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Patent cliff to bring short-term boon to generic industry

11/15/2010

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*










































































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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