Patent cliff to bring short-term boon to generic industry
NEW YORK — Look for a big surge in brand-to-generic drug switches at the pharmacy counter over the next year.
Pharmaceutical industry experts agreed that 2011 will bring a flood of me-too medicines to U.S. prescription dispensaries, thanks to a looming “patent cliff” that will see some of the industry’s biggest-selling blockbusters emerge from the shelter of their patent-protected sales exclusivity, and into the harsh light of generic competition for the first time. The change in status will upend established dispensing patterns for such therapeutic categories as heart and cholesterol medications, and will spawn a new sales race among generic drug makers.
For the branded pharmaceutical industry, “2011 is basically going to be a bloodbath,” observed Melissa Leonhauser, director of strategic marketing for SDI.
Products expected to lose patent protection in 2011
PRODUCT | TOTAL Rx* | SEPTEMBER 2010 RETAIL SALES† |
Actos | 11,179.44 | $220.95 |
Aricept | 6,576.68 | 135.72 |
Aricept ODT | 17.56 | 0.39 |
Lipitor | 38,516.28 | 447.09 |
Plavix | 25,216.43 | 401.58 |
Zyprexa | 3,620.53 | 172.45 |
Zyprexa IM | 3.07 | 0.38 |
Zyprexa relprew | 1.33 | 0.34 |
Zyprexa zydis | 238.77 | 14.51 |
TOTAL MARKET | 85,370.09 | $1,393.06 |
*In thousands; for the 52 weeks ended September 2010 | ||
† In millions | Source: SDI Health |
Among the branded drugs whose patent life is scheduled to expire is Takeda Pharmaceuticals’ Actos, a blockbuster medicine in the thiazolidinedione class of medications that treat Type 2 diabetes by increasing the body’s sensitivity to insulin.
Other big-name medicines that face the widely anticipated end-of-patent protection next year include Pfizer’s hugely successful cholesterol medication Lipitor, the world’s largest-selling prescription drug; Plavix, an antiplatelet compound marketed by Bristol-Myers Squibb and Sanofi-Aventis for the prevention of strokes and heart attacks; Zyprexa, an antipsychotic from Eli Lilly for the treatment of schizophrenia and bipolar disorder; and Aricept from Eisai and Pfizer, a centrally acting reversible acetylcholinesterase inhibitor to treat dementia.
Number of total prescriptions of products that lost exclusivity in 2010*
PRODUCT | JANUARY | FEBRUARY | MARCH | APRIL | MAY | JUNE | JULY | AUGUST | SEPTEMBER |
TOTAL venlafaxine HCL | 1,099.94 | 1,017.85 | 1,150.23 | 1,081.22 | 1,046.99 | 1,091.98 | 1,096.25 | 1,114.03 | 1,094.93 |
Generic venlafaxine ER | 117.03 | 117.97 | 135.32 | 130.93 | 130.66 | 138.82 | 643.75 | 788.22 | 797.31 |
Effexor XR | 982.90 | 899.87 | 1,014.91 | 950.29 | 916.34 | 953.16 | 452.50 | 325.81 | 297.62 |
TOTAL tamsulosin HCL | 958.41 | 888.36 | 1,045.04 | 1,018.33 | 1,016.12 | 1,069.99 | 1,067.40 | 1,098.23 | 1,074.53 |
Generic tamsulosin HCL | -- | -- | 533.97 | 805.38 | 883.66 |