With our new administration, this is getting to be real heated topic and everyone has their points. Right now with some medications not having a generic equivalent, patents are being challenged to bring a generic to market sooner. One of the oldest methods used for years has been to –re-invent a drug with a time released formula to extend the patent timeline.
This case is interesting in the fact that for 3 weeks a generic equivalent was on the market and cost someone his job at Bristol. Existing patents are being challenged by generic manufacturers and in some cases just because the opportunity is there, they can right now in the hopes of providing a cheaper, less expensive drug if they are successful with the challenge. In a related story, Merck and Teva are going through a similar situation with Singular’s patent being challenged.
In addition, there’s the heated battle over Bio-Similar drugs facing Congress.
“The terms "Biosimilar" or "Follow-on Biologic" refer to products that are marketed after expiration of patents, which are claimed to have similar properties to existing biologic products. Due to the complexity of biologics, a product can only be made that is similar, but not identical.”
Plavix also has some heat coming from another area, medical devices in clinical trials to use to thin blood, so another area of potential competition. The NIH is also funding a study with generic testing to determine if this information will lead to better treatment plans with Warfarin, the generic blood thinner. We have also had statements made indicating such studies are not “cost effective” in all areas, with the risk management side chiming in.
Plavix – What’s the next step for doctors and patients – possible genetic testing in the near future?
Will Plavix itself be subject to genetic testing and what effects does the drug have on kidneys and the liver? Patents, genomic testing and competition from potential medical devices certainly leave a lot on the table for discussion with Plavix, not to mention lawsuits that are intermingled, and what does the FDA recommend for labels? It is time for a “reboot” here?
Between the marketing battles, generic information unfolding, studies, device competition, labeling with the FDA, and last but not least the patent issues, where is is all going to end up as it’s a very complex and confusing matter. BD
Bristol-Myers Squibb is paying $2.1 million to end the FTC probe into its negotiations to delay generic competition for Plavix, the company’s blockbuster blood thinner. Those 2006 negotiations were something of a debacle — a generics maker wound up briefly flooding the market with generic Plavix, and the Bristol-Myers CEO left the company.
Earlier this year, the FTC sued a company called Solvay over a generics deal regarding AndroGel, a testosterone product. (The company said the deal was lawful and would lead to earlier generic competition.) And last year, the FTC sued Cephalon in a similar matter involving the anti-drowsiness drug Provigil. (Cephalon says it followed the law.)
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