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 -- -- 533.97 805.38 883.66 976.07 992.07 1,033.63 1,019.38
  Flomax 958.41 888.36 511.06 212.96 132.46 93.92 75.33 64.60 55.16
TOTAL losartan potassium 627.55 584.86 672.09 681.37 724.95 783.63 806.75 855.64 868.40
  Generic losartan potassium -- -- -- 339.26 602.06 686.84 723.10 779.93 798.94
  Cozaar 627.55 584.86 672.09 342.11 122.89 96.79 83.65 75.71 69.47
TOTAL losartan potassium/hctz 415.14 387.53 438.71 435.16 452.67 480.74 487.07 506.22 506.20
  Generic losartan potassium/hctz -- -- -- 204.28 365.20 412.48 428.64 453.55 458.56
  Hyzaar 415.14 387.53 438.71 230.88 87.47 68.26 58.43 52.68 47.65
TOTAL pramipexole dihydrochloride 229.12 208.61 232.80 221.14 216.36 229.78 227.97 233.42 228.96
  Generic pramipexole dihydrochloride 90.46 137.48 177.27 178.85 181.28 197.98 200.75 208.46 206.55
  Mirapex 138.67 71.12 55.53 42.29 35.08 31.80 27.23 24.96 22.41
TOTAL anastrozole 136.62 124.59 139.81 133.74 130.99 135.33 139.85 145.39 143.71
  Generic anastrozole -- -- -- -- -- 0.79 88.20 118.08 122.85
  Arimidex 136.62 124.59 139.81 133.74 130.99 134.53 51.66 27.32 20.87
TOTAL imiquimod 68.49 62.14 72.17 70.78 64.88 69.23 66.25 71.67 65.49
  Generic imiquimod -- 0.16 28.54 45.18 48.39 56.40 56.48 62.95 58.61
  Aldara 68.49 61.98 43.63 25.59 16.48 12.83 9.77 8.72 6.88
*In thousands Note: Some totals in charts may be +/- 1 or 2 due to rounding Source: SDI Health

 

Those patent losses will come on the heels of what already has occurred in 2009 and 2010. Several major drugs already have been exposed to generic competition over the past year, including Effexor and Flomax.

Loss of patent protection for all these drugs will open a multibillion-dollar window of opportunity for generic suppliers. According to IMS Health, some 20 pioneer drugs that represent more than $100 billion in total sales are scheduled to run out their patent-protected market exclusivity by 2015.

Much of that impact will occur sooner than that. “Ninety-two billion dollars of products are going to go off-patent by 2014,” Doug Long, VP industry relations for IMS, declared in a presentation to chain pharmacy executives Aug. 30.

“Generics are now 75% of the market,” he added, “and this is [before] the patent cliff that happens between now and 2014, when you’re going to see six or more of the top 10 products losing patent protection.”

Generics also now represent 19% of total U.S. prescription sales, according to Long, and 81% of the total pharmaceutical market now is available for generic substitution, meaning that “the generic efficiency rate is about 92% in the marketplace,” he said. What’s more, Long added, “it’s still a very competitive market. Most of the major molecules have 10 different competitors, and price competition is very intense.”

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