Flush generics industry eyes new openings
The stampede of big-selling branded medicines that hurtled off the patent cliff in 2011 and 2012 has slowed to a relative trickle. But with generic drugs now accounting for 86% of all drugs dispensed in the United States, according to IMS Health, the me-too drug market remains a powerful growth industry and one of the few segments within the pharmaceutical arena, along with specialty drugs, that continues to drive overall market momentum for prescription medicines.
“Specialty medicines and generics,” noted the IMS Institute for Healthcare Informatics in a report on 2013 pharmaceutical spending, continue to “outpace growth of traditional small molecules and brands.”
Many of the pharmaceutical industry’s top-selling drugs — products that dominated the pharmacy landscape in the last two decades — have already fallen victim to the loss of patent protection and market exclusivity, retaining just a faded remnant of their former marketing prowess as generic competition ravaged sales and profitability. The list includes such branded former blockbusters as Lipitor and Zyprexa — whose patents expired in 2011 — as well as Plavix, Singulair, Seroquel, Lexapro, Actos and Diovan HCT, all of which were opened to copycat versions in 2012.
“Therapy areas affected by the so-called patent cliff included lipid regulators, anticoagulants, mental health, respiratory treatments for asthma and COPD, hypertension, osteoporosis and allergies,” the IMS Institute reported in April. “In aggregate, this group of classes had $9 billion in lower spending in 2013, mostly due to the impact of patent expiries.”
According to the report, expiries were much more muted in 2013 than in prior years, with Cymbalta — Eli Lilly and Co.’s treatment for diabetes-related pain, fibromyalgia, depression and anxiety — the only billion-dollar product expiring.
What’s more, “the impact of patent expiries in 2013, $19 billion, was dramatically lower than the $29 billion in 2012, both because of smaller and fewer 2013 expiries, and the roll-off of 2011 and 2012 expiries in the first half of 2013,” IMS researchers reported. “Overall spending [on pharmaceuticals] increased in 2013, largely due to lower patent expiry impact than in 2012, and higher contribution from brand price increases.”
The period of relative calm in generic growth momentum could be fairly short-lived. Barring unforeseen actions, the next three years will see the expected expiration of U.S. patent protection for more of the world’s top-selling medicines, including AstraZeneca’s mammoth-selling Nexium, Pfizer’s Celebrex and Sunovion Pharmaceteuticals’ Lunesta in 2014; and Bristol-Myers Squibb’s blockbuster Abilify, Forest Labs’ Namenda and Abbott Labs’ AndroGel folow in 2015. The trend will continue in 2016 with the expected loss of patent life for AstraZeneca’s big-selling Crestor and Seroquel XR; Abbott’s Humira; and Merck’s Zetia.
“From 2014 to 2016, patents will expire for drugs with approximately $51 billion in annual brand-name sales, opening those markets to generic competition,” the Generic Pharmaceutical Association predicted in its 2013 Annual Report. “And there still are ample growth opportunities in drugs that recently lost patent protection, as evidenced by the increasing number of generic applications submitted to the Food and Drug Administration.”
That includes a record 225 applications in December 2013 alone, according to GPhA.
Also buoying the me-too drug industry was the FDA’s decision last year to overhaul the Office of Generic Drugs and elevate it to the status of a “super office.” The reorganization, according to Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, will strengthen the OGD’s operations with new resources for research and standards, bioequivalence review and regulatory issues, allowing the office to “meet the evolving needs of generic drug review.”
To see the charts that accompany the article, click here.