Blockbuster Medications to Soon See Generic Competition

San Diego—Several leading blockbuster medications will soon lose patent protection in the years ahead, providing potential cost savings opportunities for patients and plan sponsors—at least temporarily. This was one of the conclusions from a session at the AMCP meeting that explored brand and generic drugs currently in development. The session was led by Chris Peterson, PharmD, director emerging therapeutics department, Express Scripts.

According to Dr. Peterson, significant numbers of brand-name drugs are losing patent protection opening the door for more generic medications. In 2014, brand-name drugs with annual sales totaling $16 billion lost patent protection and in 2015 that figure is estimated to be about $25 billion.

Some of those expected to lose patent protection are blockbuster drugs for several therapy classes. For instance, a generic to compete with esomeprazole already became available this year and generic competition for aripiprazole and memantine tablets are also expected this year. A first generic for glatiramer acetate was also approved in April; however, launch information has not yet been released.

“The availability of these generics will continue to provide effective, lower-cost medications to help provide a cost savings to patients and plan sponsors,” Dr. Peterson said. “However, as the patent wave continues to mature, the savings from new generic medications will be outweighed by increasing costs of brand medications.”

In the diabetes market, several trends are apparent. Dr. Peterson said growth is expected to continue among newer classes of diabetes medications; the introduction of new ultra long-acting insulins are expected and biosimilar medication to insulin glargine are also on the horizon.

A new class of diabetes medications came on the market in 2013 when canagliflozin, a sodium-glucose cotransporter (SGLT-2) inhibitor, was released. Since then, 2 additional SGLT-2 inhibitors were approved in 2014.

“The use of the SGLT-2 inhibitors is expected to increase as physicians become more familiar with these medications. In 2014, this market was valued at about $1 billion in sales. However, it is expected to at least triple in size over the next 5 years,” said Dr. Peterson.

A second ultra long-acting insulin, insulin degludec, is also expected to receive FDA approval at the latter part of 2015. These ultra-long acting insulins, the first of which was Sanofi’s insulin glargine 300 units/mL, provide longer durations of action compared to other commonly used long-acting insulins.

Several manufacturers are also working on competing drugs for insulin glargine, which Dr. Peterson said currently represents about 75%  of the long-acting insulin market.

Chronic obstructive pulmonary disease (COPD) is another area of focus for drug developers given its growing prevalence in the population. The first long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) combination inhaler were approved in 2013 and the trend is expected to continue. Two different LABA/LAMA drugs, Boehringer Ingelheim’s olodaterol/tiotropium and Novartis’ glycopyrronium/indacaterol, are currently under FDA review.

“The LABA/LAMA inhalers are expected to represent one-third of all sales in the COPD market within the next 5 years,” he said.

Drug developers of pain medication are searching for new ways to deter abuse of such medications in response to a growing public health problem. In recent years, the FDA has approved abuse-deterrent labeling for 5 different products and is currently reviewing 3 more.

Dr. Peterson said that by the end of 2015, Collegium’s oxycodone/naltrexone e.r. and Teva’s hydrocodone e.r. are all expected to earn FDA approval.

One trend in the pipeline for drugs used to treat the central nervous system is the expected approval of 4 new schizophrenia drugs. Within the cardiovascular market, generics are expected to continue to influence the market with competition from generics expected in 2016 for rosuvastation and ezetimibe.

Other pipeline trends include 1 medication, LCZ-696, to treat patients suffering from heart failure. Shortly after this session, on April 14, ivabradine was FDA approved for heart failure.

The introduction of proprotein convertase subtilisin/kexin type 9 inhibitors is also on the horizon this summer with the anticipated approval of 2 such medications. These specialty drugs are used to lower low-density lipoprotein cholesterol.

While initially these drugs are expected to treat small patient populations their use could expand over time. “Although pricing has not been established, these therapies are expected to have an annual cost of between $4000 and $12,000,” said Dr. Peterson. “These therapies are expected to achieve blockbuster status.”—Jill Sederstrom