This one is for all the drug companies...Will there ever be a generic Humalog/Novolog insulin available?
- 1 decade agoFavorite Answer
Anita is correct, although you should know that technically speaking, insulin is treated by the FDA as a small molecule drug (not a biologic medicine). What this means is that while vaccines and most biologic drugs are governed under the Public Health Services Act, which would have to be amended to allow for generics, because insulin and Human Growth Hormone (HGH) were already on the market Hatch-Waxman was signed into law, the law considers them small-molecule “drugs” which are governed by the Federal Food, Drug & Cosmetic Act, therefore generics are legally permitted right now. Furthermore, the patents for Eli Lilly & Company’s Humulin insulin products expired in 2001, and Novo Nordisk’s Novolin insulin products expired in 2002, so patent protection for these pruducts is not at issue. But the major manufacturers still have a few years on the newer insulin analogs. For example, Lilly's Humalog and Novo Nordisk's Novolog rapid-acting insulin analogs have patent protection until 2014; I believe Lantus has patent protection until 2015, and Levemir has patents that run through 2017 before being challenged by biogenerics.
But as Anita noted, a major impediment has been the FDA's refusal to outline procedures for manufacturing or how manufacturers could obtain approval. In August 2006, four state governors, looking to ease drug costs under state programs, petitioned the FDA to provide guidelines for generic versions of insulin and somatropin/human growth hormone (HGH). In their petition, the governors joined other critics in accusing the Agency of dragging its feet.
“The FDA’s delay in informing manufacturers of the requirements for obtaining approval of therapeutically equivalent versions of insulin and HGH has cost the states and other health-care providers hundreds of millions of dollars,” the petition said. Democratic Governors Kathleen Sebelius of Kansas and Jim Doyle of Wisconsin joined Republicans Tim Pawlenty of Minnesota and James Douglas of Vermont in signing the petition. Since then, the governors of New Mexico, Virginia and West Virginia have also signed the petition.
A spokesman named Brian McClung speaking on behalf of Minnesota Gov. Tim Pawlenty added that before generic insulin products could be released, the FDA must create manufacturing standards, which they have not done. “It’s been 22 years,” McClung said. “There is no scientific reason for the FDA not to do this, especially when American patients spend $1.5 billion a year on insulin.”
The FDA is slowly but surely being forced to move. In May 2006, the Sandoz unit of Novartis sued the FDA and won in a lawsuit on the FDA's refusal to provide a decision on an application for generic human growth hormone known as Omnitrope. Omnitrope has been available since last year.
The FDA is also being forced by legislators. In February 2007, Senator Hillary Rodham Clinton, Senator Charles Schumer and Representative Henry Waxman introduced legislation (S. 623/H.R. 1038, the "Access to Life-Saving Medicine Act of 2007") that would give the FDA the express legal authority to approve cheaper, generic versions of biotech drugs known as biologics or follow-on protein products, thus eliminating any excuses they now rely on for failure to move on the issue.
But whether generic insulins emerge is a complex subject that is impacted by regulatory inaction, political lobbying from major drug makers, and basic economics. I have written a complete article on this subject which you can read here:
Hope the article proves enlightening!
- Anonymous1 decade ago
First of all, the patents have not expired on humalog/novolog insulin yet, however older insulins such as humulin have expired patents but there are no generics for those either. That is because the FDA has not supplied guidelines to the generic companies on what they need to do have their generic insulin approved. The FDA was supposedly developing guidelines back in 2001, but it never did. Until these guidelines are produced, no generic insulin.
Interesting bit of trivia; did you know that Banting and Best sold the patent for insulin for only $1 in order for cheap insulin to become quickly available? They would probably roll over in their graves to see what Lilly is charging these days!Source(s): Diabetes Health June/July 2007 issue
- Anonymous1 decade ago
Banting and Best took insulin from dogs and used it in humans. Subsequently the insulin widely used was from pork/beef. Current Regular insulin is synthetic, however, so I don't see how the original patent would apply anyway.
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