Adderall manufacturer, Shire Pharmaceuticals, cannot seem to stay out of
trouble with the U.S. Dept. of Justice and consumers. First, in October
2014, the company settled claims of deceptive marketing and agreed to
pay more than $56.5 million. Now, they have been sued because of a “Pay
for Delay” scheme with a generic drug manufacturer resulting in
higher prices to consumers in violation of antitrust laws.
Here is how the scheme works. Under Federal law, when manufacturers of
a brand name drug like Adderall (used for attention deficit disorder or
“ADD”) come into the market they apply for and receive a patent
which makes them the exclusive manufacturer and distributor of that drug
for a fixed period of time. As the end of the patent period nears, or
if there was a dubious extension of the patent, generic drug manufacturers
file with the FDA forms known as “abbreviated new drug applications”
which puts everyone on notice of their intention to enter the market as
a generic manufacturer of that particular drug.
Lately, it has become common practice for the brand drug manufacturer to
then sue the generic manufacturer for alleged patent infringement. In
reality, all the lawsuit does is delay the generic drug manufacturer from
entering the market and allows the brand manufacturer - in this case,
Shire – to continue to sell billions of dollars of the branded drug
at the expense of the consumer. Then, after a period of time, the brand
and generic manufacturer settle the patent infringement case with the
brand manufacturer paying off the generic manufacturer - effectively paying
for their delay to enter the market.
Why should a consumer of Adderall care?
A consumer should care because as long as there is a delay in the entry
of a generic to the market place, the consumer is paying either a dramatically
inflated price for the drug or, if insured, they are paying a higher co-pay
than he should.
If you or a loved one was prescribed Adderall XR between April, 2009 and
June, 2012 you may have paid an inflated price or co-pay for the drug
as a result of this ‘’pay for delay” scheme. If you
have questions about your legal rights, please call the dangerous drug
lawyers at Golomb & Honik, P.C.