As innovaters prep for patent cliff, generics prosper from patent losses
A whole slew of drugs will lose patent protection this year, opening up opportunities for generic drug makers to market their own versions. Most notable among these is Pfizer’s cholesterol- lowering drug Lipitor (atorvastatin), the world’s top-selling drug, with U.S. sales of $7 billion during the 12 months ended September 2010, according to IMS Health.
Other important drugs facing generic competition over the next few years include the cardiovascular drug Plavix (clopidogrel) by Sanofi-Aventis and Bristol-Myers Squibb, and Eli Lilly schizophrenia and bipolar disorder drug Zyprexa (olanzapine), which had annual sales of $5.8 billion and $2.8 billion during the 12 months ended September 2010, respectively. Though Sanofi and BMS recently scored a victory when the Food and Drug Administration extended the pediatric exclusivity period for Plavix until 2012, the party will soon be over, or it will at least wind down a bit.
The year 2014 marks the patent cliff, at which point most of the top-selling drugs will have lost patent protection. Generic drug companies have grown significantly on the strength of generic versions of blockbuster drugs, but after 180 days of market exclusivity in which to compete with the branded version, a molecule becomes fair game for any generic manufacturer, thus commoditizing it so much that the innovator sometimes has to pull the branded version from the market.
While branded and generic drug companies alike have sought refuge in biologics and follow-on biologics, the market for drugs to treat such widespread conditions as cardiovascular disease won’t necessarily go dry. According to a recent report by the Pharmaceutical Research and Manufacturers of America, 299 drugs are in development for treating cardiovascular disease, with 16 applications filed with the FDA seeking approvals for new drugs or new uses for existing drugs. Perhaps amid those 299 drugs lie some blockbusters to be.
Industry advocates tout increase in generics use
Generic drug usage already has been on the rise year after year, with no sign of slowing down. As Jody Fisher, VP marketing for healthcare analytics at market research firm SDI, has told Drug Store News, generics accounted for more than 70% of products dispensed at retail pharmacies and are set to increase further this year.
But a recent recommendation by the Department of Health and Human Services could boost generics even more. In a document released earlier this month, HHS secretary Kathleen Sebelius urged governors of all 50 states to increase use of generics in state Medicaid programs, winning praise from such groups as the Pharmaceutical Care Management Association, a trade group representing pharmacy benefit managers. According to the Generic Pharmaceutical Association, Texas was able to save about $223 million by changing prescription pads to make it easier for doctors to prescribe generics, while federal and state governments together could save more than $2.9 billion per year with a 5% increase in generic utilization.
But generic drug makers could face some trouble as well, particularly with a bill proposed in early February by Sen. Patrick Leahy, D-Vt., which would make the biggest changes to patent laws in more than 60 years. While the GPhA and the Pharmaceutical Research and Manufacturers of America — the lobby that represents branded drug companies — both praised the bill on the whole, the GPhA expressed concerns about changes that it said could weaken the inequitable conduct provision, a provision that has enabled generic drug companies to challenge patents covering branded drugs. “We don’t think that patent reform should weaken the inequitable conduct provision,” GPhA interim executive director Bob Billings told DSN. “If it does, you’ll see slower times for generics to come to market.”
Currently, a patent can be ruled invalid in court if the court determines that the patent holder intentionally withheld information or deceived the Patent and Trademark Office. Generic drug companies wishing to launch before the branded version’s patent expires will include in their regulatory filing with the Food and Drug Administration a Paragraph IV certification, a legal assertion that the patent is invalid, unenforceable or won’t be infringed. If the judge can find inequitable conduct, the generic company can launch its version of the drug. Generally, the branded drug company will file a lawsuit, but in most cases, the two reach a settlement that still allows generic launch ahead of patent expiration.
ReportersNotebook — Chain Pharmacy, 2/28/11
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The Food and Drug Administration approved Sun Pharmaceutical Industries’ generic version of Johnson & Johnson’s Alzheimer’s drug, Razadyne (galantamine hydrobromide) tablets. Razadyne has annual sales of about $50 million, according to Sun.