated to go generic in May 2013. Sales of the brand approached $900 million in 2011.
Vivelle-DOT (estradiol transdermal) by Novartis
Recent research suggests that it is safe for most newly menopausal women to use oral or transdermal estrogen to combat menopausal symptoms - but for how long requires more study.
Cymbalta (duloxetine) by Eli Lilly
A vigorous advertising campaign in the U.S. appears to have boosted recent sales. Since January 2011, Cymbalta has brought in over $6.5 billion in U.S. sales, and ranked as the overall 5th best-selling drug in 2012. The patent covering brand name Cymbalta expires in December 2013.
- IMS, Medco Health. Estimated Dates of Possible First-time Generics/Rx-to-OTC Market https://host1.medcohealth.com/art/corporate/anticipatedfirsttime_generics.pdf
- Top 15 Drug Patent Losses for 2013. FiercePharma.com Special Reports. 11/1/2012. Accessed 4/01/2013. http://www.fiercepharma.com/special-reports/top-15-patent-expirations-2013
- U.S. Food and Drug Administration (FDA). Drugs@FDA. FDA Approved Drug Products. Accessed 5/7/2013. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm