The Landscape for Brand and Generic Drugs

San Antonio—With more patented drugs reaching the patent cliff—the expiration of a patented drug that allows for the production of generics to compete—this will affect therapies and is expected to account for $74 billion in sales between 2013 and 2016.

A session, titled Branded and Generic Drugs in Development, given at the AMCP meeting discussed brand and generic drugs in the pipeline and was presented by Chris Peterson, PharmD, Director in the Emerging Therapeutics department at Express Scripts.

The overall trend of the drug industry is moving toward specialty therapies. While the industry on the whole expanded by 2.7% in 2012, most of that was driven by an increase of 18.4% in specialty drugs, while traditional drugs declined by 1.5%. Drugs whose patents expired totaled $158 billion from 2001 through 2012. Prices for patented and generic therapies have diverged sharply; while the price index for brands rose from $100 to $165.44 since 2008 (a 12.5% increase), the index for generics declined from $100 to $57.38 (a decrease of 24%) in that time period.

Dr. Peterson noted that 2012 was a significant year for patent expirations, as drugs accounting for more than $34 billion in sales expired last year. Though the next few years will not see such a seismic change from brand to generic, substantial movement will occur, according to Dr. Peterson. Drugs accounting for $74 billion in sales will go off patent between 2013 and 2016. Some of the most significant drugs to go off patent in 2012 include duloxetine, valsartan, omega-3-acid ethyl esters, esomeprazole magnesium, glatiramer acetate, aripiprazole, and imatinib.

In addition, there were 22 traditional therapies approved in 2013; most of which were indicated for diabetes, cholesterol, and hypertension. Although diabetes is projected to have the most significant impact on individuals in the coming years, hypertension among Americans—both diagnosed and undiagnosed—is the most significant condition of the 3, as nearly 1 in 3 people in this country are potentially affected by the condition.

Of the biologics and drugs available for diabetes, there will be limited new generics, especially for older classes of drugs, but there will be new insulins available, including an inhalable variation, coming in the next few years.

As for the treatments for high cholesterol, there generics and new drugs will continue to crop up in the pipeline in the yeas ahead. Omega-3-acid ethyl esters, ezetimibe and simvastatin, rosuvastatin, and ezetimibe will all come off patent between 2014 and 2016, said Dr. Peterson. It is expected that generic versions of icosapent ethyl and omega-3-acid ethyl esters will debut in 2014, and 5 new specialty drugs for high cholesterol, 2 of which are presently in Phase 3, will debut as soon as 2016. For high blood pressure, patents will expire for 3 significant therapies—olmesartan, amlodipine and valsartan, and telmisartan—between now and 2016.

Of the most prevalent conditions affecting the pharmaceutical marketplace, Dr. Peterson said obesity is the most important. The most prominent options for obesity are benzphetamine, diethylpropion, phendimetrazine, phentermine, orlistat, lorcaserin, and phentermine/topiramate. Phentermine is the dominant therapy in the market, accounting for 82% of prescriptions. Obesity therapies have had a history of safety concerns (eg, fenfluramine/phentermine, etc), but lately there have been new drugs launched and moderate pipeline activity.

The newest obesity therapies that have been approved and launched are lorcaserin and phentermine/topiramate, with expected approvals in 2014 for liraglutide and buproprion/naltrexone.

Asthma and chronic obstructive pulmonary syndrome could prove to have the most fascinating future, said Dr. Peterson, with indications, new inhalers, and a total of 8 new therapies for these conditions coming in 2014. In addition, the patent for fluticasone/salmeterol, expires August 23, 2016, increasing the possibility for the first generic inhaler.

For the central nervous system, including therapies for Alzheimer’s disease, migraine, depression, and schizophrenia, generics are on the horizon, but no breakthrough therapies have been indicated at this point. In the shadow of pressure for the FDA to intensify regulation and prescribing guidelines, new opioids are trending toward moderate pipeline activity with the possibility of generics in the future.

The next groups of therapies to move from prescription to over-the-counter could be nasal steroids and esomeprazole magnesium for the acid reflux.