First Time Generic Approvals in 2013

Opana ER (oxymorphone) Extended-Release previously made by Endo Pharma

The generic version of the older, non-tamper resistant formulation of the opioid analgesic Opana ER (oxymorphone extended-release) was launched on January 4, 2013. Impax Laboratories had 180 days of market exclusivity on the generic painkiller whose brand generated over $334 million in the last half of 2011.

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.

Oxymorphone hydrochloride, Extended-release 5 mg Oral Tablet

Zometa (zoledronic acid) by Novartis

In 2011, Novartis reported Zometa sales close to $1.5 billion. The bone-strengthening drug contains zoledronic acid in the class known as bisphosphonates. The Zometa brand lost patent protection in March 2013.

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

Merck's Propecia (finasteride) is a 5-alpha-reductase inhibitor used to combat male pattern baldness. Originally approved in 1997, Propecia lost patent protection in January 2013.

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

Tricor (fenofibrate), a fibrate used to lower triglycerides and cholesterol, lost patent protection in Q1 2013, opening the doors for generic versions. Abbott's Tricor was originally approved in 2004, and in 2011 reeled in close to $1.1 billion in U.S. sales.

Teva, Ranbaxy, and Mylan are now all making the more affordable generic fenofibrate.

Valcyte (valganciclovir) by Genentech

Valcyte (valganciclovir) is an antiviral medication used to treat AIDS-associated cytomegalovirus (CMV) retinitis - a viral inflammation of the retina in the eye that can cause blindness - and to prevent CMV infection in patients receiving organ transplants.

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

Zomig and Zomig-ZMT both contain zolmitriptan, a serotonin agonist migraine treatment. The generic tablets were approved in May of 2013. Apotex Corp., Glenmark Generics and Mylan Pharmaceuticals, Inc. have indicated that distribution of their products will commence immediately.

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, a tablet taken orally to cleanse the bowel before a colonoscopy procedure, contains sodium biphosphate and sodium phosphate. Visicol is scheduled to become available generically in May of 2013.

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

Merck's bone-strengthening Fosamax lost patent protection in 2008, and now their Fosamax Plus D is scheduled to switch to generic status in June of 2013.

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

According to the FDA, Rilutek (riluzole) was approved generically in 2003 and is marketed by Impax Labs. Rilutek is an orphan drug for the treatment of patients with amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease. The treatment helps to protect nerve cells by decreasing the levels of glutamate in the body, and may prolong survival and/or time to breathing assistance.

Sanofi garnered roughly $39 million in 2010 Rilutek U.S. sales.

Temodar (temozolomide) by Merck

Temodar (temozolomide) is an orphan drug that was FDA-approved in 1999 for the treatment of brain cancers such as aggressive glioblastomas. Patients with glioblastomas may only have an average of 15 to 18 months to live.

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

Patients with the ultra rare type 1 Gaucher disease produce low levels of the glucocerebrosidase enzyme needed for fat metabolism. Low enzyme levels result in organ damage due to fat accumulation, anemia and bone lesions. Cerezyme (imiglucerase) replaces glucocerebrosidase in type 1 Gaucher disease. Genzyme reported that Cerezyme sales approached $178 million in Q4 2011 alone. The orphan drug is expected to lose patent protection in August of 2013, possibly opening the door for biosimilars.

Niaspan (niacin extended-release) by AbbVie

Abbott's Niaspan, an extended-release version of niacin approved to increase levels of the so-called 'good' cholesterol (HDL), is due to lose patent protection in September 2013.

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, FDA-approved to treat high cholesterol, is an extended-release version of niacin combined with the original statin - lovastatin. In 2012, the lovastatin label was updated with warnings and dose adjustments for important drug interactions that can increase the risk for muscle injury.

Advicor posted $42 million in U.S. sales in 2011 and is positioned for generic availability in Q3 of 2013.

AcipHex (rabeprazole) by Eisai

AcipHex (rabeprazole) is a proton-pump inhibitor (PPI), one of the popular acid-suppressing drugs for the relief of heartburn (GERD) and other stomach-related conditions. AcipHex is not available over-the-counter yet, like other popular PPIs, Prevacid 24HR and Prilosec OTC.

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

Vivelle-DOT is a transdermal skin patch used to help prevent menopausal symptoms such as hot flashes and vaginal dryness, and also for osteoporosis prevention. Novartis recorded over $230 million in Vivelle-DOT sales in 2011, but the generic should be available by the end of 2013.

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

Eli Lilly's blockbuster Cymbalta (duloxetine) was approved in 2004 for depression, and has also received approvals for anxiety, fibromyalgia and nerve and muscle pain.

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.

 

Sources

  • 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
Hide
(web2)